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

Abbott

Status and phase

Completed

Phase 1

Conditions

Lymphoma

Chronic Lymphocytic Leukemia

Solid Tumors

Treatments

Drug: ABT-263

Drug: Ketoconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01021358

M10-957

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.