Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Synta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: STA-9090

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687934

9090-02

Details and patient eligibility

About

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Enrollment: 53 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

Ganetespib

Experimental group

Description:

Ganetespib once weekly infusion, dose escalation study, with treatment until progression

Treatment:

Drug: STA-9090