Non Small Cell Lung CancerPhase 2NCT01362400
A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing IPI 504 plus Docetaxel in people with Non Small Cell Lung Cancer, run by Infinity Pharmaceuticals, Inc. at 65 sites in 6 countries.
Trial summary
The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for 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?
- IPI 504 plus Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 65 sitesin 6 countries
- Study dates
- May 2011to Apr 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
- Patients must be ≥18 years of age
- Voluntarily signed an informed consent
- Confirmed NSCLC and Stage IIIB or IV disease.
- At least a ≥15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.
- Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
- Must have experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
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- Must have received no more than 2 prior chemotherapy regimens
- Measurable disease by RECIST 1.1 criteria.
- ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).
- Women of child-bearing potential (WCBP), all sexually active male patients, and partners of patients must agree to use adequate methods of birth control.
Who cannot join
- Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment
- Known hypersensitivity to drugs formulated with polysorbate-80.
- Not recovered from any toxicities related to prior treatment
- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer
- Inadequate hematologic function
- Inadequate hepatic function
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- Inadequate renal function
- Symptomatic keratitis or keratoconjunctivitis.
- Uncontrolled systemic fungal, bacterial, viral or other infection
- Patients with clinically active brain metastases
- Patients with clinically stable brain metastases (previously treated or untreated) are eligible.
- Sinus bradycardia (resting heart rate <50 bpm).
- Significant cardiac disease
- Previous or current malignancies at other sites within the last 2 years
- Prior hepatic resections or hepatic-directed therapy
- Known HIV-positive patients receiving combination antiretroviral therapy.
- Women who are pregnant or lactating.
Trial locations and contacts
65 sites in 6 countries.
65 sites in 6 countries
United States41 sites
Ann Arbor Hematology Oncology Associates
Ann Arbor, Michigan, 48158
Texas Oncology-Arlington South
Arlington, Texas, 76014
Massachusetts General Hospital
Boston, Massachusetts, 02114
Central Indiana Cancer Centers
Carmel, Indiana, 46032
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414
Blumenthal Cancer Center
Charlotte, North Carolina, 28203
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
Puget Sound Cancer Centers
Edmonds, Washington, 98026
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Florida Cancer Specialists
Fort Myers, Florida, 33916
Indiana University
Indianapolis, Indiana, 46202
Broome Oncology, LLC
Johnson City, New York, 13790
Sparrow Regional Cancer Center
Lansing, Michigan, 48912
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510
Owsley Brown Frazier Cancer Center-Louisville Downtown
Louisville, Kentucky, 40215
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303
Community Hospital
Munster, Indiana, 46321
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, 47150
Yale Cancer Center
New Haven, Connecticut, 06519
Tulane University
New Orleans, Louisiana, 70112
Memorial Sloan-Kettering Cancer Center
New York, New York, 14642
University of California Irvine Medical Center
Orange, California, 92868
PMK Medical Group, Inc.
Oxnard, California, 93030
Providence Portland Medical Center
Portland, Oregon, 97213
Wilshire Oncology Medical Group, Inc.
