Non-small Cell Lung Cancer Stage IIIBPhase 2/3GALAXYNCT01348126
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
A Phase 2/3 study testing Docetaxel and Combination of ganetespib and docetaxel in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Synta Pharmaceuticals Corp. at 53 sites in 13 countries.
Trial summary
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Docetaxel and Combination of ganetespib and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 53 sitesin 13 countries
- Study dates
- May 2011to Oct 2015
- Phase
- Phase 2/3
- 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
- confirmed diagnosis of NSCLC
- Stage IIIB or IV NSCLC
- ECOG Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- measurable disease
- Radiologic evidence of disease progression following most recent prior treatment.
- Adequate hematologic, hepatic, renal function
Who cannot join
- Active or untreated CNS metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
Trial locations and contacts
53 sites in 13 countries.
53 sites in 13 countries
United States8 sites
Synta Pharmaceuticals Investigative Site
Atlanta, Georgia, 30322
Synta Pharmaceutials Investigative Site
Boston, Massachusetts, 02215
Synta Pharmaceuticals Investigative Site
Chicago, Illinois, 60637
Synta Pharmaceuticals Investigative Site
Kettering, Ohio, 45429
Synta Pharmaceuticals Investigative Site
Portland, Oregon, 97227
Synta Pharmaceuticals Investigative Site
Santa Monica, California, 90404
Synta Pharmaceuticals Investigative Site
Tucson, Arizona, 85715
Synta Pharmaceuticals Investigative Site
Winston-Salem, North Carolina, 27103
Russia7 sites
Synta Pharmaceuticals Investigative Site
Kazan', 420029
Synta Pharmaceuticals Investigative Site
Moscow, 105229
Synta Pharmaceuticals Investigative Site
Moscow, 115478
Synta Pharmaceuticals Investigative Site
Saint Petersburg, 194075
Synta Pharmaceuticals Investigative Site
Saint Petersburg, 197758
Synta Pharmaceuticals Investigative Site
Sochi, 354057
Synta Pharmaceuticals Investigative Site
Voronezh, 394000
Bosnia and Herzegovina5 sites
Synta Pharmaceuticals Investigative Site
Banja Luka, 78000
Synta Pharmaceuticals Investigative Site
Mostar, 88000
Synta Pharmaceuticals Investgative Site
Sarajevo, 71000
Synta Pharmaceuticals Investigative Site
Sarajevo, 71000
Synta Pharmaceuticals Investigative Site
Tuzla, 75000
Germany5 sites
Synta Pharmaceuticals Investigative Site
Halle, 06120
Synta Pharmaceuticals Investigative Site
Hamburg, 22045
Synta Pharmaceuticals Investigative Site
Mainz, 55131
Synta Pharmaceuticals Investigative Site
Mannheim, 68167
Synta Pharmaceuticals Investigative Site
Offenbach, 63069
Canada4 sites
Synta Pharmaceuticals Investigative Site
Hamilton, L8V 5C2
Synta Pharmaceuticals Investigative Site
Montreal, H3A 1A1
Synta Pharmaceuticals Investigative Site
Montreal, H3G 1A4
Synta Pharmaceuticals Investigative Site
Ottawa, K1H 8L6
Poland4 sites
Synta Pharmaceuticals Investigative Site
Krakow, 31-115
Synta Pharmaceuticals Investigative Site
Olsztyn, 10-357
Synta Pharmaceuticals Investigative Site
Prabuty, 82-550
Synta Pharmaceuticals Investigative Site
Szczecin, 70-891
Romania4 sites
Synta Pharmaceuticals Investigative Site
Cluj-Napoca, 400015
Synta Pharmaceuticals Investigative Site
Cluj-Napoca, 400058
Synta Pharmaceuticals Investigative Site
Craiova, 200385
Synta Pharmaceuticals Investigative Site
Suceava, 720237
United Kingdom4 sites
Synta Pharmaceuticals Investigational Site
Leicester, LE2 7HL
Synta Pharmaceuticals Investigative Site
London, SE1 9RT
Synta Pharmaceuticals Investigational Site
London, SW3 6JJ
Synta Pharmaceuticals Investigational Site
Sutton, SM2 5PT
Belgium3 sites
Synta Pharmaceuticals Investigative Site
Brussels, 1200
Synta Pharmaceuticals Investigative Site
Jette, 1090
Synta Pharmaceuticals Investigative Site
Yvoir, 5530
Croatia3 sites
Synta Pharmaceuticals Investigative Site
Pula, 52100
Synta Pharmaceuticals Investigative Site
Split, 21000
Synta Pharmaceuticals Investigative Site
Zagreb, 10000
Spain3 sites
Synta Pharmaceuticals Investigative Site
Badalona, 08916
Synta Pharmaceuticals Investigative Site
Barcelona, 08035
Synta Pharmaceuticals Investigative Site
Madrid, 28040
Serbia2 sites
Synta Pharmaceuticals Investigative Site
Belgrade, 11000
Synta Pharmaceuticals Investigative Site
Kamenitz, 21204
About this study
Official title: A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.
