Able to take oral medications
Patients must be able to tolerate oral medications by mouth, and not have a gastrointestinal illness that would preclude absorption of olaparib
No chronic (duration > 30 days) daily use of oral steroids
Patients must be able to take oral medications (i.e., swallow pills whole); patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible
Patients must be able to swallow oral medications without crushing or chewing
Within 90 days prior to registration: Complete dental exam; complete elimination of dental and periodontal pathology including crowns on teeth susceptible to fracture, extraction of non-restorable or periodontally uncorrectable teeth; creation of an oral environment that the patient can efficiently maintain in a high state of health; and oral hygiene instruction to maintain excellent oral health
Patients must not be taking oral glucocorticoids at the time of registration
Subject must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after alisertib administration
Must be able to take oral medication without crushing, dissolving or chewing tablets
Participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide
Participants must be able to take oral medications
Patients must be able to tolerate oral medications
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
Inability to take oral medications
Requirement for > 2 oral hypoglycemic medications for routine diabetic management and control
Treatment with oral or intravenous (IV) antibiotics within 2 weeks prior to Day 1 of Cycle 1
Known active infection requiring parenteral or oral anti-infective treatment within 14 days of randomization.
Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette–Guerin [BCG], oral polio vaccine, and oral typhoid)
An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
Patients may not have been treated for another SCC of the oral cavity, oropharynx, hypopharynx or larynx in the past
Unable to receive oral medications
Unable to receive oral or IV hydration
Able to take oral medication without crushing, dissolving or chewing tablets
Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir)
Ability to take oral medications
Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of BGB-290, which is an oral agent.
Any physical condition that can prevent ability to tolerate oral therapy
Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation, active peptic ulcer or prior surgical procedures or bowel resection affecting absorption
Ability to take oral medications
Any condition that impairs patient’s ability to swallow PD 0332991 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption)
Patients must be able to consume oral medication in the form of tablets or solution
Subject has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
Current treatment with oral or parenteral anti-coagulants/antiplatelet agents
Able to take oral medications
Participants who have had oral targeted therapy or oral tyrosine kinase inhibitors (TKIs) within 5 half-lives prior to entering the study
Ability to ingest oral medications
Able and willing to take oral medications
Able to take oral medications
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Patients must be able to take oral medications
Active oral or genital herpes lesions
Subject has a known gastrointestinal disorder that in the opinion of the treating investigator is concerning for malabsorption of oral medications
Must be able to take oral medication without crushing, dissolving or chewing capsules
Patients must be able to tolerate oral medications and not have gastrointestinal processes that would preclude absorption of olaparib
Adequate oral intake/nutritional status without the need for enteral or parenteral feeding during chemoradiation or preoperative period
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation
estrogen-gestagen based contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal),
gestagen-only based contraceptives associated with inhibition of ovulation (oral, injectable, implantable),
Patient has an inability to swallow oral medications; Note: patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN)
Participant is able to take an oral medication.
Participant is able to take oral medication.
Serious infection requiring oral or IV antibiotics/antifungals/antivirals and/or hospitalization within 28 days prior to screening\r\n* Patients on prophylactic oral antibiotics, antifungals and antivirals due to prolonged neutropenia in the absence of documented infection are eligible\r\n* Patients who are treated with IV antibiotics for neutropenic fever, are eligible if no infectious etiology was determined and the last dose of antibiotics was >= 7 days from cycle 1, day 1
Current or recent use of therapeutic oral or parenteral anticoagulants or thrombolytic agents
Any patient with an open oral ulceration(s) should avoid dosing with AZD4635 oral suspension.
History of allergic reactions attributed to oral vancomycin or oral polymyxin B
T3 Oral Cavity, any N stage; or
Disease at the nasopharyngeal, sinus, oral cavity, or other sub-site not specified
Subject is taking any oral anticoagulant
Gastrointestinal tract disease or any other reasons resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease or chronic diarrhea
Inability to tolerate oral medications.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or the inability to take oral medication
Chronically taking an oral medication known to be a P-gp substrate within 7 days of starting treatment with Oratecan.
Ability to swallow oral medications and maintain an empty stomach state for 2 hours prior to the MLN0128 dose and for 1 hour following administration
Inability to take oral medications
Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs
Ability to take oral medication
Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted
Oral estrogen, progesterone, testosterone therapy within last 3 months
Active serious infection not controlled by oral or intravenous antibiotics
Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0;
Patients must be able to consume oral medication
Patients with any severe gastrointestinal or metabolic condition which could interfere with the \r\nabsorption of oral study medications.
