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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00687934
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
 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 Once-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 [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687934

Locations
United States, California
Premiere Oncology
Santa Monica, California, United States, 90404-2111
United States, Ohio
US Oncology Dayton Oncology and Hematology, P.A
Kettering, Ohio, United States, 45409
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Robert Bradley/Clinical Trial Manager, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00687934     History of Changes
Other Study ID Numbers: 9090-02, 9090-02
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 for which no
 standard therapy exists
STA-9090
ganetespib

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013