Esophagogastric CancerPhase 2NCT01167114
STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancer
A Phase 2 study testing STA-9090 in people with Esophagogastric Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Cancer
- What is being tested?
- STA-9090
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophagogastric Cancer
- Being tested
- STA-9090
- Keywords
- STA-9090
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-9090Drug
Given intravenously on Day 1, 8 and 15 of each 4 week cycle.
| Study group | Role | What they receive |
|---|---|---|
| STA-9090 | Experimental | All subjects receive STA-9090 Receives: Drug: STA-9090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
To determine progression-free survival.
Measured: 3 years
To retrospectively determine the prevalence of HSP-90 clients in the tumors of subjects treated on trial.
Measured: 2 years
To correlate the presence of HSP-clients with response rate and progression-free survival
Measured: 3 years
To determine safety, tolerability and adverse event profiles of this therapeutic regimen in the treatment of esophagogastric cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagogastric CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Synta Pharmaceuticals Corp.
- Responsible party
- Principal investigator, Jeffrey W. Clark, MD, Massachusetts General Hospital
- Investigators
- Jeffrey W Clark, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167114
- Sponsor's protocol ID
- 09-422
- Status last verified
- Oct 2023
- First submitted
- 13 Jan 2010
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 ganetespib in patients with refractory advanced esophagogastric cancer. Invest New Drugs. 2020 Oct;38(5):1533-1539. doi: 10.1007/s10637-019-00889-y. Epub 2020 Jan 2.
PubMed 31898183
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial of STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancers
- ClinicalTrials.gov ID
- NCT01167114
- Acronym / sponsor ID
- 09-422
- Conditions
- Esophagogastric Cancer
- Keywords
- STA-9090
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Synta Pharmaceuticals Corp.
- Study start
- Aug 2010
- Primary completion
- May 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STA-9090 | Experimental | Drug: STA-9090All subjects receive STA-9090 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA-9090Given intravenously on Day 1, 8 and 15 of each 4 week cycle. | Drug | STA-9090 |
Primary outcome
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
4 secondary outcomes
To determine progression-free survival.
Time frame: 3 years
To retrospectively determine the prevalence of HSP-90 clients in the tumors of subjects treated on trial.
Time frame: 2 years
To correlate the presence of HSP-clients with response rate and progression-free survival
Time frame: 3 years
To determine safety, tolerability and adverse event profiles of this therapeutic regimen in the treatment of esophagogastric cancer.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Results publication: PubMed 31898183Goyal 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 ganetespib in patients with refractory advanced esophagogastric cancer. Invest New Drugs. 2020 Oct;38(5):1533-1539. doi: 10.1007/s10637-019-00889-y. Epub 2020 Jan 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey W Clark, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STA-9090 in people with Esophagogastric Cancer, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01167114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.