Not able to take oral medication
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must be able to swallow oral medications (capsules) without chewing, breaking, crushing, opening or otherwise altering the product formulation
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients must be able to swallow oral medications (capsules) without chewing, breaking, crushing, opening or otherwise altering the product formulation
COHORT 3: ENDOMETRIAL CANCER: Patients must be able to swallow oral medications (capsules) without chewing, breaking, crushing, opening or otherwise altering the product formulation
Patients must be able to swallow oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
Patient must be able to take oral/enteral medication
Patient must be able to swallow enteral medications with no requirement for a feeding tube; patient’s must not have intractable nausea or vomiting which prohibits the patient from oral medications
Active serious infection not controlled by oral or intravenous antibiotics.
Unable to receive oral medication
Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible
Patients must have the ability to take oral medications
An oral contraceptive OR
Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive
The subject is able to tolerate oral medications and no evidence of ongoing malabsorption
Acute exacerbations of underlying condition within the last 12 months (requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
Gastrointestinal abnormalities causing impaired absorption precluding administration of oral medications
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
Oral or IV antibiotics within 2 weeks prior to enrollment
Ability to receive oral medication
Active serious infection not controlled by oral or intravenous antibiotics.
In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment
No known prior history or current evidence of untreated local gum or oral infection
No known/planned active dental or jaw condition which requires oral surgery, including tooth extraction
No known non-healed dental/oral surgery, including tooth extraction
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with nasojejunal (NJ), jejunostomy (J) or gastrostomy (G) tube will not be allowed to participate
Subjects not able to take oral drugs
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
inability to take oral medication
Able to take oral medication without crushing, dissolving or chewing tablets
Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
Consistent and correct usage of established oral contraception.
inability to take oral medication;
Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
Patients must be able to ingest oral medications (crushing and administering via percutaneous endoscopic gastronomy [PEG] tube is acceptable)
Subjects requiring daily corticosteroids either via oral route of administration (po) or infusion.
An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
Able to tolerate oral medications and no GI illnesses that would preclude absorption of olaparib
Inability to tolerate oral medication
Any condition that impairs the ability to swallow or absorb oral medication (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affective absorption)
Patients have prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, evidence of untreated local gum or oral infection, or non-healed dental or oral surgery
Patients with active dental or jaw conditions which require oral surgery/dental procedures, including tooth extraction for the course of the study
Patients must be able to take oral medications
UROTHELIAL CARCINOMA EXPANSION COHORT: Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib
Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of olaparib, which is an oral agent. For the gastric cancer cohort, patients with a full or partial gastrectomy will be permitted.
Patients not able to swallow oral medications or with gastrointestinal conditions that may impact absorption of dasatinib
Able to take oral medication
Meets one of the following criteria: Is currently on a stable regimen of an oral contraceptive containing 1mg NE and 0.035mg EE, or Is willing to switch to a regimen of an oral contraceptive containing 1mg NE and 0.035mg EE from a stable regimen of an alternate OC, or Is willing to start a regimen of an oral contraceptive containing 1mg NE and 0.035mg EE.
Has a known or suspected carcinoma that is excluded as administration of Oral Contraceptive would be contraindicated.
oral
oral
Ability to swallow oral medications and maintain an empty stomach state for two hours prior to the TAK-228 dose and for one hour following administration
Subjects must be able to consume oral medication
Patients who are unable to take or tolerate oral medications on a continuous basis
Patients must be capable of taking and absorbing oral medications
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agents
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agents
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients must be able to swallow oral medications without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib which are an oral agent
Ability to take oral medication
Be able to take oral medication
Able to take oral medications
Oral or IV antibiotics within 2 weeks prior to enrollment
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
Must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after capsule(s) administration
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with nasojejunal (NJ), jejunostomy (J) or gastrostomy (G) tube will not be allowed to participate
Any underlying condition that would significantly interfere with the absorption of an oral medication
Ability to take oral medication
Subject must be able to take oral medication and to maintain a fast, as is required for 2 hours before and 1 hour after alisertib (MLN8237) administration
Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes
Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes
Patient must be able to take oral medications
Patient must be able to swallow enteral medications with no requirement for a feeding tube; patient’s must not have intractable nausea or vomiting which prohibits the patient from oral medications
Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules
Patients must be able to consume oral medication
Receipt of any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days (>= 96 hours) immediately before randomization.
