Assess the Oral Bioavailability of New ABT-263 Formulations

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00743028
First received: August 26, 2008
Last updated: October 6, 2010
Last verified: September 2010

August 26, 2008
October 6, 2010
August 2008
August 2010   (final data collection date for primary 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. [ Time Frame: Two Period crossover design. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Assess the bioavailability of a capsule formulation of ABT-263 relative to that of the current liquid formulation of ABT-263 in subjects with cancer. [ Time Frame: Two-sequence, two-regimen crossover design. ] [ Designated as safety issue: No ]
  • Assess the safety of ABT-263 [ Time Frame: Two-sequence, two-regimen crossover design. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00743028 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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Assess the Oral Bioavailability of New ABT-263 Formulations
A Single Dose Study Evaluating the Oral Bioavailability and Pharmacokinetics of the Capsule Formulation of ABT-263 in Subjects With Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Lymphomas
  • Leukemias
  • 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
    Other Name: ABT-263
  • 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: 1
    Intervention: Drug: ABT-263
  • Experimental: 2
    Intervention: Drug: ABT-263
  • Experimental: 3
    Intervention: Drug: ABT-263
  • Experimental: 4
    Intervention: Drug: ABT-263
  • Experimental: 5
    Intervention: Drug: ABT-263
  • Experimental: 6
    Intervention: Drug: ABT-263
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743028
M10-454
Not Provided
Andrew Krivoshik, MD, PhD, Medical Director, Abbott
Abbott
Genentech, Inc.
Not Provided
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP