Overview

This trial is active, not recruiting.

Condition solid tumors
Treatment sta 9090 (ganetespib)
Phase phase 1
Sponsor Synta Pharmaceuticals Corp.
Start date October 2007
End date April 2014
Trial size 45 participants
Trial identifier NCT00688116, 9090-01

Summary

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sta 9090 (ganetespib)
This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.

Primary Outcomes

Measure
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
time frame: Cycle 1

Eligibility Criteria

Male or female participants at least 25 years old.

Inclusion Criteria: - Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2. - Must have acceptable organ and marrow function per protocol parameters. - No clinically significant ventricular arrythmias or ischemia. Exclusion Criteria: - Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks.. - No previous radiation to >25% of total bone marrow. - No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation. - No primary brain tumors or active brain metastases. - No use of any investigational agents within 4 weeks. - No treatment with chronic immunosuppressants. - No uncontrolled, intercurrent illness.

Additional Information

Official title A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Description This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Synta Pharmaceuticals Corp..