Clinical trial NCT01021358: A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
Official title: A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Chronic Lymphocytic Leukemia
Solid Tumors
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263.
timeFrame: Weekly
Secondary outcomes:
measure: To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients.
timeFrame: Daily
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 25068
state: Texas
Study officials:
References: