Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
1 other identifier
interventional
45
1 country
5
Brief Summary
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2007
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 28, 2008
CompletedFirst Posted
Study publicly available on registry
June 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedSeptember 18, 2014
September 1, 2014
6.5 years
May 28, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
Cycle 1
Study Arms (1)
ganetespib
EXPERIMENTALInterventions
This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., \[Monday, Thursday\] or \[Tuesday, Friday\]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.
Eligibility Criteria
You may qualify if:
- Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2.
- Must have acceptable organ and marrow function per protocol parameters.
- No clinically significant ventricular arrythmias or ischemia.
You may not qualify if:
- Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks..
- No previous radiation to \>25% of total bone marrow.
- No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
- No primary brain tumors or active brain metastases.
- No use of any investigational agents within 4 weeks.
- No treatment with chronic immunosuppressants.
- No uncontrolled, intercurrent illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
UCLA
Los Angeles, California, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2008
First Posted
June 2, 2008
Study Start
October 1, 2007
Primary Completion
April 1, 2014
Study Completion
November 1, 2014
Last Updated
September 18, 2014
Record last verified: 2014-09