- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00687934
Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors
September 17, 2014 updated by: Synta Pharmaceuticals Corp.
A Phase 1 Study of the HSP90 Inhibitor, 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)
Study Overview
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Monica, California, United States, 90404-2111
- Premiere Oncology
-
-
Ohio
-
Kettering, Ohio, United States, 45409
- US Oncology Dayton Oncology and Hematology, P.A
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ganetespib
Ganetespib once weekly infusion, dose escalation study, with treatment until progression
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities
Time Frame: Cycle 1
|
Cycle 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 28, 2008
First Submitted That Met QC Criteria
May 30, 2008
First Posted (Estimate)
June 2, 2008
Study Record Updates
Last Update Posted (Estimate)
September 18, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9090-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumors
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
Alphamab (Australia) Co Pty Ltd.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsAustralia
Clinical Trials on STA-9090
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
Synta Pharmaceuticals Corp.CompletedNon Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterSynta Pharmaceuticals Corp.Completed
-
David M. Jackman, MDMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...CompletedSmall Cell Lung CancerUnited States
-
Massachusetts General HospitalDana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...CompletedEsophagogastric CancerUnited States
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham... and other collaboratorsCompleted
-
Massachusetts General HospitalDana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...Completed
-
Synta Pharmaceuticals Corp.CompletedAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | AML | CML | ALL | Blast-phase Chronic Myelogenous LeukemiaUnited States
-
Synta Pharmaceuticals Corp.UnknownSolid TumorsUnited States
-
Synta Pharmaceuticals Corp.CompletedMyeloproliferative Disorders | AML | MDS | CMLUnited States