COHORT 3: ATOPIC DERMATITIS PATIENTS: Use of topical or oral CAM agents within 4 weeks of initiation of treatment
Normal ionized calcium (can be on oral supplementation)
Normal magnesium (can be on oral supplementation)
Normal phosphorus (can be on oral supplementation)
Must be able to take oral medication
Patient should be able to take oral medication (dasatinib must be swallowed whole)
Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs
Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity)
Active serious infection not controlled by oral or intravenous antibiotics
Ability to take oral medication
Patient is able to take oral medications
Chronic use of high-dose oral corticosteroid therapy .
Oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial.
Presence of active infectious oral disease excluding oral candidiasis
Presence of any oral lesions that may confound the ability to assess oral mucositis grade
Presence of active infectious disease excluding oral candidiasis
Presence of oral mucositis or any oral lesion that would confound the assessment of oral mucositis
Active systemic disease or condition known to impact the risk or course of oral mucositis including chronic immunosuppression and known seropositivity for HIV
The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis (for oral therapy only).
Histological evidence of oral intra-epithelial neoplasia within 12 months prior to enrollment; subjects with a history or clinical diagnosis suggestive of oral intra-epithelial neoplasia, or patients with a history of invasive oral cancer are eligible, but must have a confirmed histological diagnosis of oral intra-epithelial neoplasia before randomization; histological evidence of oral intraepithelial neoplasia on an invasive oral cancer resection specimen is acceptable; a visible, measurable, clinical lesion (such as leukoplakia and/or erythroplakia) is not required; only individuals with high risk profiles will be considered eligible for randomization; high risk profiles are defined as patients without a prior oral cancer and have loss of heterozygosity (LOH) at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q,8p,11p,13q, or 17p) or patients with a prior oral cancer history and have LOH at 3p14 and/or 9p21; all high risk patients must also meet the additional eligibility criteria
Subject is unable to reliably take oral medications
Inclusion Criteria:\n\n          1. Previously participated in, and received oral azacitidine, and continues to fulfill\n             the eligibility criteria in one of the parent oral azacitidine clinical trials.\n\n             The Investigator believes the subject is tolerating treatment with oral azacitidine\n             monotherapy and continued oral azacitidine treatment is of benefit to the subject.\n\n          2. Understand and voluntarily sign an informed consent document prior to any study\n             related assessments or procedures being conducted.\n\n          3. Willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n          4. Females of childbearing potential (FCBP) may participate, provided they meet the\n             following conditions:\n\n               1. Have two negative pregnancy tests as verified by the Investigator prior to\n                  starting study therapy. She must agree to ongoing pregnancy testing during the\n                  course of the study, and after end of study treatment. This applies even if the\n                  subject practices true abstinence from heterosexual contact.\n\n               2. Either commit to true abstinence from heterosexual contact (which must be\n                  reviewed on a monthly basis and source documented) or agree to use, and be able\n                  to comply with, effective contraception without interruption, 28 days prior to\n                  starting investigational product, during the study therapy (including dose\n                  interruptions), and for 3 months, or longer if required by local regulations,\n                  after discontinuation of study therapy.\n\n          5. Male subjects must:\n\n               1. Practice true abstinence (which must be reviewed on a monthly basis) or agree to\n                  use a condom during sexual contact with a pregnant female or a female of\n                  childbearing potential while participating in the study, during dose\n                  interruptions and for at least 3 months, or longer if required by local\n                  regulations, following Investigational Product (IP) discontinuation, even if he\n                  has undergone a successful vasectomy.\n\n        Subjects must satisfy the following criteria to participate in the Survival Follow-up\n        phase:\n\n          1. In order to be enrolled for the survival follow-up in the Follow-up Phase of the\n             rollover study, subjects must have been in a parent oral azacitidine study where\n             monitoring for survival was required and have signed informed consent for follow-up\n             phase.\n\n          2. Understand and voluntarily sign an informed consent document for this study.\n\n          3. Willing and able to adhere to the study visit schedule and other protocol\n             requirements.\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from receiving investigational\n        product in the study:\n\n          1. Concomitant use of drugs that are prohibited.\n\n          2. Prior chemotherapy (including injectable azacitidine) or radiotherapy or any\n             investigational agent after the last dose of oral azacitidine administered as part of\n             the parent oral azacitidine study.\n\n          3. Subjects have met one or more criteria for discontinuation as stipulated in the parent\n             oral azacitidine study.\n\n          4. Subjects received oral azacitidine in combination with another compound during a\n             parent oral azacitidine study (Subjects form multi-arm parent oral azacitidine studies\n             will be allowed to enroll into the rollover study, if the subject is receiving\n             single-agent oral azacitidine at the time of transition into the rollover study).\n\n          5. A subject's transition into rollover study ? 45 days after End of the Study visit of\n             the parent oral azacitidine study\n\n          6. Pregnant or lactating females. There are no exclusion criteria to prevent entry or\n             remaining on the follow-up phase of this study
Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
Any underlying condition that would significantly interfere with the absorption of an oral medication
Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
Subjects who are able to take oral medication.
