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Assess the Oral Bioavailability of New ABT-263 Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743028
First Posted: August 28, 2008
Last Update Posted: October 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by:
Abbott
  Purpose
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia Lymphomas Leukemias Drug: ABT-263 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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. [ Time Frame: 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). [ Time Frame: Three Period crossover design. ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Two and three period crossover design ]

Enrollment: 36
Study Start Date: August 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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
Experimental: 2 Drug: 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
Experimental: 3 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.
Experimental: 4 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.
Experimental: 5 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.
Experimental: 6 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743028


Locations
United States, California
Site Reference ID/Investigator# 10281
Encinitas, California, United States, 92024
Site Reference ID/Investigator# 10282
Santa Monica, California, United States, 90404
United States, Maryland
Site Reference ID/Investigator# 16341
Bethesda, Maryland, United States, 20892
United States, New Hampshire
Site Reference ID/Investigator# 9441
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Site Reference ID/Investigator# 20041
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Abbott
Genentech, Inc.
  More Information

Responsible Party: Andrew Krivoshik, MD, PhD, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00743028     History of Changes
Obsolete Identifiers: NCT00923689
Other Study ID Numbers: M10-454
First Submitted: August 26, 2008
First Posted: August 28, 2008
Last Update Posted: October 7, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Other hematological and non-hematological malignancies

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Navitoclax
Antineoplastic Agents