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

This study is currently recruiting participants.

Verified July 2011 by Synta Pharmaceuticals Corp.

Sponsor:

Information provided by:

Synta Pharmaceuticals Corp.

ClinicalTrials.gov Identifier:

NCT00688116

First received: May 28, 2008

Last updated: July 8, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 28, 2008
Last Updated Date	July 8, 2011
Start Date ^ICMJE	October 2007
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 8, 2011)	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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: May 30, 2008)	The safety and tolerability of STA-9090 in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug. [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00688116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Official Title ^ICMJE	A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Brief Summary	An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Solid Tumors
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	45
Estimated Completion Date	December 2011
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	25 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00688116
Other Study ID Numbers ^ICMJE	9090-01
Has Data Monitoring Committee	No
Responsible Party	Robert Bradley/Clinical Trial Manager, Synta Pharmaceuticals Corp.
Study Sponsor ^ICMJE	Synta Pharmaceuticals Corp.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Synta Pharmaceuticals Corp.
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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