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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00688116
First received: May 28, 2008
Last updated: September 17, 2014
Last verified: September 2014

May 28, 2008
September 17, 2014
October 2007
April 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00688116 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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.
Experimental: ganetespib
Intervention: Drug: STA 9090 (ganetespib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
November 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00688116
9090-01
No
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP