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A Phase IB Study Evaluating the Safety of BSI-201 in Combination with Chemotherapeutic Regimens in Patients with Advanced Solid Tumors
[Protocol 08-048]
- Full Title :
- A PHASE IB, OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY OF BSI-201 IN COMBINATION WITH CHEMOTHERAPEUTIC REGIMENS IN SUBJECTS WITH ADVANCED SOLID TUMORS
- Purpose :
BSI-201 is an investigational drug designed to interfere with tumor growth by inhibiting an enzyme called PARP; this inhibition may make a tumor more sensitive to the cancer-killing effects of other chemotherapy drugs. In laboratory studies, BSI-201 was shown to reduce the rate of tumor growth, and shrank tumors in some cases. When BSI-201 was tested in combination with the anticancer drugs topotecan and temozolomide, no additional side effects were observed in mice, and sometimes additional benefit was seen.
In this study, researchers want to determine the highest dose of BSI-201 that can be given safely with each of two other chemotherapy drugs in patients: topotecan in patients with advanced ovarian cancer, and temozolomide in patients with advanced sarcoma. In both cases, the patients must have a cancer that can no longer be treated with standard therapies.
The effect of the overall treatment on patients' tumors will also be studied. Imaging scans will be done to assess the size of patients' tumors, and blood tests will be performed to measure PARP activity.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients in the topotecan arm of the study must have advanced ovarian cancer that persists despite or cannot be treated with standard therapies, and patients in the temozolomide arm must have advanced sarcoma that cannot be treated with other therapies.
- For sarcoma patients in the temozolomide part of the atudy, patients may not have had more than two prior regimens of chemotherapy for metastatic disease. There is no limit to the number of prior therapies for ovarian cancer patients, but they may not have previously received topotecan.
- At least 2 weeks must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects,
- Patients 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. Katherine M. Bell-McGuinn at 212-639-8396.
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