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A Phase I/IIa Study Evaluating ABT-263 in Patients with Relapsed or Refractory Lymphoid Malignancies
[Protocol 07-048]
- Full Title :
- A PHASE 1/2A STUDY EVALUATING THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ABT-263 IN SUBJECTS WITH RELAPSED OR REFRACTORY LYMPHOID MALIGNANCIES
- Purpose :
Laboratory studies have shown that ABT-263, an investigational new drug, kills cancer cells and causes tumors to shrink by interfering with proteins that would otherwise keep cancer cells alive. ABT-263 has not yet been evaluated in clinical trials in patients.
The purpose of the phase I portion of this study is to determine the highest dose of ABT-263 that can be given safely to patients with lymphoma or other lymphoid cancer that has either stopped responding to treatment or has returned despite prior therapy. The phase IIa portion will include a preliminary assessment of the drug's effectiveness against cancer.
Researchers will also study substances in the blood or tissue (biomarkers) that may be used to monitor the drug's activity and the progress of the disease. ABT-263 is a liquid that is taken by mouth.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- For the phase I portion, of the study, patients must have a confirmed diagnosis of lymphoma or other lymphoid cancer that has progressed or returned despite treatment with at least one regimen of chemotherapy. Patients with Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma may not participate.
- For the phase IIa portion of the study, patients must have a confirmed diagnosis of follicular lymphoma that has progressed or returned despite at least one but no more than four prior regimens of chemotherapy.
- At least 2 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients may not have had a prior stem cell transplant.
- Patients in the phase I portion must not be confined to a bed or chair for more than half of their normal waking hours. Patients in the phase II portion must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.
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