Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) (ECLIPSE)

February 17, 2016 updated by: Sanofi

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

780

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8310
        • Investigational Site Number 056004
      • Brussel, Belgium, 1090
        • Investigational Site Number 056003
      • Liège, Belgium, 4000
        • Investigational Site Number 056001
  • Canada
      • Edmonton, Canada, T6G 1Z2
        • Investigational Site Number 124003
      • Greenfield Park, Canada, J4V 2H1
        • Investigational Site Number 124006
      • London, Canada, N6A 4L6
        • Investigational Site Number 124005
      • Oshawa, Canada, L1G 2B9
        • Investigational Site Number 124007
      • Quebec, Canada, G1V 4G5
        • Investigational Site Number 124004
      • Toronto, Canada, M5G 2M9
        • Investigational Site Number 124001
  • France
      • Brest, France, 29609
        • Investigational Site Number 250007
      • Dijon, France, 21034
        • Investigational Site Number 250002
      • Limoges Cedex, France, 87042
        • Investigational Site Number 250009
      • Marseille, France, 13008
        • Investigational Site Number 250003
      • Paris Cedex 13, France, 75651
        • Investigational Site Number 250004
      • Pierre Benite Cedex, France, 69495
        • Investigational Site Number 250010
      • Poitiers, France, 86021
        • Investigational Site Number 250008
      • Saint-Herblain Cedex, France, 44805
        • Investigational Site Number 250001
      • Strasbourg, France, 67100
        • Investigational Site Number 250006
      • Tours Cedex 1, France, 37044
        • Investigational Site Number 250005
  • Germany
      • Amberg, Germany, 92224
        • Investigational Site Number 276002
      • Berlin, Germany, 13125
        • Investigational Site Number 276004
      • Frankfurt Am Main, Germany, 60488
        • Investigational Site Number 276007
      • Großhansdorf, Germany, 22927
        • Investigational Site Number 276008
      • Halle/Saale, Germany, 06120
        • Investigational Site Number 276010
      • Heidelberg, Germany, 69126
        • Investigational Site Number 276012
      • Immenhausen, Germany, 34376
        • Investigational Site Number 276009
      • Löwenstein, Germany, 74245
        • Investigational Site Number 276001
      • München, Germany, 80336
        • Investigational Site Number 276006
      • Oldenburg, Germany, 26121
        • Investigational Site Number 276003
  • Hungary
      • Budapest, Hungary, 1121
        • Investigational Site Number 348005
      • Budapest, Hungary, 1529
        • Investigational Site Number 348003
      • Mátraháza, Hungary, 3233
        • Investigational Site Number 348001
      • Nyíregyháza, Hungary, 4400
        • Investigational Site Number 348004
  • Israel
      • Kfar Saba, Israel, 44281
        • Investigational Site Number 376002
      • Petah-Tikva, Israel, 49100
        • Investigational Site Number 376005
      • Tel Hashomer, Israel, 52621
        • Investigational Site Number 376003
      • Tzrifin, Israel, 70300
        • Investigational Site Number 376001
  • Italy
      • Genova, Italy, 16132
        • Investigational Site Number 380006
      • Novara, Italy, 28100
        • Investigational Site Number 380001
      • Orbassano, Italy, 10043
        • Investigational Site Number 380008
      • Perugia, Italy, 06128
        • Investigational Site Number 380002
      • Roma, Italy, 00149
        • Investigational Site Number 380003
      • Roma, Italy, 00189
        • Investigational Site Number 380007
  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Investigational Site Number 442001
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Investigational Site Number 528005
      • Eindhoven, Netherlands, 5623 EJ
        • Investigational Site Number 528004
      • Groningen, Netherlands, 9713 GZ
        • Investigational Site Number 528001
      • Maastricht, Netherlands, 6229 HX
        • Investigational Site Number 528006
      • Zwolle, Netherlands, 8011 JW
        • Investigational Site Number 528003
  • Poland
      • Bialystok, Poland, 15-069
        • Investigational Site Number 616006
      • Krakow, Poland, 31 -202
        • Investigational Site Number 616001
      • Lubin, Poland, 59-300
        • Investigational Site Number 616007
      • Olsztyn, Poland, 10-228
        • Investigational Site Number 616004
      • Torun, Poland, 87-100
        • Investigational Site Number 616008
      • Warszawa, Poland, 02-781
        • Investigational Site Number 616002
      • Wroclaw, Poland, 53-439
        • Investigational Site Number 616005
  • Romania
      • Alba Iulia, Romania, 510077
        • Investigational Site Number 642002
      • Bucuresti, Romania, 022328
        • Investigational Site Number 642006
      • Cluj Napoca, Romania, 400015
        • Investigational Site Number 642001
      • Craiova, Romania, 200385
        • Investigational Site Number 642004
      • Hunedoara, Romania, 331057
        • Investigational Site Number 642005
  • Spain
      • Badalona, Spain, 08916
        • Investigational Site Number 724009
      • Barcelona, Spain, 08035
        • Investigational Site Number 724003
      • La Coruña, Spain, 15006
        • Investigational Site Number 724004
      • Madrid, Spain, 28034
        • Investigational Site Number 724005
      • Madrid, Spain, 28041
        • Investigational Site Number 724006
      • Málaga, Spain, 29011
        • Investigational Site Number 724002
      • Palma De Mallorca, Spain, 07198
        • Investigational Site Number 724001
      • Sevilla, Spain, 41013
        • Investigational Site Number 724008
      • Valencia, Spain, 46014
        • Investigational Site Number 724010
      • Zaragoza, Spain, 50009
        • Investigational Site Number 724007
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Investigational Site Number 826002
      • Leeds, United Kingdom, LS9 7TF
        • Investigational Site Number 826005
      • Manchester, United Kingdom, M20 4BX
        • Investigational Site Number 826001
      • Wolverhampton, United Kingdom, WV10 0QP
        • Investigational Site Number 826006
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 840306