Rancho Cucamonga, California, 91730
Virginia Cancer Institute
Richmond, Virginia, 23230
University of Rochester
Rochester, New York, 14642
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84112
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705
Arizona Oncology Associates
Tucson, Arizona, 85715-4900
Texas Oncology-Tyler
Tyler, Texas, 75702
American Institute of Research
Whittier, California, 90603
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, 27103
Metro Health Cancer Center
Wyoming, Michigan, 49519
Hungary6 sites
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1121
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1529
Pándy Kálmán Megyei Kórház
Gyula, Bekes County, 5703
Mátrai Gyógyintézet
Mátraháza, Heves County, 3233
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
Sopron, Győr-Moson-Sopron, 9400
Zala Megyei Kórház
Zalaegerszeg, Zala County, 8900
South Korea6 sites
Dong-A University Medical Center
Busan, 602-715
National Cancer Center
Goyang-si, Gyeonggi-do, 411-769
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-763
Inha University Hospital
Jung Gu, Incheon, 400-711
Severance Hospital,Yonsei University Health System
Seoul, 120-752
Asan Medical Center
Seoul, 138-876
Romania4 sites
Spitalul de Urgenta "Constantin Opris"
Baia Mare, Maramureş, 430031
Institutul Oncologic "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Cluj, 400015
Spitalul Municipal Ploiesti
Ploieşti, Prahova, 100337
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Sibiu County, 500245
Russia4 sites
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, 454087
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
Moscow, 115478
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
Moscow, 129128
City Oncology Hospital # 62
Moscow Region, Moscow, 143423
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Tri-Service General Hospital
Taipei, 11490
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer
Read the detailed description
This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- IPI 504 plus Docetaxel, Placebo plus Docetaxel
- Keywords
- LUNG NEOPLASMS, LARGE CELL CARCINOMA, SQUAMOUS CELL CARCINOMA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Large Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI 504 plus DocetaxelDrug
Also called IPI-504, Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Placebo plus DocetaxelDrug
Also called Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: IPI 504 + Docetaxel | Active comparator | Drug: IPI-504 plus Docetaxel Receives: Drug: IPI 504 plus Docetaxel |
| Placebo + Docetaxel | Placebo comparator | Placebo plus Docetaxel Receives: Drug: Placebo plus Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Measured: Up to three years from last patient study visit
Secondary outcomes (3)
Progression Free Survival
To determine the progression free survival rate from randomization to progression or death whichever occurs first, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Measured: Up to three years from last patient study visit
Overall Response Rate
To determine partial response or complete response occurring at any point post-treatment
Measured: Up to three years from last patient study visit
Time to Progression
To identify the amount of time from randomization to progression, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Measured: Up to three years from last patient study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tess Schmalbach, MD, Study director, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362400
- Sponsor's protocol ID
- IPI 504-14
- Status last verified
- May 2014
- First submitted
- 26 May 2011
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01362400
- Acronym / sponsor ID
- IPI 504-14
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- LUNG NEOPLASMS, LARGE CELL CARCINOMA, SQUAMOUS CELL CARCINOMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 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 compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer
Detailed description
This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1: IPI 504 + Docetaxel | Active comparator | Drug: IPI 504 plus DocetaxelDrug: IPI-504 plus Docetaxel |
| Placebo + Docetaxel | Placebo comparator | Drug: Placebo plus DocetaxelPlacebo plus Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must be ≥18 years of age
- Voluntarily signed an informed consent
- Confirmed NSCLC and Stage IIIB or IV disease.
- At least a ≥15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.
- Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
Key exclusion criteria (17 listed)
- Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment
- Known hypersensitivity to drugs formulated with polysorbate-80.
- Not recovered from any toxicities related to prior treatment
- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer
- Inadequate hematologic function
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 |
|---|---|---|
| IPI 504 plus DocetaxelAlso: IPI-504, Docetaxel450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) | Drug | ARM 1: IPI 504 + Docetaxel |
| Placebo plus DocetaxelAlso: Docetaxel450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle 75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle) | Drug | Placebo + Docetaxel |
Primary outcome
Overall Survival
Time frame: Up to three years from last patient study visit
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
3 secondary outcomes
Progression Free Survival
Time frame: Up to three years from last patient study visit
Overall Response Rate
Time frame: Up to three years from last patient study visit
Time to Progression
Time frame: Up to three years from last patient study visit
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 May 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.
Tess Schmalbach, MD study director
Infinity Pharmaceuticals, Inc.
65 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI 504 plus Docetaxel in people with Non Small Cell Lung Cancer, run by Infinity Pharmaceuticals, Inc. at 65 sites in 6 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 17 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Hungary, South Korea, Romania, Russia and 1 more country. 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. Some participants in this study may receive a placebo. 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?
Overall Survival (time frame: Up to three years from last patient study visit). 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 May 2014.