Subjects who cannot tolerate oral administration as determined by the Investigator
Has inability to take oral medications and/or has clinical or radiological diagnosis of bowel obstruction.
Patient has an inability to swallow oral medications; Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN)
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Any medical contraindications or previous therapy that would preclude treatment with either nivolumab, IRX-2, the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
8. Must be able to take oral medications.
Able to take an absorb pill form oral medications
Patient has an inability to swallow oral medications and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
Patients with a current diagnosis of oral mucositis
Patients with pain and oral dysfunction associated with oral mucositis despite conventional therapy
Patients undergoing any other experimental intervention for oral mucositis
Able to swallow capsules, with no surgical or anatomic condition that will preclude the patient from swallowing and absorbing oral medications
Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti convulsants and corticosteroids); itraconazole should not be taken with cisapride (Propulsid), dofetilide (Tikosyn), oral midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quinaglute), triazolam (Halcion), or levomethadyl (Orlaam), lovastatin (Mevacor), simvastatin (Zocor), or an ergot medication such as dihydroergotamine (Migranal), ergometrine or ergonovine (Ergotrate Maleate), ergotamine (Ergomar), or methylergometrine or methylergonovine (Methergine)
All patients must be able to take oral medications
Unable to receive oral medications
Active dental or jaw condition that requires oral surgery, including tooth extraction
Non-healed dental/oral surgery, including tooth extraction
oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
Inability to take oral medications on a continuous basis
Active gastrointestinal tract disease with malabsorption syndrome or unable to swallow oral medications
Stage IVA-B disease of 1) oral cavity, 2) oropharynx, 3) larynx, 4) hypopharynx
Subjects must be able to consume oral medication
Ability to take oral medication (i.e. no feeding tube)
Normal ionized calcium, magnesium and phosphorus (can be on oral supplementation)
Daily oral or intravenous corticosteroids for 7 days or longer within one week of enrollment and patient is anticipated to have an increase in dose after study enrollment
Able to take oral medication and has no history of gastric surgery or pathology
Must have ability to take oral medication
Ability to take oral medications
Subjects willing for repeat oral dosing and follow-up, including pharmacokinetic\n             sampling
Patient is able to tolerate oral medications and does not have gastrointestinal illnesses that would preclude absorption of either olaparib or BKM120 or BYL719
Patient must be able to swallow capsules and have no surgical or anatomic condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis
Calcium (corrected for albumin) within normal limits (oral supplementation is allowed)
Any underlying condition that would significantly interfere with the absorption of an oral medication
Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Malabsorption syndrome or chronic nausea that might hinder absorption and assessment of oral medication
Patient must be tolerating oral intake
According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration; these guidelines may change pending results from an ongoing food effects study
Able to tolerate oral therapy
At least 7 days beyond any infection requiring intravenous antibiotic use (Oral\n             antibiotics may be administered prophylactically as clinically indicated)
A 7-day washout period is required if patients are currently using another oral topical treatment for mouth lesions; patients currently using clobetasol oral topical treatment are not eligible for this study
Patients have an active infection and require intravenous (IV) or oral antibiotics
Evidence of complete or partial bowel obstruction or other unable to take oral medications
Ability to tolerate oral medications
Evidence of complete or partial bowel obstruction or other unable to take oral medications
Unable to swallow oral medications or with pre-existing gastrointestinal disorders.
Pneumonitis that requires oral or IV steroids;
Oral, injected or implanted hormonal contraception
Ability to take oral medications; a gastrostomy tube is allowed
Ability to tolerate oral or enterically-administered medications.
Able to take oral medications
Received therapeutic oral or IV antibiotics within 2 weeks prior to first dosing.
CLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection
Patients on oral anticoagulation therapy
Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator
Oral endocrine therapy </= 2 weeks before study treatment
Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline/randomization visit.
Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
Progesterone only oral contraception, where inhibition of ovulation is not the primary mode of action.
Is unable to take oral medications, has a history of surgery that would interfere with the administration or absorption of oral medication, has malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that might impair the bioavailability of IP
Prior exposure to azacitidine, decitabine or prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative.
Noncompliant with oral medication and/or dexamethasone mouth wash
Patients who are unable to reliably tolerate and/or receive oral medications
Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
No oral or intravenous corticosteroid use within 2 weeks prior to study entry
Known active infection requiring parenteral or oral anti-infective treatment
Have currently active gastrointestinal disease, or prior surgery that may affect the ability of the patient to absorb oral lenalidomide
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with nasojejunal (NJ), jejunostomy (J) or gastrostomy (G) tube will not be allowed to participate
Patients requiring a treatment by oral vitamin K antagonists
Unable to take oral medications
Patient must be able to take oral medications
Patients must be able to ingest oral medications (crushing and administering via percutaneous endoscopic gastrostomy [PEG] tube is acceptable)
Systemic (oral or parenteral) corticosteroids within 14 days of study entry
Patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration
Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel
Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy.
Oral or intravenous iodinated contrast administration =< 6 weeks prior to registration
No acute exacerbations of underlying condition within the last 6 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications
Unable to receive oral medications
Unable to receive oral or IV hydration
Inability to take oral medication
Patient must be able to take oral medications
Taking oral itraconazole
Unable to swallow oral medications, or has gastrointestinal condition deemed to jeopardize intestinal absorption.
Patients must not have gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for intravenously (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
Ability to swallow oral medications and maintain an empty stomach state for 2 hours prior to the MLN0128 dose and for 1 hour following administration
Pre-existing conditions\r\n* Disorders associated with abnormal bone metabolism\r\n* Hypocalcemia that is not corrected with oral calcium supplementation\r\n* Vitamin D < 20 mg/mL\r\n* Paget’s disease\r\n* Prior history or current evidence of osteonecrosis of the jaw\r\n* Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery or planned invasive dental procedures during the anticipated course of study therapy\r\n* Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi syndrome) or congestive heart failure
Ability to take oral medications
Ability to take oral medications
Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
Patients must be able to take oral medications
Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel
Participants must be able to take oral medication
At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Patients must be able to take oral medications
Any underlying condition that would significantly interfere with the absorption of an oral medication
The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis (for oral therapy only)
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain X-82 tablets are excluded
Patients with clinical symptoms or signs of gastrointestinal obstruction, require parenteral hydration or nutrition, require a drainage gastrostomy tube, and/or have any other impairment that limits their ability to take oral medication
Subjects must be able to take oral medications
Inability to take oral medications
Ability to take oral medication;
Patients must be able to take oral medication without crushing, dissolving or chewing tablets
Able to take oral medications
Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
Inability to swallow pills or any significant gastrointestinal diseases, which would preclude adequate absorption of oral medications.
Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin
Ability to take oral medications
Patients who cannot take oral medications
Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of GSK1120212 and GSK2141795
Patients with malabsorption in the small intestine or other conditions that would preclude administration of oral medication
Known active infection requiring parenteral or oral anti-infective treatment
Patients have active dental or jaw condition which requires oral surgery, including tooth extraction
Patients have non healed dental/oral surgery, including tooth extraction
PART B: Patients with inability to take oral medications, or, in the investigator’s opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications
Primary sites other than oral cavity
Able to take oral medication
Patients must be able to take oral medications
Inability to swallow oral medications or any malabsorption condition
Patients with any condition of the gastrointestinal tract that is expected to result in an inability to swallow or absorb oral medications (i.e. prior surgical procedures affecting absorption and requiring intravenous [I.V.] alimentation); this will be determined at the discretion of the principal investigator (PI)
Subjects must be able to consume oral medication
Currently active GI disease, or prior surgery that may affect ability to absorb oral medications
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
Patient must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration
Inability to take oral medications on a continuous basis; patients who are to take pazopanib, sorafenib, or sunitinib and are unable to swallow pills whole are ineligible (the pills cannot be crushed or broken)
Patient should be able to take oral medication (dasatinib must be swallowed whole)
Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded
Able to take oral medications and maintain hydration
Oral retinoid therapy for any indication within 3 weeks of study entry
Patients must be able to take oral medication without crushing, dissolving, or chewing tablets
Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine
Significant malabsorption syndrome or inability to tolerate oral medications
Patients unable to take oral drugs or with known malabsorption syndromes
Patients receiving oral corticosteroids within 30 days of enrollment.
