Phase I/II: Patients must have received ? 2 units of RBCs for hemoglobin ? 9.0 g/dL within 8 weeks prior to start of treatment.
Phase II only: Patients with a deletion 5q cytogenetic abnormality.
ELIGIBILITY CRITERIA - PHASE II (ARM D): ECOG performance status 0-2
RANDOMIZED PHASE II CLINICAL TRIAL: Disease stage IV, metastatic unresectable disease
RANDOMIZED PHASE II CLINICAL TRIAL: Patients received up to 2 prior regimens for their metastatic disease
RANDOMIZED PHASE II CLINICAL TRIAL: Patients are candidates for chemotherapy with carboplatin and gemcitabine
RANDOMIZED PHASE II CLINICAL TRIAL: ECOG performance status 0-2
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: Platelets >= 100,000 / mcL
RANDOMIZED PHASE II CLINICAL TRIAL: Patients with tumors that cannot be measured or clinically followed (i.e. evaluable disease)
RANDOMIZED PHASE II CLINICAL TRIAL: Patients with baseline grade 2 neuropathy
RANDOMIZED PHASE II CLINICAL TRIAL: Life expectancy of less than 3 months
RANDOMIZED PHASE II CLINICAL TRIAL: Patients known to be carriers of hepatitis virus B and C
RANDOMIZED PHASE II CLINICAL TRIAL: Active infection requiring systemic therapy
PHASE II: Patients must have received at least one prior chemotherapy or radiation regimen prior to radiographic progression
PHASE II: Tumor must be measurable in at least two dimensions on imaging
PHASE II EXCLUSION CRITERIA: Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study
PHASE II EXCLUSION CRITERIA: Untreated and uncontrolled second tumor in the past 2 years
PHASE II EXCLUSION CRITERIA: Logistical or psychological hindrance to participation in clinical research
Phase II only: Measurable disease according to RECIST v1.1 (Section 8) obtained by imaging within 28 days prior to study registration. Phase Ib: subjects may enroll with or without measurable disease.
Phase I Extension and Phase II: Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
Phase I extension and Phase II only: Prior treatment with a hypomethylating agent, such as prior treatment for MDS.
PHASE II: Patients must have received at least one prior chemotherapy or radiation regimen prior to progression
PHASE II: At least 3 months must have elapsed since the last dose of irradiation to the target tumor(s) at the time of enrollment
PHASE II
PHASE I AND II
FOR PHASE II PORTION OF THE STUDY:
FOR PHASE II ONLY:
PHASE II: ECOG performance status =< 2
Metastatic renal cell carcinoma\r\n* During Phase I - All prior treatments or none are allowed\r\n* During Phase II/Cohort A - No prior treatments are allowed\r\n* During Phase II/Cohort B - Must have at least one prior treatment with a PD1 inhibitor
Phase II only: blood EGF level >= pg/mL at baseline (to be determined based on Phase I results)
No more than two prior disease relapses to be eligible for the phase I portion of the study and no more than one prior relapse to be eligible for phase II
Evaluable disease in the phase I, and measurable disease for the phase II study
Central nervous system metastases, including lymphomatous meningitis will be allowed in the phase II study, but will not be allowed in the phase I
PHASE II: Patients must have an ECOG performance status of 0-1
PHASE II: Hemoglobin >= 9.0 g/dl
Prior chemotherapies more than 2 lines (Phase II part only) .
PHASE II SCLC: ECOG performance status =< 2
Randomized phase II: tumor proportional score of PD-L1 >= 1%.
PHASE II: Platelets > 100,000/mcl
PHASE II: Hemoglobin > 10 g/dL
PHASE II: Creatinine < 1.5 x the institutional ULN
PHASE II: Bilirubin < 1.5 x ULN
PHASE II: ALP < 2.5 x ULN
PHASE II: Patients must meet pre-entry requirements as specified
PHASE II: Patients who have previously received anti-CTLA-4 antibody therapy
Phase II only: patients volunteering for the Phase II part of the protocol must be willing to undergo a research endoscopy for tissue collection on day 8 (+/- 2 days) from the beginning of therapy
PHASE II: Patients may only have measurable disease
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
BOTH PHASE I AND PHASE II:
PHASE II:
Phase II: 0, 1 or 2
RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2
RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
For Phase II only: Patients must have evidence of FLT3 ITD in their most recent assessment.
