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

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.
ClinicalTrials.gov Identifier: NCT01021358
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : December 20, 2010
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma Chronic Lymphocytic Leukemia Solid Tumors Drug: ABT-263 Drug: Ketoconazole Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)
Study Start Date : January 2010
Primary Completion Date : October 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm A (ABT-263 and Ketoconozole) Drug: ABT-263
Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
Drug: Ketoconazole
Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.

Outcome Measures

Primary Outcome Measures :
  1. To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263. [ Time Frame: Weekly ]

Secondary Outcome Measures :
  1. To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients. [ Time Frame: Daily ]

Eligibility Criteria

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

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.
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): NCT01021358

United States, Texas
Site Reference ID/Investigator# 25068
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
More Information

Responsible Party: Andrew Krivoshiik, MD, PhD, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01021358     History of Changes
Other Study ID Numbers: M10-957
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents