Assess the Oral Bioavailability of New ABT-263 Formulations

NCT00743028 | Completed Phase 1

• 1 other identifier: M10-454
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

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

Keywords

Other hematological and non-hematological malignancies

Outcome Measures

Primary Outcomes (2)

• 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.

  Two Period crossover design.

• 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 and assess new ABT-263 formulations after once daily dosing (QD) and twice daily dosing (BID).

  Three Period crossover design.

Secondary Outcomes (1)

• Safety measures include number and percentage of subjects having treatment-emergent adverse events tabulated by MedDRA system organ class and preferred term, laboratory test results, lymphocyte enumeration results, vital signs, etc.

  Two and three period crossover design

Study Arms (6)

1

EXPERIMENTAL

Drug: ABT-263

2

EXPERIMENTAL

Drug: ABT-263

3

EXPERIMENTAL

Drug: ABT-263

4

EXPERIMENTAL

Drug: ABT-263

5

EXPERIMENTAL

Drug: ABT-263

6

EXPERIMENTAL

Drug: ABT-263

Interventions

ABT-263 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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead
• Genentech, Inc.: collaborator

Study Sites (5)

Site Reference ID/Investigator# 10281

Encinitas, California, 92024, United States

Location

Site Reference ID/Investigator# 10282

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 16341

Bethesda, Maryland, 20892, United States

Location

Site Reference ID/Investigator# 9441

Lebanon, New Hampshire, 03756, United States

Location

Site Reference ID/Investigator# 20041

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Leukemia

Interventions

navitoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Last Updated: October 7, 2010

Record last verified: 2010-09

Locations

US (5)