For Phase I and II: ECOG Performance Status </= 2
Disease status: phase I: patients with refractory solid tumors must have evaluable disease, patients with NF1 PN must have measurable disease, patients with refractory leukemia must have M2 or M3 bone marrow; phase II: patients must have measurable disease; phase II temporarily suspended as requested by the FDA due to IND Safety Report of 07 October 2016
Individuals with malignant peripheral nerve sheath tumors will not be eligible to participate in the phase II portion of the trial
An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:\r\n* Measurable disease is defined as the presence of at least one solid lesion on MRI or CT scan that can be accurately measured with the longest diameter of at least 10 mm in at least one dimension\r\n* Patients with NB who do not have measurable soft tissue disease but have MIBG-positive evaluable skeletal disease are eligible for phase II study\r\n* Patients with NB who have evidence of tumor cells in bone marrow are eligible for phase II study
PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer
For phase II part of the trial: =< 3 prior lines of treatment in the metastatic setting for the current breast cancer; however, there is no limit on number of prior line of therapy in phase I part of the trial
RANDOMIZED PHASE II STUDY -- ARMS C AND D
PHASE II: Patients must NOT have locally advanced disease
PHASE II: Patients must NOT have received prior Wee1 inhibitors or AZD1775
PHASE II: Patients must have ECOG performance status of 0 or 1
PHASE II: Patients with biliary stents are allowed
PHASE II: Hemoglobin >= 9 g/dL
PHASE II: Platelets >= 100,000/mcL
PHASE II: The patient has consented in writing to participate in one of the imaging research studies
PHASE II:
PHASE I AND II:
PHASE II: ECOG performance status 0 or 1
PHASE II: Platelets >= 100,000/mm^3
PHASE II: Hemoglobin >= 9 g/dL
Subjects enrolled in phase II part of the protocol should not have metastatic disease; however, patients with oligometastatic disease that can be treated with localized treatment with definitive intent are eligible
Phase II only: at least one line of prior therapy for incurable disease
At least a single measurable lesion. Phase II patients only
Phase I (Cohorts A through S) and Phase II: Evaluable or measurable disease per RECIST version 1.1
For expansion phase (Phase II) distant metastatic disease only.
For expansion phase (Phase II) no prior therapy for pancreatic cancer is allowed except for adjuvant therapy as long as it was completed ? 6 months prior to study treatment start
Patients with RAEB-t/non-proliferative AML (as defined by 20-30% BMBL, WBC ? 25,000 x 10^9/L and stable for at least 4 weeks without intervention) are not eligible to participate in the Phase II Part 1 RPTD component of the study and patients with CMML will not be eligible for Phase II Part 2 of the study.
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies for the treatment of prostate cancer
Only for patients entering phase Ib dose escalation and phase II cohorts:
For Phase II part:
PHASE II: GCSF is allowed during screening and therapy for all phase II patients
PHASE II: ECOG performance status =< 1
PHASE II: Platelets >= 100,000/mcL
PHASE II: Patients with evidence of metastatic disease involvement in viscera or bone
PHASE II: Clinically significant malabsorption syndrome
PHASE II: Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as antineoplastic therapy
Evaluable disease in the Phase I, and measurable disease for the Phase II
Participants who previously received eribulin mesylate are not eligible for enrollment on the phase II portion
PHASE II PORTION ELIGIBILITY CRITERIA
PHASE II:
PHASE I and II:
PHASE II
PHASE I and II
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
For Phase Ib: patients with HER2 overexpressing disease must have been previously treated with trastuzumab (patients with HER2 overexpressing disease are not eligible for the Phase II trial)
In phase II study (PMLBL) patients with CNS involvement are not eligible
Non-secretory or oligo-secretory Multiple Myeloma (Phase II only; such disease is permissible in Phase I).
Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies
Concurrent tumor-specific hormonal therapy or antiestrogens. (Individuals manufactured under CL-PTL 105 (Phase II Ovarian) are not subject to this exclusion).
For participation in the Phase II portion, patients must have completed at least one line of prior therapy
A core tumor biopsy obtained after progression on the last treatment must be available at study entry for the phase II portion of the study; any available archival tissue (for both phase I and II) will also be collected
Patients with ECOG performance status of 2, secondary to the underlying disease, may be enrolled in the Phase II portion of the study
For Phase II, patients may have received a maximum of 1 prior line of therapy for recurrent or metastatic disease
Patients with swallowing dysfunction who are unable to swallow BYL719 whole tablets and are not using feeding tubes for study drug administration can participate in the Phase Ib Arm B. For the Phase II, these patients with swallowing dysfunction may participate if able to drink the suspension and results of Arm B confirm the use of this method. Patients with swallowing dysfunction requiring G tube (G/PEG tube) for study drug administration may participate in Phase II if Arm C confirms dispersible tablet via G tube administration is permitted if the administration of drinkable suspension of BYL719 is allowed to be used in Phase II.
For patients in the Phase II portion of the study, must have measurable disease defined by at least 1 of the following 3 measurements:
PHASE II SPECIFIC:
Measurable disease (only for the phase II portion)
No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only).
Prior hypersensitivity to triptan derivatives (Phase I and II)
PHASE II: All patients will be required to have measurable disease
During Phase II enrollment: prior therapy with cisplatin with the exception of when given concurrently with radiation therapy (cisplatin will be allowed as prior therapy during Phase I enrollment)
No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
Male or female for phase I and female for phase II and any race
Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
PHASE II: Completed primary surgery, chemotherapy, and radiation
PHASE II: Within 12 months of beginning AET
PHASE II: At least 18 months of AET recommended
PHASE II: Any diagnosis of cancer prior to age 21
PHASE II: Off treatment for at least 6 months
PHASE II: Significant developmental delay per patient, parent, or physician report
COHORT A OVERVIEW: patients age less than 60 with untreated stage III or IV classical Hodgkin lymphoma will be eligible for cohort A; in phase I, patients may enroll onto cohort A if they have a baseline IPS ? 3 OR if their PET scan after 2 cycles of ABVD is positive (Deauville 4 or 5); enrollment onto phase I has now ceased and enrollment will begin for phase II; in phase II, patients less than 60 years of age with stage III or IV HL are eligible; patients may enroll anytime within the first 2 cycles of ABVD or after PET-2
Phase II: Not completing participation in phase I of the study
Phase II: Myeloma diagnosis
Phase II: From 3–24 months post-surgical treatment
Cancer survivors will be partnered, cohabiting women with a diagnosis of non-metastatic breast cancer (stages I-III), and a body mass index (BMI) >= 30 who are healthy enough to participate in a home-based walking program (per medical provider clearance; Phase I, part B and Phase II only)
Survivors will have completed adjuvant chemotherapy and/or radiation treatment, with those participating in phase I within 5 years of completing treatment and those participating in phase II within three years (36 months) of completing treatment
Partners will be cohabiting with the cancer survivor and have a BMI >= 25, be healthy enough to participate in a home-based walking program (per medical provider clearance; Phase I, part B and Phase II only)
EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II)
PHASE II: Did not participate in phase 1
Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
Phase II: Self-identify as Hispanic/Latino
Phase II: Prefer to receive health information in Spanish
Phase II: Only patients who are not up-to-date with screening and are attending regularly scheduled clinic visits will participate
PHASE II: Use of IT at least 25 times in the past year
Completed the 1-year phase II low-fat fish oil study
Phase II:
PHASE II:
PHASE II: Women who do not have capacity to participate
PHASE II: women who state that there are still deciding on breast cancer treatment
PHASE II: Pregnant women will be eligible to participate
For phase II only: Patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part of the trial).