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).

Navitoclax: A New Protein Inhibitor for Lymphoma

Also known as: ABT-263


Drug Information: Protein and enzyme inhibitors are novel new therapies for follicular lymphoma which remain experimental, but are highly promising. One such drug is navitoclax.

Trial Information: A Phase II trial of navitoclax is ongoing as of 2010, and includes sites in Canada.

In an American Phase I trial initiated in 2006, most of the 55 patients enrolled suffered from side effects like anemia, infection, low blood cell counts, diarrhea, nausea, and fatigue. The patients had varying types of lymphomas, and there was a 22% overall response rate (median progression-free survival, 15 months). Another Phase I trial combined navitoclax with rituximab as first-line treatment, resulting in a 67% overall response rate, including 4 complete remissions and 1 partial response in 11 follicular lymphoma subjects (45%).

Published Studies

Brad Kahl et al. "Navitoclax (ABT-263) Plus Rituximab." ASH Convention, 2010.

Wyndham H. Wilson et al. "Navitoclax, A Targeted High-Affinity of BCL-2." Lancet Oncology (2010).

Research Highlights: Week of December 20, 2010

Beyond my own ramblings, here is an overview of some of the published work that may be of interest to people living with lymphoma, over the past week. I'm skipping over the recent material from ASH, which is of interest in itself. More on that later, perhaps, but there were plenty of interesting papers there, too. Here I look at the December 16 issue of Blood, the December 20 issue of the Journal of Clinical Oncology, December 2010 issues of the British Journal of Cancer, CA, Clinical Lymphoma, Myeloma & Leukemia, Lancet Oncology, and Leukemia & Lymphoma (as dense as always).