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

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00688116

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

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 (ganetespib)	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 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 Twice-Weekly in Patients With Solid Tumors

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ganetespib	Drug: 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.

Arm

Intervention/Treatment

Experimental: ganetespib

Drug: 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.

Outcome Measures

Primary Outcome Measures

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. [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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States
2	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
3	Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center	Boston	Massachusetts	United States	02115
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201