Tuesday, December 21, 2010

Clinical Trial Information: Novitoclax (ABT-263)

Trial Information: A Phase I/Phase II study which began in 2006 seeks to enroll 98 lymphoma patients to study a new Bcl-2 inhibitor, navitoclax. Patients must have relapsed disease. The Phase I component will measure dosage in multiple types of lymphoma. The Phase II component will measure responses in follicular lymphoma and mantle cell lymphoma. Navitoclax is a daily, orally taken solution.

Background Information: An initial Phase I trial showed a 22% response rate across multiple types of lymphoma, with the majority of patients suffering side effects such as anemia, infections, diarrhea, nausea, and fatigue.

A second Phase I trial combined navitoclax with rituximab in untreated patients, resulting in a 67% response rate. In 11 follicular lymphoma patients, there were 4 complete remissions and 1 partial response.

Canadian Locations: Cross Cancer Institute (Edmonton, AB)

For more information, see ClinicalTrials.gov (#NCT00406809).

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