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

Phase 1CompletedNCT00687934

Synta Pharmaceuticals Corp.53 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

STA-9090DRUG

This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Locations (2)

Premiere Oncology

Santa Monica, California, United States

US Oncology Dayton Oncology and Hematology, P.A

Kettering, Ohio, United States

Outcomes

Primary Outcomes

The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities

Time frame: Cycle 1

Data from ClinicalTrials.gov

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