At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 20 enrolled

Drug / intervention

ganetespib +1 moredrug

Likely dose

ganetespib 150 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02008877

NCT02008877Phase 2Completed

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A Phase I/II Trial of Ganetespib in Combination With the mTOR Inhibitor Sirolimus for Patients With Recurrent or Refractory Sarcomas Including Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors

Sarcoma Alliance for Research through Collaboration·interventional·Posted Dec 11, 2013·Updated May 15, 2019

In Brief

A Phase 2 clinical trial evaluating ganetespib and Sirolimus for Malignant Peripheral Nerve Sheath Tumors (MPNST) and Sarcoma. Completed, enrolled 20 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalignant Peripheral Nerve Sheath Tumors (MPNST), Sarcoma

CountriesUnited States

CollaboratorsSynta Pharmaceuticals Corp., United States Department of Defense

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartDec 2013

First PostedDec 2013

Primary CompletionApr 2018

Study CompletionJul 2018

TodayJul 2026

First PostedDec 11, 2013

Enrollment StartDec 1, 2013

Primary CompletionApr 1, 2018

Study CompletionJul 1, 2018

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 12.6 years ago

Interventions

ganetespibdrug

Phase 1 Dose 1: 150 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour; Phase 1 Dose 2: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour; Phase 2: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour

Sirolimusdrug

4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only.