Patient must be able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis
Inability to take oral medication
Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs
Concomitant anticoagulation with oral anticoagulants.
Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications
Clinical conditions affecting the intake and use of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)
progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Gastrointestinal disease that interferes with receipt of oral drugs;
Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
Inability to tolerate oral medications.
Gastrointestinal tract disease or previous surgical procedures resulting in an inability to take oral/feeding tube suspension or enteral medication or a requirement for IV alimentation
Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx
Ability to take oral medication (dasatinib must be swallowed whole)
No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
Active serious infection not controlled by oral or intravenous antibiotics
Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.
Oral or IV antibiotics, antifungals, or antivirals within 1 week, with the exception of prophylactic oral agents. Note: In the event that a subject requires the chronic use of antivirals, Medical Monitor permission is required for entry into the study.
Unless patients have a DLCO-adjusted less than 45%, patients in all groups must have failed either oral or intravenous cyclophosphamide regimen defined as: IV cyclophosphamide administration for at least > 3 months between first and last cyclophosphamide dose at a total cumulative IV dose of at least 2 grams, oral cyclophosphamide administration for > 4 months regardless of dose, or combination of oral and IV cyclophosphamide for at least > 6 months independent of dose
Active dental or jaw condition which requires oral surgery
Non-healed dental or oral surgery
Use of oral bisphosphonates within the past 1 year
Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.
In case of use of oral contraception women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.
No acute exacerbations of underlying condition in the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high potency oral steroids)
Ability to receive oral medication
Has inability to swallow oral medications or presence of a gastrointestinal disorder (e.g. malabsorption) deemed to jeopardize intestinal absorption of MK-8628
Patients have an active infection and require intravenous (IV) or oral antibiotics
Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head & neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology
Any underlying condition that would significantly interfere with the absorption of an oral medication
Patients must be able to take oral medications
Patients who are unable to take oral medications and/or who have a clinical or radiological diagnosis of bowel obstruction are ineligible
Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment
Acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of enrollment
Ability to comply with an oral drug regimen
Ability to take oral medications
Any major surgery or gastrointestinal disease that would interfere with administration of oral medications
Willing and able to take oral medications
Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets
Mechanical obstruction that would prevent adequate oral nutritional intake.
Inability to swallow oral medications or any medical conditions that may affect intestinal absorption of the study agent or inability to comply with oral medication
Known active infection requiring parenteral or oral anti-infective treatment.
Subject must be able to take oral medication and to maintain a fast as required before and after MLN8237 administration
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain tablets are excluded
Chronic ongoing oral steroid use at the time of registration for any condition (such as asthma, rheumatoid arthritis, etc)
Patients should be able to take oral medications
Patients should be able to receive oral medications
Inability to take oral medications, due to impaired swallowing ability or poor absorption capacity
Must be able to ingest, absorb and tolerate oral medication
Ability to take oral medications and willing to record daily adherance to investigational product
Able to take oral medication
Ability to take oral medications
Able and willing to take oral medications
Patient’s pain symptoms have remained stable with no adjustment to analgesics within 7 days prior to randomization; patient must be able to swallow entreat medications with no requirement for a feeding tube; patient’s must not have intractable nausea or vomiting which prohibits the patient from oral medications
Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included
Patient must be able to tolerate oral medication
Inability to take oral medications
Able to take oral medications
Ability to receive oral medication
Able to tolerate oral therapy.
Able to take oral medications
Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following:
Active dental or jaw condition which requires oral surgery
Non-healed dental/oral surgery
Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications.
Must be able to take oral medication without crushing, dissolving or chewing tablets
Use of any of the following after transplantation and prior to starting oral Azacitidine:
Inability to swallow oral medication or condition that could interfere with oral absorption or tolerance of treatment
Subjects must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration
Patients must be able to take oral medications
Subjects must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration.
