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A Phase I Study of R7112 in People with Advanced Cancers (Except Leukemia)

[Protocol 08-002]

Full Title :
A MULTI-CENTER, OPEN-LABEL, PHASE I STUDY OF SINGLE AGENT R7112 ADMINISTERED ORALLY IN PATIENTS WITH ADVANCED MALIGNANCIES, EXCEPT ALL FORMS OF LEUKEMIA
Purpose :

The purpose of this study is to find out the maximum safe dose of a new drug called R7112 that can be used in people with cancer. Researchers will evaluate the safety of different doses of R7122 in patients with cancer (except leukemia) that has returned or spread. R7112 blocks a molecule in tumor cells called HDM2, or MDM2. This causes the cell to make more of a molecule called p53. Large amounts of p53 then cause a tumor cell to self-destruct.

R7122 is taken orally (by mouth). Participants will take R7112 for 10 days in a row (or fewer), then have 18 days of rest before starting treatment again. In a phase I study, groups of patients will take a fixed dose of medication every day. Each group will take a steadily higher daily dose of R7112, until researchers see significant side effects. After that, approximately 20 people will be treated with the maximum tolerated dose of R7112 to confirm its safety.

In a phase I study, patients will have to visit the clinic multiple times in the first few weeks of the study, and will continue to have relatively frequent follow-up visits as long as they stay on the study.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of an advanced cancer that has returned or spread despite standard therapies or for which no standard therapy exists.
  • Patients with leukemia may not participate in this study.
  • At least 3 weeks must have passed since completion of any 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. Robert Maki at 212-639-5720.

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