Assess the Oral Bioavailability of New ABT-263 Formulations
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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> or =18 years of age;
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Non-hematologic malignancy or hematologic malignancy that is either relapsed or refractory to standard therapy, or failed up to 5 prior standard therapies or no know effective therapy exists;
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Life expectancy is at least 90 days;
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If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the 1st dose of study drug;
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ECOG performance score of < or = 1;
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Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
- ANC > or = 1,000/µl;
- Platelets > or = 100,000/mm3;
- Hemoglobin > or = 9.0 g/dL;
- serum creatinine < or = 2.0 mg/dL or calculated creatinine clearance > or = 50;
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AST and ALT < or = 3.0 x ULN; Bilirubin < or = 1.5 x ULN. Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN;
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aPTT, PT not to exceed 1.2 x ULN;
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Females must be surgically sterile, postmenopausal, have negative pregnancy test at screening;
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Females not surgically sterile or postmenopausal & non-vasectomized males must practice at least one of the following methods of birth control:
- Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to starting study drug);
- Vasectomized partner;
- Hormonal contraceptives for at least 3 months prior to study;
- Double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
Exclusion criteria
- History of/clinically suspicious for cancer-related CNS disease; An allogeneic stem cell transplant.
- Underlying, predisposing condition of bleeding/currently exhibits signs of bleeding.
- History of non-chemotherapy induced thrombocytopenic associated bleeding w/i 1 year prior to the 1st dose.
- Peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- Active ITP/ history of being refractory to platelet transfusions.
- Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic/hepatic disease.
- Females pregnant or breast-feeding.
- History of or active medical condition(s) that affects absorption or motility.
- Positive for HIV.
- Other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; neutropenic fever w/i 1 wk prior to study drug.
- Steroid therapy w/i 7 days prior to 1st dose for anti-cancer intent.
- Anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (except hormones for hypothyroidism or ERT)/agonists required to suppress serum testosterone levels [e.g. LHRH, GnRH], any investigational therapy w/i 14 days prior to first dose of study drug.
- Biologic agent w/i 30 days prior to 1st dose.
- Anticoagulation therapy/drugs/herbal supplements affecting platelet function.
- Aspirin w/i 7 days prior to 1st dose.
- Grapefruit/grapefruit products.
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 6 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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