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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00688116
• Other study ID #: 9090-01
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: September 17, 2014
• Start date: October 2007
• Est. completion date: November 2014

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes