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

NCT01021358 | Completed Phase 1

• 1 other identifier: M10-957
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Chronic Lymphocytic Leukemia; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.

  Weekly

Secondary Outcomes (1)

• To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.

  Daily

Study Arms (1)

Arm A (ABT-263 and Ketoconozole)

EXPERIMENTAL

Drug: ABT-263; Drug: Ketoconazole

Interventions

ABT-263 DRUG

Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.

Arm A (ABT-263 and Ketoconozole)

Ketoconazole DRUG

Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.

Arm A (ABT-263 and Ketoconozole)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 25068

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

navitoclax; Ketoconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Last Updated: December 20, 2010

Record last verified: 2010-12

Locations

US (1)