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CLINICAL TRIALS

Clinical trials are a fundamental step in the development of new therapies for treating virtually every medical condition. At Synta Pharmaceuticals, our clinical research is focused on innovative therapeutic options that can extend or enhance the lives of patients in the areas of cancer and inflammatory diseases. All of the drug candidates currently in development at Synta are derived from our proprietary chemical compound library and reflect our commitment to truly original research.

Synta places a high priority on sharing information and results regarding our ongoing and completed clinical studies with the medical community. We have registered all of our active, company-sponsored clinical trials on the National Institutes of Health Web site www.clinicaltrials.gov. This information is available here on our site, as well.

No Synta drug candidates have been approved by the FDA or any other regulatory body for the treatment of diseases.

Ganetespib

Ganetespib is a potent, second-generation, small molecule Hsp90 inhibitor (inhibits heat shock protein 90 - Hsp90 a chaperone that regulates numerous proteins that drive proliferation in cancer cells, in particular kinases) that has shown strong activity in a broad range of preclinical solid and hematologic cancer models, including models highly resistant to treatment. The chemical structure of ganetespib is unrelated to the first generation, ansamycin family of Hsp90 inhibitors (e.g., 17-AAG or IPI-504).

GALAXY Trial TM (Ganetespib Assessment in Lung cAncer with docetaXel)
Phase 2b/3 Trial in Non-Small Cell Lung Cancer in Combination with Docetaxel

This is a randomized, Phase 2b/3 study of ganetespib (STA-9090) in combination with docetaxel versus docetaxel alone being conducted in patients with stage IIIb or IV non-small cell lung cancer (NSCLC). The primary objectives are to measure change in progression free survival and overall survival. Click here for more information on this trial.

Phase 1 in Combination with Docetaxel in Solid Tumors

Results from this trial were announced in September 2011 and at The European Multidisciplinary Cancer Congress.

Phase 2 Trial in Non-Small Cell Lung Cancer

Results from this trial were announced in June 2011 and at ASCO 2011.

Phase 2 Trial in Colorectal Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with advanced colon cancer or rectal cancer. Click here for more information on this trial.

Phase 2 Trial in Gastric Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with advanced gastric, esophageal, or gastroesophageal cancers. Click here for more information on this trial.

Phase 2 Trial in Ocular Melanoma

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with metastatic ocular melanoma. Click here for more information on this trial.

Phase 2 Trial in Pancreatic Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with metastatic pancreatic cancer. Click here for more information on this trial.

Phase 2 Trial in Prostate Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy. Click here for more information on this trial.

Phase 2 in Combination with Dutasteride in Prostate Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with castration-resistant prostate cancer (CRPC). Click here for more information on this trial.

Phase 2 Trial in Breast Cancer

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with metastatic breast cancer. Click here for more information on this trial.

Phase 2 Trial in Melanoma

This is an open-label, investigator-sponsored Phase 2 clinical study being conducted in patients with unresectable stage III or stage IV melanoma who were intolerant of or progressed on prior tyrosine kinase inhibitor (TKI) treatment.

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Elesclomol

Phase 2 in Combination with Paclitaxel in Ovarian Cancer

This is a Phase 2 single-arm, open-label study in patients with recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have progressed on platinum-based therapy. Click here for more information on this trial.

Phase 1 Trial in Acute Myeloid Leukemia (AML)

This is a Phase 1 dose-escalation study of elesclomol sodium in patients with relapsed or refractory acute myeloid leukemia (AML). The primary objectives of study are to characterize safety, tolerability, and pharmacokinetics. Additional objectives are to identify the phase 2 dose and characterize signs of biologic and clinical activity. Click here for more information on this trial.

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