A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors
Phase 1
25 Years
N/A
25 Years
N/A
Open (Enrolling)
Both
Solid Tumors
Both
Solid Tumors
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 Oncology | Santa Monica, California 90404 |
| US Oncology Dayton Oncology and Hematology, P.A | Kettering, Ohio 45409 |
