SARC023: Ganetespib and Sirolimus in Patients With MPNST (Malignant Peripheral Nerve Sheath Tumors)

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended dose of ganetespib when administered in combination with sirolimus in patients with refractory or relapsed sarcomas including unresectable or metastatic sporadic or neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed.

Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for patients with unresectable or metastatic sporadic or NF1 associated MPNST.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarcoma Alliance for Research through Collaboration
• Collaborators: Synta Pharmaceuticals Corp.; United States Department of Defense
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Patients ≥ 16 years old

• Patients with unresectable or metastatic histologically confirmed sporadic or NF1 associated high grade MPNST

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• Patients must have at least 1 measurable tumor

• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy (toxicity < grade 2)

• Must be able to swallow whole pills

• Adequate organ function

• Normal fasting cholesterol and triglycerides

• May be on cholesterol medications

Exclusion Criteria:

• Patients receiving current treatment with corticosteroids or another immunosuppressive. Topical or inhaled corticosteroids are allowed.

• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases

• Symptomatic congestive heart failure

• Severely impaired lung function

• Significant vascular disease

• Uncontrolled diabetes

• Active (acute or chronic) or uncontrolled severe infections hepatitis

• Impairment of gastrointestinal function

• Patients with an active, bleeding diathesis or significant coagulopathy

• Use of cytochrome P450 isoenzyme 3A4 (CYP3A4)/ CYP2C19 substrates