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A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Lymphomas, Leukemias

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Trial Information

A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer


Inclusion Criteria:



- > or =18 years of age;

- 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;

- Life expectancy is at least 90 days;

- 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;

- ECOG performance score of < or = 1;

- Adequate bone marrow, renal and hepatic function per local laboratory reference range
as follows:

- ANC > or = 1,000/┬Ál;

- Platelets > or = 100,000/mm3;

- Hemoglobin > or = 9.0 g/dL;

- serum creatinine < or = 2.0 mg/dL or calculated creatinine clearance > or = 50;

- 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;

- aPTT, PT not to exceed 1.2 x ULN;

- Females must be surgically sterile, postmenopausal, have negative pregnancy test at
screening;

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies.

Outcome Time Frame:

Two Period crossover design.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

M10-454

NCT ID:

NCT00743028

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lymphomas
  • Leukemias
  • Other hematological and non-hematological malignancies
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Site Reference ID/Investigator# 10281 Encinitas, California  92024
Site Reference ID/Investigator# 10282 Santa Monica, California  90404
Site Reference ID/Investigator# 16341 Bethesda, Maryland  20892
Site Reference ID/Investigator# 9441 Lebanon, New Hampshire  03756
Site Reference ID/Investigator# 20041 Hackensack, New Jersey  07601