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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183364
First Posted: August 17, 2010
Last Update Posted: September 19, 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
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 Intervention Phase
Solid Tumor Malignancies Drug: STA-9090 (ganetespib) with Docetaxel Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • 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:
  • 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).


Enrollment: 27
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT01183364


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

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01183364     History of Changes
Other Study ID Numbers: 9090-07
First Submitted: August 11, 2010
First Posted: August 17, 2010
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Synta Pharmaceuticals Corp.:
solid tumor malignancies
tumor
cancer
STA-9090
ganetespib
HSP90 inhibitor

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