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 |
