Assess the Oral Bioavailability of New ABT-263 Formulations

NCT ID: NCT00743028

Last Updated: 2010-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia; Lymphomas; Leukemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation

2

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation

3

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

4

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

5

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

6

Group Type: EXPERIMENTAL

ABT-263

Intervention Type: DRUG

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

Interventions

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation

Intervention Type: DRUG

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

Intervention Type: DRUG

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

Intervention Type: DRUG

Eligibility Criteria

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/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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Locations

Site Reference ID/Investigator# 10281

Encinitas, California, United States

Site Reference ID/Investigator# 10282

Santa Monica, California, United States

Site Reference ID/Investigator# 16341

Bethesda, Maryland, United States

Site Reference ID/Investigator# 9441

Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 20041

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

M10-454

Identifier Type: -

Identifier Source: org_study_id

NCT00923689

Identifier Type: -

Identifier Source: nct_alias