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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01183364
First received: August 11, 2010
Last updated: September 18, 2014
Last verified: September 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    The number of adverse events will be used as a measure of safety


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183364

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

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01183364     History of Changes
Other Study ID Numbers: 9090-07
Study First Received: August 11, 2010
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014