      • Huntsville, Alabama, United States, 35805
        • Investigational Site Number 840207
      • Muscle Shoals, Alabama, United States, 35661
        • Investigational Site Number 840351
    • California
      • Anaheim, California, United States, 92801
        • Investigational Site Number 840338
      • Burbank, California, United States, 91505
        • Investigational Site Number 840353
      • Concord, California, United States, 73112
        • Investigational Site Number 840341
      • Duarte, California, United States, 91010
        • Investigational Site Number 840317
      • La Verne, California, United States, 91750
        • Investigational Site Number 840339
      • Loma Linda, California, United States, 92354
        • Investigational Site Number 840309
      • Los Angeles, California, United States, 90095-7059
        • Investigational Site Number 840307
      • Maywood, California, United States, 60153
        • Investigational Site Number 840327
      • San Diego, California, United States, 92123
        • Investigational Site Number 840303
      • Santa Rosa, California, United States, 95403
        • Investigational Site Number 840321
      • Stockton, California, United States, 95204
        • Investigational Site Number 840326
      • Vallejo, California, United States, 94589
        • Investigational Site Number 840310
    • Colorado
      • Denver, Colorado, United States, 80205
        • Investigational Site Number 840336
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Investigational Site Number 840346
    • Delaware
      • Newark, Delaware, United States, 19713
        • Investigational Site Number 840315
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • Investigational Site Number 840216
      • Jacksonville, Florida, United States, 32256
        • Investigational Site Number 840215
      • Lakeland, Florida, United States, 33805
        • Investigational Site Number 840217
      • Orlando, Florida, United States, 32804
        • Investigational Site Number 840205
      • Sarasota, Florida, United States, 34236
        • Investigational Site Number 840104
    • Georgia
      • Athens, Georgia, United States, 30607
        • Investigational Site Number 840343
      • Augusta, Georgia, United States, 30901
        • Investigational Site Number 840213
      • Augusta, Georgia, United States, 30901
        • Investigational Site Number 840347
      • Gainesville, Georgia, United States, 30501
        • Investigational Site Number 840201
      • Lawrenceville, Georgia, United States, 30045
        • Investigational Site Number 840301
      • Marietta, Georgia, United States, 30060
        • Investigational Site Number 840305
      • Tucker, Georgia, United States, 30084
        • Investigational Site Number 840314
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Investigational Site Number 840313
    • Indiana
      • Evansville, Indiana, United States, 47630
        • Investigational Site Number 840218
      • Indianapolis, Indiana, United States, 46260
        • Investigational Site Number 840319
      • South Bend, Indiana, United States, 46601
        • Investigational Site Number 840329
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Investigational Site Number 840316
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Investigational Site Number 840320
    • Maine
      • Scarborough, Maine, United States, 04074-9308
        • Investigational Site Number 840308
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Investigational Site Number 840202
      • Salisbury, Maryland, United States, 21801
        • Investigational Site Number 840345
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Investigational Site Number 840337
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55426
        • Investigational Site Number 840328
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Investigational Site Number 840210
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Investigational Site Number 840212
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Investigational Site Number 840318
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Investigational Site Number 840204
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Investigational Site Number 840350
      • Durham, North Carolina, United States, 27710
        • Investigational Site Number 840330
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Investigational Site Number 840105
      • Cleveland, Ohio, United States, 44106
        • Investigational Site Number 840302
      • Cleveland, Ohio, United States, 44195
        • Investigational Site Number 840348
      • Columbus, Ohio, United States, 43219
        • Investigational Site Number 840335
    • Oregon
      • Bend, Oregon, United States, 97701
        • Investigational Site Number 840311
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Investigational Site Number 840211
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Investigational Site Number 840352
      • Columbia, South Carolina, United States, 29210
        • Investigational Site Number 840106
      • Spartanburg, South Carolina, United States, 29303
        • Investigational Site Number 840220
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 840103
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 840208
      • Collierville, Tennessee, United States, 38017
        • Investigational Site Number 840203
      • Nashville, Tennessee, United States, 37203
        • Investigational Site Number 840101
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Investigational Site Number 840323
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Investigational Site Number 840219
      • Richmond, Virginia, United States, 23230
        • Investigational Site Number 840102
    • Washington
      • Seattle, Washington, United States, 98104
        • Investigational Site Number 840312
      • Tacoma, Washington, United States, 98405
        • Investigational Site Number 840344
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Investigational Site Number 840322
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Investigational Site Number 840331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligible patients must meet the following criteria to be enrolled in the study:

