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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687934
First Posted: June 2, 2008
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
  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
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 Once-Weekly in Patients With Solid Tumors

Resource links provided by NLM:


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 ]

Enrollment: 53
Study Start Date: October 2007
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ganetespib
Ganetespib once weekly infusion, dose escalation study, with treatment until progression
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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00687934     History of Changes
Other Study ID Numbers: 9090-02
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: September 18, 2014
Last Verified: September 2014

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