Serum potassium greater than 3.5 mmol/L without oral supplementation
Ability to take oral medications and willing to record daily adherance to investigational product
Ability to take oral medication.
Ability to take oral medications (capsule must be swallowed with liquid)
Patients must be able to consume oral medications
Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
Ability to tolerate oral medications.
Known active infection requiring intravenous (IV) or oral anti-infective treatment
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow, retain, and/or absorb the drug are excluded
Any condition that impairs ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease)
Patients must be able to take oral medication.
Able to take oral medications
Inability to tolerate or absorb an oral medication due to any cause, including but not limited to malabsorption syndromes
Patients who are unable to take oral drugs
According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration; these guidelines may change pending results from an ongoing food effects study
Inability to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel
Inability to swallow oral medications (unless patients use a feeding tube in which case they are eligible)
Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin
Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
For subjects assigned to take vorinostat, inability to take oral medications; vorinostat capsules must be administered whole; note: this criterion does NOT apply to subjects treated on the Expansion Cohort (accruals post February 1, 2013)
Participants in whom the required program of oral (PO) and IV fluid hydration is contraindicated
Can take oral med
Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of Itraconazole (anti-convulsants, corticosteroids)
Active dental or jaw condition which requires oral surgery
Non-healed dental/oral surgery
Received therapeutic oral or IV antibiotics within 4 weeks prior to Cycle 1, Day 1 (except for tumor fever)
Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.
Has had prior hormonal therapy such as Lupron or oral anti-androgens
Any underlying condition that would significantly interfere with the absorption of an oral medication
Able to take oral medications
Oral, implantable, or injectable hormone contraceptives are not considered effective for this study
Patient received previous treatment with oral AC480
Oral or transdermal estrogen therapy is not allowed
Current oral steroid use > 2 weeks prior to registration
Subjects with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow and retain enzalutamide are excluded
Ability to take oral medication;
Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
Are using oral hormonal contraceptives and who do not agree to add a barrier method
Adult patients with a cancer diagnosis receiving oral or intravenous (IV) chemotherapy at Dana-Farber on Yawkey 10
Patients unable to tolerate oral intake by mouth or per enteral feeding tube
About to begin either oral or cytotoxic chemotherapy
Patients not able to swallow oral medications or with gastrointestinal conditions that may impact absorption of oral medications
Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
Patient receiving active intravenous, intraperitoneal or oral chemotherapy
Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
Current use of corticosteroids defined as oral, intravenous (IV), or injections of corticosteroids in the past 4 weeks\r\n* If the patient is only prescribed a short-term, time-limited dose of oral, intravenous (IV), or injections of corticosteroids, then they may be rescreened for eligibility once they are >= 4 weeks post-completion of their course of corticosteroids
Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Inability to tolerate preoperative oral intake
Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), or androgens during the previous 3 months
Patients with epilepsy requiring permanent oral medication
Active infectious disease excluding oral candidiasis
Presence of oral mucositis (WHO Score ? Grade 1) at study entry
Inability to tolerate oral or enteral medication
Starting a new treatment regimen that includes a single oral anticancer medication
Grade 2 or higher oral mucositis
Has taken oral immediate release opioids within 4 hours prior to arrival
At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment; Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication; the patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4
No current diagnosed untreated or unresolved oral candidiasis or oral herpes simplex virus (HSV) infection
Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
Diagnosis of cancer with an active prescription for oral chemotherapy
Individuals who are enrolled on oral chemotherapy clinical trials will also be excluded
Baseline presence of oral ulcers
Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
Patients must have begun postoperative oral intake of food prior to registration
Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
Use of oral bisphosphonates with a cumulative exposure of more than 1 year
Active dental or jaw condition which requires oral surgery, including tooth extraction
Non-healed dental/oral surgery, including tooth extraction
Be able to tolerate topical application of phenylephrine to the oral mucosa
Open or unhealed wounds or ulcers in the oral cavity
Primary or secondary tumor in the oral cavity
Able to tolerate oral medication
Has active infectious disease undergoing systemic treatment excluding oral candidiasis
Patient participating in another biomedical/oral health interventional research study
Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes
Active infectious disease excluding oral candidiasis
Presence of oral mucositis at study entry
Participant is able and willing to take oral medications
Clinical diagnosis of BRONJ subsequent to oral surgery as established by standard clinical protocol per American Association of Oral and Maxillofacial Surgeons (AAOMS) diagnostic criteria
At least one third of the oral cavity mucosa must be included in the RT fields, as estimated by the treating radiation oncologist
Current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis
Patients declining oral biopsies
Must be able to take oral medication without crushing, dissolving or chewing tablets
Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
Concomitant use of oral cyclosporine
Have a known history of inability to absorb an oral agent
Reported use of oral antidiabetic agents (OADs).
