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

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

Completed

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Key information

Conditions

Solid Tumors Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Premiere Oncology, Santa Monica, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STA-9090

Drug

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.

Primary outcomes

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

Time frame: Cycle 1

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study title

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Jun 2, 2008
Registry last updated: Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed