A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

Synta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: STA 9090

Study type: Interventional

Funder types: Industry

Identifiers

NCT01031225

9090-06

Details and patient eligibility

About

This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
• Availability of tissue for analysis
• ECOG Performance Status 0 or 1
• Adequate organ function as defined in the protocol.
• Must be at least 18 years old and able and willing to sign a written informed consent document

Exclusion criteria

• Poor venous access requiring an indwelling catheter for study drug administration
• Women who are pregnant or lactating
• Ventricular ejection fraction < or = to 55% at baseline
• Any uncontrolled intercurrent illness

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 1 patient group

1

Experimental group

Treatment:

Drug: STA 9090