  1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system).
  2. Patients who have received prior adjuvant therapy for early-stage lung cancer are eligible if at least 12 months have elapsed from that treatment.
  3. Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors contain mixed non-small cell histologies are eligible, as long as squamous carcinoma is the predominant histology. Mixed tumors with small cell anaplastic elements are not eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable.
  4. Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to the initiation of study treatment. Patients who have received chemo/radiation for locally advanced NSCLC are not eligible. Patients who have received palliative radiation therapy for symptomatic metastases must have completed treatment >14 days prior the initiation of the study treatment.
  5. Presence of evaluable (measureable or non-measurable) disease.
  6. ECOG Performance Status of 0 or 1.

  7. Laboratory values as follows:

    • Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (≤72 hours prior to initial treatment).
    • Hemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin to maintain or exceed this level).
    • Bilirubin < ULN.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement.
    • Creatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the Cockcroft-Gault method.
  8. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Sexually active men must agree to use a medically acceptable form of birth control during treatment and at least 6 months after the last dose. If a female partner becomes pregnant during the course of the study the treating physician should be informed immediately.
  9. >18 years of age.
  10. Ability to understand the nature of this study, give written informed consent, and comply with study requirements.
  11. Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. An exception to this is when the national/local regulations prohibits some of the key activities of this research like the export of samples to third countries, storage of coded samples or global gene expression profiling without a pre-specified list of target genes. If tissue is not available, a patient will still be eligible for enrollment into the study.

Exclusion Criteria:

  1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or Iniparib.
  2. Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of any primary site, or invasive cancers treated definitively, with treatment ending >5 years previously and no evidence of recurrences.

  3. A history of cardiac disease, as defined by:

    • Malignant hypertension
    • Unstable angina
    • Congestive heart failure
    • Myocardial infarction within the previous 6 months
    • Symptomatic, unstable or uncontrolled, cardiac arrhythmias. Patients who have stable, rate-controlled atrial fibrillation are eligible for study enrollment.
  4. Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up scan shows no disease progression; and (3) patient does not require steroids.
  5. Women who are pregnant or lactating.
  6. Any serious, active infection (> Grade 2) at the time of treatment.
  7. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  8. A major surgical procedure, or significant traumatic injury ≤28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  9. Uncontrolled or intercurrent illness including, that in the opinion of the investigator may increase the risks associated with study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
  10. History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
  11. Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gemcitabine/carboplatin
Drug: gemcitabine/carboplatin
i.v.
Experimental: gemcitabine/carboplatin plus Iniparib
Drug: gemcitabine/carboplatin plus Iniparib
i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 12 months, 24 months
12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 8, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC11553
  • 20090321 (OTHER: Hallym Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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