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A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor Malignancies

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Trial Information

A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of STA-9090 (ganetespib) and docetaxel combination

Outcome Description:

The number of adverse events will be used as a measure of safety

Outcome Time Frame:

June 2011

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

9090-07

NCT ID:

NCT01183364

Start Date:

July 2010

Completion Date:

October 2012

Related Keywords:

  • Solid Tumor Malignancies
  • solid tumor malignancies
  • tumor
  • cancer
  • STA-9090
  • ganetespib
  • HSP90 inhibitor
  • Neoplasms

Name

Location

Emory University School of MedicineAtlanta, Georgia  30322