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A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)


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

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Trial Information

A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)

Inclusion 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.

Exclusion Criteria

- 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.

- 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).

- Subject exhibits evidence of other clinically significant uncontrolled condition(s)
including, but not limited to:

- tuberculosis

- diagnosis of fever and neutropenia within 1 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 Subject is currently receiving or
requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal
supplements that affect platelet function, with the exception of low-dose heparin
used to maintain the patency of a catheter.

- Subject has used known inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin
and carbamazepine) of cytochrome P450 3A (CYP3A) within 1 week prior to first dose of
study.

- Subject has a history of hypersensitivity to any of the rifamycins.

- 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 rifampin on the pharmacokinetics of navitoclax.

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

M10-955

NCT ID:

NCT01121133

Start Date:

May 2010

Completion Date:

May 2011

Related Keywords:

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

Name

Location

Site Reference ID/Investigator# 35742Santa Monica, California  90404