Non Small Cell Lung CancerPhase 2NCT01031225
A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing STA 9090 in people with Non Small Cell Lung Cancer, run by Synta Pharmaceuticals Corp. at 21 sites in United States.
Trial summary
This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung 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
- 113 participants
- Where
- 21 sitesUnited States
- Study dates
- Nov 2009to Feb 2014
- 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
- Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
- Availability of tissue for analysis
- ECOG Performance Status 0 or 1
- Adequate organ function as defined in the protocol.
- Must be at least 18 years old and able and willing to sign a written informed consent document
Who cannot join
- Poor venous access requiring an indwelling catheter for study drug administration
- Women who are pregnant or lactating
- Ventricular ejection fraction < or = to 55% at baseline
- Any uncontrolled intercurrent illness
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University- Winship Cancer Institute
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
City of Hope Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Oregon Health and Science University
Portland, Oregon, 97239
UCLA Health System
Santa Monica, California, 90404
Swedish Medical Center
Seattle, Washington, 98104
Arizona Cancer Center; University of Arizona
Tucson, Arizona, 85724
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer
This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- STA 9090
- Keywords
- Synta, STA 9090, ganetespib), Lung Cancer, Non Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA 9090Drug
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: STA 9090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival rate
Measured: 16 weeks
Secondary outcomes (2)
Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
Measured: 18 months
Safety and tolerability as measured by adverse event rates and laboratory evaluations
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- 113 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
- NCT01031225
- Sponsor's protocol ID
- 9090-06
- Status last verified
- Sep 2014
- First submitted
- 16 Nov 2009
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01031225
- Acronym / sponsor ID
- 9090-06
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Synta, STA 9090, ganetespib), Lung Cancer, Non Small Cell Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Dec 2009 (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.
This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: STA 9090 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
- Availability of tissue for analysis
- ECOG Performance Status 0 or 1
- Adequate organ function as defined in the protocol.
- Must be at least 18 years old and able and willing to sign a written informed consent document
Key exclusion criteria (4 listed)
- Poor venous access requiring an indwelling catheter for study drug administration
- Women who are pregnant or lactating
- Ventricular ejection fraction < or = to 55% at baseline
- Any uncontrolled intercurrent illness
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 9090STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval | Drug | 1 |
Primary outcome
Progression Free Survival rate
Time frame: 16 weeks
2 secondary outcomes
Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
Time frame: 18 months
Safety and tolerability as measured by adverse event rates and laboratory evaluations
Time frame: 16 months
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 19 Sep 2014.
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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.
21 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 Non Small Cell Lung Cancer, run by Synta Pharmaceuticals Corp. at 21 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 5 inclusion and 4 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Progression Free Survival rate (time frame: 16 weeks). 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 19 Sep 2014.