Subjects will be eligible if their planned post grafting immunosuppression consists of one of the two following regimens:\r\n* TAC/MTX: tacrolimus (oral or intravenous) and intravenous methotrexate administered according to institutional standard practice.\r\n* TAC/SRL: tacrolimus (oral or intravenous) and oral sirolimus, administered according to institutional standards of care
Patients must be able to take oral medications, although a brief period of IV therapy (< 4 days) is permitted at trial entry
Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasites, anti-virals
Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with nasogastric (NG)-tube, jejunostomy feeding (J)-tube, or gastrostomy (G)-tube will not be allowed to participate
Patient unable to sit up or stay up for 30 minutes after taking oral dose
Willingness to take oral medications during the transplantation period
Must be able to tolerate routine oral voriconazole, posaconazole or isavuconazole as fungal prophylaxis therapy
Have history of oral cancer or carcinoma in-situ
Require antibiotic therapy prior to oral cleaning
Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
Prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, evidence of untreated local gum or oral infection, or non-healed dental or oral surgery
Active dental or jaw conditions which require oral surgery/dental procedures, including tooth extraction within 6 months of the study
Patients on systemic corticosteroids (oral or intravenous)
Ability to take oral medication
Oral carcinoma in situ
Any oral steroid use within 2 weeks of testing
Treatment with other oral hypoglycemic agents
Stable hormone status for 8 weeks prior to aspiration and willing to maintain same status while on study; this means no change in an oral or non-oral hormonal contraceptive within the past 8 weeks prior to RPFNA
Patients with gross tumor involvement of the oral cavity or oral mucosa
Patients enrolled on another investigational trial for oral mucositis prevention
Participants with known inability to adequately absorb oral medication
Any use of oral corticosteroids =< 12 weeks prior to registration/randomization
Prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative at any time in the subject's prior history
Patients must be able to take oral medications without crushing, dissolving or chewing tablets
Unable to receive medications oral medications
Any participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide or obtain institutional commitment from the study site to provide temozolomide
Receipt of therapeutic oral or IV antibiotics within 2 weeks of first study treatment; subjects receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible
Histological/cytological confirmation of oral cavity dysplasia or prior history of OSCC
Are willing to refrain from using other treatments for oral mucositis until they consult with the study investigator(s).
Have a known history of inability to absorb an oral agent
Patients who currently have stomatitis/oral mucositis/mouth ulcers;
able to perform oral rinse
Oral ketoconazole or other azole antifungals
Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
No intravenous (IV) or oral contrast medium within the week prior to enrollment
Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head & neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible
Subject has oral lesion
Subject with normal oral tissue
Diseases of the soft or hard oral tissues
Patients currently using oral bisphosphonate therapy
2 weeks since any oral anti-neoplastic or oral investigational agent
Known active infection requiring parenteral or oral anti-infective treatment within defined period
NORMAL GROUP: If subject is presently using oral contraceptives at the beginning of the study, does not plan to stop oral contraceptive use for the duration of the study
NORMAL GROUP: If subject is not using oral contraceptives at the beginning of the study, does not plan to begin oral contraceptive use during the duration of the study
Persons presenting for: physical or dental exams at outside health care centers OR research meetings/gatherings OR subjects identified at MD Anderson Cancer Center (MDACC) who are not already diagnosed with oral cancer or pre oral cancer: this includes patients with malignancies other than oral cancer, and visitors and family members, attendees of the National Health Service (HNS) Oral Cancer Screening event who are willing to participate
Subjects with a current diagnosis of oral cancer
Inability to take oral medication, or presence of a malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability of H3B-6527. Participants with prior gastric resection are eligible
Received oral or IV antibiotics within 14 days prior to Day 1
Be scheduled to receive at least 6 weeks (i.e. at least 2 cycles) of oral or intravenous (IV) chemotherapy during the study intervention period; therapeutic clinical trial participants are allowed
Must be able to perform oral rinse
physiologic condition that precludes the use of an oral rinse
Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (? 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.
Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
Uncontrolled asthma or asthma requiring oral corticosteroids.