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


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

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Trial Information

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


This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated
with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.


Inclusion Criteria:



- Patients must be documented to be refractory or not candidates for current approved
therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?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. -No chemotherapy or radiation within 3 weeks..

- No previous radiation to >25% of total bone marrow.

- No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem
cell transplantation.

- No primary brain tumors or active brain metastases.

- No use of any investigational agents within 4 weeks.

- No treatment with chronic immunosuppressants.

- No 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 and evaluation of Adverse Events in relation to Study Drug.

Outcome Time Frame:

Cycle 1

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

9090-01

NCT ID:

NCT00688116

Start Date:

October 2007

Completion Date:

December 2011

Related Keywords:

  • Solid Tumors
  • metastatic cancer
  • solid tumor
  • histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable
  • STA-9090
  • ganetespib
  • Neoplasms

Name

Location
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana Farber Cancer Institute Boston, Massachusetts  02115
Wayne State University/Karmanos Cancer Institute Detroit, Michigan  48201
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center Boston, Massachusetts  02115