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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
  Purpose

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


Condition Intervention Phase
Solid Tumors
 Drug: STA 9090 (ganetespib)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

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. [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688116

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Ryer     617-632-6992     eryer@partners.org    
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Natasha Isaac     617-726-6225        
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Myles Clancy     617-632-9280        
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Dr. Patricia LoRusso     313-576-8716        
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Robert Bradley/Clinical Trial Manager, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00688116     History of Changes
Other Study ID Numbers: 9090-01
Study First Received: May 28, 2008
Last Updated: July 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
metastatic cancer
solid tumor
histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable
STA-9090
ganetespib

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013