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A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors

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. Identifier: NCT01183364
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Brief Summary:
This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.

Condition or disease Intervention/treatment Phase
Solid Tumor Malignancies Drug: STA-9090 (ganetespib) with Docetaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: STA-9090 and Docetaxel
STA-9090 (ganetespib) and Docetaxel
Drug: STA-9090 (ganetespib) with Docetaxel
One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.

Primary Outcome Measures :
  1. Safety of STA-9090 (ganetespib) and docetaxel combination [ Time Frame: June 2011 ]
    The number of adverse events will be used as a measure of safety

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: June 2011 ]
    Pharmacokinetics of STA-9090 (ganetespib) and Docetaxel. This includes concentrations of these drugs in patients' blood at various protocol-specified times relative to the time of dose administration. These will be summarized by parameters including maximum concentration, total exposure and how fast the patient's body gets rid of the drug (known as Cmax, AUC, t1/2, respectively).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression
  • If subject has been treated with docetaxel, must have evidence of persistent or progressive disease
  • Measurable disease per RECIST
  • CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose
  • ECOG status less than or equal to 2
  • Life expectancy greater than 3 months
  • Adequate hematological, hepatic and renal function as defined by protocol
  • Willingness and ability to comply with study requirements
  • Female subjects of childbearing age must have a negative pregnancy test at study entry
  • Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol

Exclusion Criteria:

  • Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose
  • Radiotherapy within 2 weeks of first dose
  • Surgery, radiotherapy or ablative procedure to the only area of measurable disease
  • Major surgery within 4 weeks of first dose
  • Poor venous access that would require an indwelling catheter for study drug administration
  • History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients
  • Baseline QTc >470 msec or previous history of QT prolongation while taking other medications
  • Peripheral neuropathy > Grade 1
  • Ventricular ejection fraction less than or equal to 55% at baseline
  • Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases
  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness

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 identifier (NCT number): NCT01183364

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United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Synta Pharmaceuticals Corp.

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Responsible Party: Synta Pharmaceuticals Corp. Identifier: NCT01183364     History of Changes
Other Study ID Numbers: 9090-07
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Synta Pharmaceuticals Corp.:
solid tumor malignancies
HSP90 inhibitor

Additional relevant MeSH terms:
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Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action