Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT00687934

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

26.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: STA-9090	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ganetespib Ganetespib once weekly infusion, dose escalation study, with treatment until progression	Drug: STA-9090 This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Arm

Intervention/Treatment

Experimental: Ganetespib

Ganetespib once weekly infusion, dose escalation study, with treatment until progression

Drug: STA-9090

This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Outcome Measures

Primary Outcome Measures

The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities [Cycle 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must be documented to be refractory or not candidates for current approved therapies.
Must have an ECOG status 0-2.
Peripheral neuropathy < or = 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.
Chemotherapy or radiation within 3 weeks.
Previous radiation to >25% of total bone marrow.
Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
Primary brain tumors or active brain metastases.
Use of any investigational agents within 4 weeks.
Treatment with chronic immunosuppressants.
Uncontrolled, intercurrent illness.