Read the detailed description
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.
- Conditions
- Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic
- Being tested
- Docetaxel, Combination of ganetespib and docetaxel
- Keywords
- Advanced non-small cell lung cancer, NSCLC, Lung cancer
- 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.
DocetaxelDrug
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
Combination of ganetespib and docetaxelDrug
Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single agent docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Combination of ganetespib and docetaxel | Experimental | Not described Receives: Drug: Combination of ganetespib and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival in two co-primary populations
Measured: 14 months
Secondary outcomes (7)
Overall Response Rate
ORR is the proportion of subjects who achieve tumor response
Measured: 14 months
Determine qualitative and quantitative toxicities
AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned.
Measured: 14 months
Determine plasma drug concentrations of the combination
Assessed via measurement of Cmax levels.
Measured: 14 months
Evaluate Quality of Life
As measured by the EORTC QLQ -C30 questionnaire
Measured: 14 months
Disease Control Rate
Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks.
Measured: 14 months
Tumor size change
Tumor size changes from baseline to at least 6 and 12 weeks
Measured: 14 months
Overall survival
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionOct 2015
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 Cancer Stage IIIBStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 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
- NCT01348126
- Sponsor's protocol ID
- 9090-08
- Acronym
- GALAXY
- Status last verified
- Nov 2015
- First submitted
- 2 May 2011
- 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
- A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01348126
- Acronym / sponsor ID
- GALAXY / 9090-08
- Conditions
- Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic
- Keywords
- Advanced non-small cell lung cancer, NSCLC, Lung cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 May 2011 (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 whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.
Detailed description
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single agent docetaxel | Active comparator | Drug: Docetaxel |
| Combination of ganetespib and docetaxel | Experimental | Drug: Combination of ganetespib and docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- confirmed diagnosis of NSCLC
- Stage IIIB or IV NSCLC
- ECOG Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- measurable disease
Key exclusion criteria (5 listed)
- Active or untreated CNS metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- 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 |
|---|---|---|
| Docetaxel75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion | Drug | Single agent docetaxel |
| Combination of ganetespib and docetaxelGanetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle. | Drug | Combination of ganetespib and docetaxel |
Primary outcome
Progression-free survival in two co-primary populations
Time frame: 14 months
7 secondary outcomes
Overall Response Rate
Time frame: 14 months
Determine qualitative and quantitative toxicities
Time frame: 14 months
Determine plasma drug concentrations of the combination
Time frame: 14 months
Evaluate Quality of Life
Time frame: 14 months
Disease Control Rate
Time frame: 14 months
Tumor size change
Time frame: 14 months
Overall survival
Time frame: 21 months
Results and safety
The study was stopped early. Results are not available in the source record.
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.
53 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docetaxel and Combination of ganetespib and docetaxel in people with Non-small Cell Lung Cancer Stage IIIB and Non-small Cell Lung Cancer Stage IV, run by Synta Pharmaceuticals Corp. at 53 sites in 13 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 7 inclusion and 5 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: stopped early, 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 53 sites in United States, Russia, Bosnia and Herzegovina, Germany, Canada and 8 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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 in two co-primary populations (time frame: 14 months). 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.