Esophagogastric Cancer Clinical Trial
Official title:
A Phase 2 Clinical Trial of STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancers
NCT number | NCT01167114 |
Other study ID # | 09-422 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | April 2017 |
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2017 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Synta Pharmaceuticals Corp. |
United States,
Goyal L, Chaudhary SP, Kwak EL, Abrams TA, Carpenter AN, Wolpin BM, Wadlow RC, Allen JN, Heist R, McCleary NJ, Chan JA, Goessling W, Schrag D, Ng K, Enzinger PC, Ryan DP, Clark JW. A phase 2 clinical trial of the heat shock protein 90 (HSP 90) inhibitor g — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | ||
Secondary | To determine progression-free survival. | 3 years | ||
Secondary | To retrospectively determine the prevalence of HSP-90 clients in the tumors of subjects treated on trial. | 2 years | ||
Secondary | To correlate the presence of HSP-clients with response rate and progression-free survival | 3 years | ||
Secondary | To determine safety, tolerability and adverse event profiles of this therapeutic regimen in the treatment of esophagogastric cancer. | 2 years |
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