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

Lymphoma Clinical Trial

Official title:

A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021358
• Other study ID #: M10-957
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2009
• Last updated: December 16, 2010
• Start date: January 2010

Study information

• Verified date: December 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 25068	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.		Weekly	Yes
Secondary	To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.		Daily	Yes