- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858572
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
September 17, 2014 updated by: Synta Pharmaceuticals Corp.
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
-
-
New York
-
New York, New York, United States, 10065
-
-
Texas
-
San Antonio, Texas, United States, 78229
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Males and females 18 years or older
- Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
- Must have acceptable organ function during screening as defined in the protocol
Exclusion Criteria
- Pregnant or breast-feeding women
- Patients must meet the washout periods for prior chemotherapies and radiation
- History of stroke within 6 months of treatment
- Poor venous access for study drug administration
- Treatment with chronic immunosuppressants
- Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort
|
Chemotherapy agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
Time Frame: Feb 2011
|
Feb 2011
|
To assess preliminary evidence of anti-neoplastic activity
Time Frame: Feb 2011
|
Feb 2011
|
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Time Frame: Feb 2011
|
Feb 2011
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess changes in biomarkers following study drug administration
Time Frame: Feb 2011
|
Feb 2011
|
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
Time Frame: Feb 2011
|
Feb 2011
|
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Time Frame: Feb 2011
|
Feb 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2009
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
March 6, 2009
First Submitted That Met QC Criteria
March 9, 2009
First Posted (Estimate)
March 10, 2009
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9090-03
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 Myeloproliferative Disorders
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedLeukemia | Chronic Myeloproliferative Disorders | Myelodysplastic/Myeloproliferative DiseasesUnited States
-
Sociedad de Lucha Contra el Cáncer del EcuadorCompletedMyeloproliferative Disorders | Myeloproliferative Neoplasm | Myeloproliferative Syndrome | Myeloproliferative Neoplasm, Unclassifiable | Myeloproliferative Disease, Not ClassifiedEcuador
-
The First Affiliated Hospital of Soochow UniversityEnrolling by invitationMyelodysplastic/Myeloproliferative Neoplasms | AdultChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or AnemiaAnemia | Myelofibrosis | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedMyelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified | Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise SpecifiedUnited States
-
University of California, IrvineCompletedMyeloproliferative NeoplasmUnited States
-
Fondazione per la Ricerca Ospedale MaggioreCompletedMyeloproliferative NeoplasmItaly, United Kingdom, Germany, France, United States, Spain, Canada
-
Safaa AA KhaledUnknownMyeloproliferative Neoplasm
-
M.D. Anderson Cancer CenterCTI BioPharmaTerminatedMyeloproliferative DiseasesUnited States
-
Assiut UniversityUnknownMyeloproliferative Neoplasm
Clinical Trials on STA-9090 (ganetespib)
-
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
-
David M. Jackman, MDMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...CompletedSmall Cell Lung CancerUnited States
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham... and other collaboratorsCompleted
-
Synta Pharmaceuticals Corp.CompletedAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | AML | CML | ALL | Blast-phase Chronic Myelogenous LeukemiaUnited States
-
Synta Pharmaceuticals Corp.UnknownSolid TumorsUnited States
-
Dana-Farber Cancer InstituteSynta Pharmaceuticals Corp.TerminatedMelanomaUnited States
-
Synta Pharmaceuticals Corp.CompletedGastrointestinal Stromal TumorUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.CompletedRectal CancerUnited States
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube CancerUnited States
-
Synta Pharmaceuticals Corp.TerminatedNon-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage IIIB | Non-small Cell Lung Cancer Stage IV | Non-Small-Cell Lung AdenocarcinomaUnited States, France, Spain, Netherlands, Czech Republic, Serbia, Romania, Germany, Belgium, Italy, Hungary, United Kingdom, Canada, Poland, Bosnia and Herzegovina, Austria, Slovenia, Croatia, Russian Federation, Ukraine