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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01082549
First received: March 5, 2010
Last updated: September 14, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Squamous Cell Lung Cancer
Drug: gemcitabine/carboplatin
Drug: gemcitabine/carboplatin plus Iniparib
Phase 3

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • overall survival [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gemcitabine/carboplatin Drug: gemcitabine/carboplatin
i.v.
Experimental: gemcitabine/carboplatin plus Iniparib Drug: gemcitabine/carboplatin plus Iniparib
i.v.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082549

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01082549     History of Changes
Other Study ID Numbers: EFC11553, 20090321
Study First Received: March 5, 2010
Last Updated: September 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Patients with Previously Untreated Advanced Squamous Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 10, 2014