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A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors


Phase 1
25 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors


Inclusion Criteria:



- Patients must be documented to be refractory or not candidates for current approved
therapies.

- Must have an ECOG status 0-2.

- Peripheral neuropathy < or = 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.

- Chemotherapy or radiation within 3 weeks.

- Previous radiation to >25% of total bone marrow.

- Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell
transplantation.

- Primary brain tumors or active brain metastases.

- Use of any investigational agents within 4 weeks.

- Treatment with chronic immunosuppressants.

- Uncontrolled, intercurrent illness.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities

Outcome Time Frame:

Cycle 1

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

9090-02

NCT ID:

NCT00687934

Start Date:

October 2007

Completion Date:

September 2011

Related Keywords:

  • Solid Tumors
  • metastatic cancer
  • solid tumor
  • histologically or cytologically confirmed non-hematological
  • malignancy that is metastatic or unresectable for which no
  • standard therapy exists
  • STA-9090
  • ganetespib
  • Neoplasms

Name

Location

Premiere OncologySanta Monica, California  90404
US Oncology Dayton Oncology and Hematology, P.AKettering, Ohio  45409