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

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ClinicalTrials.gov Identifier: NCT00688116
Recruitment Status : Unknown
Verified September 2014 by Synta Pharmaceuticals Corp..
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: STA 9090 (ganetespib) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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 Twice-Weekly in Patients With Solid Tumors
Study Start Date : October 2007
Primary Completion Date : April 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ganetespib 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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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 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

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): NCT00688116


Locations
United States, California
UCLA
Los Angeles, California, United States
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00688116     History of Changes
Other Study ID Numbers: 9090-01
First Posted: June 2, 2008    Key Record Dates
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
STA-9090
ganetespib