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

Completed · Phase 1/Phase 2

Conditions studied: Malignant Peripheral Nerve Sheath Tumors (MPNST), Sarcoma

In brief

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.

Key facts

Study ID

NCT02008877

Run by

Sarcoma Alliance for Research through Collaboration

People needed

20

Starts

2013-12-01

Expected to finish

2018-07-01

Last updated by the study team

2019-05-15

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Iowa — Iowa City, Iowa, United States
• National Cancer Institute — Bethesda, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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