A guidance regarding potential interactions with concomitant medications is provided
Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
Use of protocol-defined prior/concomitant therapy.
Anticipated use of any concomitant medication during or within 7 days before initiation of study treatment that is known to cause QT prolongation
Requirement for concomitant therapy or food that is prohibited during the study
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
Concomitant medication restrictions:
Concomitant medication restrictions
Concomitant medications with another A1R antagonist that would increase the risk of seizure (e.g., theophylline, aminophylline).
concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
Concomitant diseases/conditions:
Uncontrolled concomitant disease
Concomitant second malignancies
EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
Previous and concomitant therapy that precludes enrollment, as defined in the protocol
Concomitant use of the strong CYP2C8 inhibitors gemfibrozil or trimethoprim (Bactrim)
Concomitant treatment with other anti-neoplastic agents, with the exception, when clinically indicated, of prophylaxis in the post-transplantation setting with intrathecal chemotherapy
Concomitant medications: drugs that are considered category D (consider therapy modification) and X (avoid combination) using the Lexicomp database are prohibited; concomitant drugs that fall into categories A (no known interaction), B (no action needed) and C (monitor therapy) are allowed
Subjects with concomitant second malignancies
Have a serious concomitant systemic disorder.
Use of protocol-defined prior/concomitant therapy.
Any of the following concomitant diseases/conditions:
Patients receiving any concomitant systemic therapy for renal cell cancer are excluded.
Concomitant Medications:
Uncontrolled concomitant disease
Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment.
Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy or other novel agent) or live virus and live bacterial vaccines while the patient is receiving study medication. Strong or moderate CYP3A inhibitors and inducers should not be taken with study treatment; however, if no other suitable alternative concomitant medication is available, dose reductions may be allowed under careful monitoring
Uncontrolled concomitant disease
Serious concomitant systemic disorder.
Concomitant use of other cytotoxic or cytostatic drugs other than PTX
Patients receiving any concomitant systemic therapy for renal cell cancer are excluded
Have a serious concomitant systemic disorder.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
There are currently no known concomitant medications that must be discontinued prior to administration of registration on study and for the duration of sEphB4-HSA
Currently on the following concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study drug(s); the use of the following medications should be discontinued prior to initiation of protocol therapy and should be avoided during protocol therapy if reasonable alternatives exist\r\n* Erlotinib\r\n* Temozolomide
Concomitant use of any anti-cancer therapy or immune modifier.
Uncontrolled concomitant disease
Concomitant therapies for treatment or control of leukemia.
Concomitant medications:
Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Other serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Concomitant use of bisphosphonates or RANK-ligand inhibitors is allowed
Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Concomitant medications, if taken within the last 28 days
Concomitant use of bisphosphonates is allowed
Concomitant medications:
Prior or concomitant systemic anti-cancer treatment for advanced disease
Enrollment in a concomitant clinical study
Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
Concomitant use of medications associated with a high incidence of QT prolongation
Any condition which could jeopardise the safety of the patient and his/her compliance in the study Excluded therapies and medications, previous and concomitant:
Must not require concomitant treatment with anticoagulants
Requirement for any non-study potentially effective concomitant systemic antibacterial therapy
Concomitant use of drugs known to cause QT prolongation (Note: Ondansetron at doses ? 16 mg or less is allowed)
Concomitant radiotherapy
Presence of any serious or unstable concomitant systemic disorder incompatible with\n             the clinical study
No concomitant use of alternative complimentary therapies or over the counter (OTC) agents allowed without prior approval of the principal investigator (PI)
Have, at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only; Ta/T1 high-grade disease with concomitant CIS; or Ta/T1 high-grade disease without concomitant CIS
Prior/Concomitant Therapy
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Use of protocol-defined prior/concomitant therapy.
Other concomitant malignancies (with some exceptions per protocol)
Other concomitant malignancies (with some exceptions per protocol)
Any concomitant systemic therapy or radiation therapy initiated for this malignancy.
Life expectancy severely limited by concomitant illness or uncontrolled infection
Evidence of any significant, uncontrolled concomitant disease
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
No concomitant approved anti-cancer therapies or any investigational agents
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Concomitant diseases/conditions:
Concomitant treatment with:
No planned concomitant, non-protocol directed anti-cancer therapy
Have clinical evidence of concomitant infectious conditions.
Concomitant medications causing prolonged QT which cannot be discontinued or changed to a different medication prior to initiating study
Concomitant use of antithrombotic agents with the exception of platelet inhibitors.
Concomitant malignancies
Patients must be able to follow concomitant medication restrictions:
Previous or concomitant malignancies at any other site with the exception of the following:
Evidence of significant, uncontrolled concomitant disease
Is receiving concomitant treatment with drugs that may interact with capecitabine
Patients requiring concomitant medications that are not able to be switched to a reasonable alternative
Patients must not receive concomitant radiation
Have a serious concomitant systemic disorder or significant cardiac disease.
Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
Concomitant use of additional anti-neoplastic agents will not be allowed in this study
Participants may not be receiving any other investigational agents for 30 days prior to baseline evaluation and during the study intervention (which will be captured on the Concomitant Medications CRFs)
Concomitant therapy with immune-suppressants or chronic use of systemic corticosteroids
There must be no plans to receive concomitant chemotherapy, biological response modifiers, radiation therapy or hormonal therapy; concomitant radiation therapy is allowed for the palliation of severe pain/neuropathic compression
Prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed
Concomitant use of medications that may alter pharmacokinetics of enzalutamide
EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
Excluded therapies and medications, previous and concomitant:
Concomitant therapy that precludes enrollment, as defined in the protocol
Patients with concomitant disease know to get influence on bone metabolism
Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
Concomitant Medication and Treatment: \r\n* All allowed medications or treatments should be kept to a minimum and recorded; all questions regarding concomitant medications should be referred to the Investigator
Any other concomitant anti-cancer treatment.
Concomitant therapy with bisphosphonates is allowed
Serious concomitant systemic disorder
Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
Concomitant medications should be avoided (when possible) while on study
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol; concomitant use of corticosteroids is permitted as clinically indicated
Concomitant use of bisphosphonates is allowed
Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
Concomitant malignancy;
Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Serious concomitant conditions
Has a condition that requires the concomitant use of any of the protocol-excluded medications, supplements, or food products during the course of the study .
Concomitant treatment with chemotherapeutic agents for diseases other than malignancy
Participants who take medications that are not recommended for concomitant use with their current antiretroviral regimen
Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
Subject requires the use of the following concomitant treatments/procedures at any time, per protocol.
Concomitant use of phosphodiesterase inhibitors
Received concomitant Temozolomide
Concomitant CRT completed prior to randomisation
Patients who are receiving concomitant systemic therapy for breast cancer
Patients receiving concomitant radiotherapy or immunotherapy
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Other concomitant anti-tumor therapy as determined by the study team.
Concomitant diseases/conditions
Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
Serious concomitant systemic disorders
Other concomitant malignancies (with some exceptions per protocol)
Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
Concomitant chemotherapy or radiotherapy is not permitted.
Other concomitant malignancies (with some exceptions per protocol)
Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment.
Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this study
Other active concomitant malignancy that warrants systemic therapy
Other active concomitant malignancy that warrants systemic therapy
Patients who are on concomitant treatment with drugs that are contraindicated in this study and that cannot be discontinued within the time frames
Concomitant medications that are known inducers of CYP.
For patients enrolled into Stage I, they must have received at least 75% of planned radiotherapy (60 Gy) with temozolomide treatment during the concomitant phase have documentation that the patient's absolute neutrophil count (ANC) is ? 1.5 x 109/L, platelet count is ? 100 x 109/L, and there was no CTC grade 2 or above nonhematological toxicity (except for alopecia, nausea, vomiting) during the concomitant phase treatment be within ? 4 weeks but ? 6 weeks following the completion of temozolomide in the concomitant phase
Concomitant chemotherapy or radiotherapy is not permitted.
The patient has (or has had) previous or concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
Concomitant enrollment in a Phase I study
Presence of previous or concomitant neoplasm with exclusion of in situ cervical cancer
NOTE: concomitant treatment with ongoing trastuzumab (Herceptin) or other targeted/biologic agents is allowed; concomitant treatment with any other type of chemotherapy or hormonal therapy is not allowed
Concomitant use of medications that may alter pharmacokinetics of abiraterone or apalutamide
Concomitant malignancies
Subjects with chronic kidney disease or concomitant parathyroid disease
No other concomitant therapy directed at the cancer is allowed
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ? 5 mg daily.
Concomitant panniculectomy or plastic surgery
Concomitant use of medications known to induce a disulfiram-like reaction to alcohol
No exclusion is necessary based on the use of other concomitant medications; specifically there is no prohibition of concomitant antibiotic, antiviral or antifungal therapy; subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
Concomitant biologic, hormonal, or radiation therapy are acceptable
Severe concomitant illnesses
Concomitant use of oral cyclosporine
Women who are receiving any other concomitant treatment for their DCIS/ADH
Concomitant corticosteroids or anticoagulants needed on a regular or predictable intermittent basis
Severe concomitant illnesses
Concomitant investigational therapy
Concomitant investigational therapy
No concomitant infection or other serious major systemic illness
Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use
Other concomitant malignancies (with some exceptions per protocol)
Concomitant diseases/conditions:
Concomitant medications:
Co-medication or concomitant therapy that may interfere with study results
Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry.
Patients required to be on any of the concomitant medications are excluded