A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01021358
First received: November 25, 2009
Last updated: December 16, 2010
Last verified: December 2010

November 25, 2009
December 16, 2010
January 2010
October 2010   (final data collection date for primary outcome measure)
To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021358 on ClinicalTrials.gov Archive Site
To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients. [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)

This is a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Chronic Lymphocytic Leukemia
  • Solid Tumors
  • Drug: ABT-263
    Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
    Other Name: ABT-263
  • Drug: Ketoconazole
    Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
    Other Name: Ketoconazole
Experimental: Arm A (ABT-263 and Ketoconozole)
Interventions:
  • Drug: ABT-263
  • Drug: Ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older.
  • Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.
  • In the investigator's opinion, the subject's 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 first dose of study drug.
  • Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.

Exclusion Criteria:

  • History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
  • Has undergone an allogeneic stem cell transplant.
  • Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
  • Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Female subject is pregnant or breast-feeding.
  • History of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc).
  • Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration.
  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer
  • Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function.
  • Currently receiving or requires anti-fungal treatment or CYP3A inhibitors. In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT-263.
  • History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021358
M10-957
No
Andrew Krivoshiik, MD, PhD, Medical Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
December 2010

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