- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167114
STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancer
October 31, 2023 updated by: Jeffrey W. Clark, MD, Massachusetts General Hospital
A Phase 2 Clinical Trial of STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancers
In this research study, the investigators are looking to see how effective STA-9090 is in treating esophagogastric cancer.
The investigators will also evaluate the side effects of STA-9090, and examine the relationship between the presence of HSP-90 and how well study participants respond to STA-9090.
STA-9090 works by blocking a protein in tumor cells called HSP90, which is thought to play a role in tumor growth.
By interfering with this protein's function, STA-9090 may help kill tumor cells.
This drug has been used in other research studies and information from those other research studies suggests that this agent may help to slow tumor growth in esophagogastric cancer.
Study Overview
Detailed Description
- Each treatment cycle lasts 4 weeks during which time the study drug will be administered for three consecutive weeks followed by 1 week of no study drug. STA-9090 will be given by intravenous infusion.
- Participants will come to the clinic on Days 1, 8, and 15 of all cycles. At these visits, the following tests and procedures will be performed: Review of current medications and any side effects experienced; Performance status evaluation; Physical examination; Vital signs; Routine blood tests; CT scan of the chest, abdomen, and pelvis (every 2 cycles) and Optional FDG-PET scan (every 2 cycles).
- Participants may remain on this research study for as long as their cancer is responding to the study drug and they are not experiencing any severe side effects.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
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
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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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
Description
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed advanced esophageal, gastroesophageal, or gastric cancer. When possible, archived biopsy or resection specimens must be available for correlative SNaPshot and FISH studies.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan (per RECIST criteria).
- Participants must have progressed through prior 1st-line therapy. For the purposes of this trial, neoadjuvant chemoradiation or peri-operative chemotherapy may be considered as prior 1st-line treatment in the event of metastatic recurrence.
- 18 years of age or older
- Life expectancy of greater than 12 weeks
- ECOG Performance status of 1 or greater
- Participants must have normal organ and marrow function as defined in the protocol.
- Participants must have adequate peripheral IV access. Administration of STA-9090 via indwelling catheters is prohibited at this time.
- No concurrent active primary or metastatic cancer other than superficial squamous cell or basal cell skin cancer.
- At least 3 weeks or 5 half-lives must have elapsed between the most recent dose of any prior anticancer therapy and the start date of treatment with STA-9090. Participants must have resolution to baseline of all toxicities associated with prior anticancer therapies.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria:
- Participants may not be receiving any other standard or investigational anticancer agents, with the exception of hormonal therapy.
- Participants with known CNS metastases must have received whole-brain radiation or other appropriate therapy not less than 4 weeks prior to starting the study drug and exhibit clinical stability of brain disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STA-9090 or to the excipients PEG 300 and Polysorbate 80.
- Ventricular ejection fraction of 55% or less at baseline.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study. Breastfeeding should be discontinued
- HIV-positive individuals on combination antiretroviral therapy are ineligible.
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: STA-9090
All subjects receive STA-9090
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Given intravenously on Day 1, 8 and 15 of each 4 week cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy of STA-9090 in patients who have progressed through prior 1st-line treatment for esophagogastric cancer, as measured by overall response rate.
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine progression-free survival.
Time Frame: 3 years
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3 years
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To retrospectively determine the prevalence of HSP-90 clients in the tumors of subjects treated on trial.
Time Frame: 2 years
|
2 years
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To correlate the presence of HSP-clients with response rate and progression-free survival
Time Frame: 3 years
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3 years
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To determine safety, tolerability and adverse event profiles of this therapeutic regimen in the treatment of esophagogastric cancer.
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey W Clark, MD, Massachusetts General Hospital
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
August 1, 2010
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
July 21, 2010
First Posted (Estimated)
July 22, 2010
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-422
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 Esophagogastric Cancer
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Memorial Sloan Kettering Cancer CenterJanssen PharmaceuticalsRecruiting
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University Health Network, TorontoRecruiting
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Memorial Sloan Kettering Cancer CenterCompletedEsophagogastric CancerUnited States
-
Washington University School of MedicineGateway for Cancer ResearchWithdrawnEsophagogastric Cancer
-
SCRI Development Innovations, LLCGlaxoSmithKlineTerminatedHER2 Positive Esophagogastric CancerUnited States
-
Zhonglin HaoUniversity of Kentucky; BeiGeneWithdrawnEsophageal Cancer | Esophagogastric Junction CancerUnited States
-
St. James's Hospital, IrelandUnknownBarrett Esophagus | Siewert Type II Adenocarcinoma of Esophagogastric Junction | Oesophagus Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionIreland
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P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health of...Not yet recruitingEsophageal Cancer | Oesophageal Cancer | Siewert Type I Adenocarcinoma of Esophagogastric Junction | Siewert Type III Adenocarcinoma of Esophagogastric JunctionRussian Federation
-
University of Kansas Medical CenterNot yet recruitingEsophagogastric Junction Disorder
-
Memorial Sloan Kettering Cancer CenterBristol-Myers Squibb; BayerActive, not recruitingEsophagogastric Cancer | HER2-NegativeUnited States
Clinical Trials on STA-9090
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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
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Synta Pharmaceuticals Corp.CompletedNon Small Cell Lung CancerUnited States
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Memorial Sloan Kettering Cancer CenterSynta Pharmaceuticals Corp.Completed
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Synta Pharmaceuticals Corp.CompletedSolid TumorsUnited States
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David M. Jackman, MDMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...CompletedSmall Cell Lung CancerUnited States
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Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham... and other collaboratorsCompleted
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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