Breast CancerPhase 2EnchantNCT01677455
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
A Phase 2 study testing ganetespib in people with Breast Cancer and HER-2 Positive Breast Cancer, run by Synta Pharmaceuticals Corp. at 25 sites in 8 countries.
Trial summary
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, HER-2 Positive Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- ganetespib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 25 sitesin 8 countries
- Study dates
- Jul 2012to Aug 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of invasive breast cancer.
- Stage IV disease.
- Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment.
- ECOG Performance status 0-1.
- Measurable disease per RECIST (1.1).
- Adequate hematological function per protocol.
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- Adequate hepatic function per protocol.
- Adequate renal function per protocol.
- Negative serum pregnancy test at study entry for patients of childbearing potential.
- Ability to understand and sign written consent and to comply with the study protocol.
Who cannot join
- Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening.
- Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.
- Bone as the only site of metastatic disease from breast cancer.
- Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib.
- Pregnancy or lactation.
- Known serious cardiac illness.
- Uncontrolled intercurrent illness per protocol.
- Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
United States8 sites
Synta Pharmaceuticals Investigative Site
Altanta, Georgia, 30341
Synta Pharmaceuticals Investigative Site
Birmingham, Alabama, 35249
Synta Pharmaceuticals Investigative Site
Boston, Massachusetts, 02111
Synta Pharmaceuticals Investigative Site
Columbus, Ohio, 43210
Synta Pharmaceuticals Investigative Site
Durham, North Carolina, 27710
Synta Pharmaceutical Investigative Site
Houston, Texas, 77030
Synta Pharmaceuticals Investigative Site
New York, New York, 10065
Synta Pharmaceuticals Investigative Site
Philadelphia, Pennsylvania, 19111-2497
United Kingdom5 sites
Synta Pharmaceutical Investigative Site
Edinburgh, EH4 2XU
Synta Pharmaceutical Investigative Site
Glasgow, G12 0YN
Synta Pharmaceutical Investigative Site
Nottingham, NG51PB
Synta Pharmaceuticals Investigative Site
Oxford, OX3 9DU
Synta Pharmaceutical Investigative Site
Peterborough, PE3 9GZ
South Korea4 sites
Synta Pharmaceutical Investigative Site
Seoul, Gangnam-GU
Synta Pharmaceuticals Investigative Site
Seoul, Jongno-Gu
Synta Pharmacuetical Investigative Site
Seoul, Seodaemun-GU
Synta Pharmaceuticals Investigative Site
Seoul, Songpa-Gu
Belgium3 sites
Synta Pharmaceuticals Investigative Site
Brussels, B-1000
Synta Pharmaceutical Investigative Site
Charleroi, 6000
Synta Pharmaceuticals Investigative Site
Wilrijk, 2610
Argentina2 sites
Synta Pharmaceuticals Investigative Site
Córdoba
Synta Pharmaceuticals Investigative Site
Rosario Santa Fe, S2000KZE
About this study
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.
- Conditions
- Breast Cancer, HER-2 Positive Breast Cancer, Triple Negative Breast Cancer, ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment
- Being tested
- ganetespib
- Keywords
- Hsp90 inhibitor, ganetespib, STA 9090
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganetespibDrug
Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
| Study group | Role | What they receive |
|---|---|---|
| HER2+ breast cancer | Experimental | Not described Receives: Drug: ganetespib |
| Triple negative breast cancer | Experimental | Closed to enrollment Receives: Drug: ganetespib |
| ER/PR+ Refractory to Prior Hormonal Treatment | Experimental | Not described Receives: Drug: ganetespib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate is based on RECIST criteria
Measured: Week 12
Secondary outcomes (1)
Duration of response and progression free survival
Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study.
Measured: Every six weeks until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677455
- Sponsor's protocol ID
- 9090-11
- Acronym
- Enchant
- Status last verified
- Nov 2015
- First submitted
- 9 Jul 2012
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01677455
- Acronym / sponsor ID
- Enchant / 9090-11
- Conditions
- Breast Cancer, HER-2 Positive Breast Cancer, Triple Negative Breast Cancer, ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment
- Keywords
- Hsp90 inhibitor, ganetespib, STA 9090
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Sep 2012 (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.
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HER2+ breast cancer | Experimental | Drug: ganetespib |
| Triple negative breast cancer | Experimental | Drug: ganetespibClosed to enrollment |
| ER/PR+ Refractory to Prior Hormonal Treatment | Experimental | Drug: ganetespib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed diagnosis of invasive breast cancer.
- Stage IV disease.
- Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment.
- ECOG Performance status 0-1.
- Measurable disease per RECIST (1.1).
Key exclusion criteria (8 listed)
- Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening.
- Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.
- Bone as the only site of metastatic disease from breast cancer.
- Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib.
- Pregnancy or lactation.
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 |
|---|---|---|
| ganetespibGanetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle. | Drug | ER/PR+ Refractory to Prior Hormonal Treatment, HER2+ breast cancer, Triple negative breast cancer |
Primary outcome
Objective response rate
Time frame: Week 12
Objective response rate is based on RECIST criteria
1 secondary outcome
Duration of response and progression free survival
Time frame: Every six weeks until progression
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 5 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ganetespib in people with Breast Cancer and HER-2 Positive Breast Cancer, run by Synta Pharmaceuticals Corp. at 25 sites in 8 countries.
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 10 inclusion and 8 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, South Korea, Belgium, Argentina and 3 more countries. 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?
Objective response rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2015.