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A Phase I Study of AZD7762 plus Irinotecan in Patients with Advanced Solid Malignancies

[Protocol 07-057]


Full Title :
A PHASE I, OPEN-LABEL, MULTI-CENTER, DOSE-ESCALATION STUDY TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AZD7762 ADMINISTERED AS A SINGLE INTRAVENOUS AGENT AND IN COMBINATION WITH WEEKLY STANDARD DOSE IRINOTECAN IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES
Purpose :

The purpose of this study is to evaluate the safety of an investigational drug called AZD7762, given at different dose levels both alone and in combination with irinotecan in patients with advanced solid tumors that have continued to grow despite standard therapy or for which no standard therapy exists.

AZD7762 appears to work by inhibiting an enzyme that cancer cells need to grow and divide. Irinotecan is an anticancer drug approved for the treatment of colon cancer. Doctors believe that AZD7762 may make irinotecan more effective against cancer cells, but they do not know how much AZD7762 should be given. The results of this study will help them determine the optimal dose of AZD7762.

Eligibility :

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

  • Patients must have an advanced solid tumor that has continued to grow despite standard therapy or for which no standard therapy exists.
  • At least 4 weeks must have passed since completion of prior radiation therapy, chemotherapy, or surgery, and patients must have recovered from any side effects. Patients may not have had prior treatment with an anthracycline drug.
  • 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. Archie Tse at 212-639-7599.

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