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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Chronic Lymphocytic Leukemia, Solid Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

M10-957

NCT ID:

NCT01021358

Start Date:

January 2010

Completion Date:

Related Keywords:

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

Name

Location

Site Reference ID/Investigator# 25068San Antonio, Texas  78229