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ECLIPSE: 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)

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01082549
Collaborator
(none)
780
Enrollment
142
Locations
2
Arms
37
Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
780 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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)
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: gemcitabine/carboplatin

Drug: gemcitabine/carboplatin
i.v.
Experimental: gemcitabine/carboplatin plus Iniparib

Drug: gemcitabine/carboplatin plus Iniparib
i.v.

Outcome Measures

Primary Outcome Measures

  1. overall survival [12 months, 24 months]

Secondary Outcome Measures

  1. progression free survival [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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.

  2. 18 years of age.

  3. Ability to understand the nature of this study, give written informed consent, and comply with study requirements.

  4. 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.

  1. 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.

  2. Women who are pregnant or lactating.

  3. Any serious, active infection (> Grade 2) at the time of treatment.

  4. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.

  5. 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.

  6. 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.

  7. 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.

  8. 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

Locations

Site City State Country Postal Code
1 Investigational Site Number 840306 Birmingham Alabama United States 35205
2 Investigational Site Number 840207 Huntsville Alabama United States 35805
3 Investigational Site Number 840351 Muscle Shoals Alabama United States 35661
4 Investigational Site Number 840338 Anaheim California United States 92801
5 Investigational Site Number 840353 Burbank California United States 91505
6 Investigational Site Number 840341 Concord California United States 73112
7 Investigational Site Number 840317 Duarte California United States 91010
8 Investigational Site Number 840339 La Verne California United States 91750
9 Investigational Site Number 840309 Loma Linda California United States 92354
10 Investigational Site Number 840307 Los Angeles California United States 90095-7059
11 Investigational Site Number 840327 Maywood California United States 60153
12 Investigational Site Number 840303 San Diego California United States 92123
13 Investigational Site Number 840321 Santa Rosa California United States 95403
14 Investigational Site Number 840326 Stockton California United States 95204
15 Investigational Site Number 840310 Vallejo California United States 94589
16 Investigational Site Number 840336 Denver Colorado United States 80205
17 Investigational Site Number 840346 Norwich Connecticut United States 06360
18 Investigational Site Number 840315 Newark Delaware United States 19713
19 Investigational Site Number 840216 Ft. Lauderdale Florida United States 33308
20 Investigational Site Number 840215 Jacksonville Florida United States 32256
21 Investigational Site Number 840217 Lakeland Florida United States 33805
22 Investigational Site Number 840205 Orlando Florida United States 32804
23 Investigational Site Number 840104 Sarasota Florida United States 34236
24 Investigational Site Number 840343 Athens Georgia United States 30607
25 Investigational Site Number 840213 Augusta Georgia United States 30901
26 Investigational Site Number 840347 Augusta Georgia United States 30901
27 Investigational Site Number 840201 Gainesville Georgia United States 30501
28 Investigational Site Number 840301 Lawrenceville Georgia United States 30045
29 Investigational Site Number 840305 Marietta Georgia United States 30060
30 Investigational Site Number 840314 Tucker Georgia United States 30084
31 Investigational Site Number 840313 Chicago Illinois United States 60637
32 Investigational Site Number 840218 Evansville Indiana United States 47630
33 Investigational Site Number 840319 Indianapolis Indiana United States 46260
34 Investigational Site Number 840329 South Bend Indiana United States 46601
35 Investigational Site Number 840316 Wichita Kansas United States 67214
36 Investigational Site Number 840320 Louisville Kentucky United States 40202
37 Investigational Site Number 840308 Scarborough Maine United States 04074-9308
38 Investigational Site Number 840202 Bethesda Maryland United States 20817
39 Investigational Site Number 840345 Salisbury Maryland United States 21801
40 Investigational Site Number 840337 Royal Oak Michigan United States 48073
41 Investigational Site Number 840328 St. Louis Park Minnesota United States 55426
42 Investigational Site Number 840210 Bridgeton Missouri United States 63044
43 Investigational Site Number 840212 Omaha Nebraska United States 68114
44 Investigational Site Number 840318 Las Vegas Nevada United States 89135
45 Investigational Site Number 840204 Morristown New Jersey United States 07960
46 Investigational Site Number 840350 Chapel Hill North Carolina United States 27599
47 Investigational Site Number 840330 Durham North Carolina United States 27710
48 Investigational Site Number 840105 Cincinnati Ohio United States 45242
49 Investigational Site Number 840302 Cleveland Ohio United States 44106
50 Investigational Site Number 840348 Cleveland Ohio United States 44195
51 Investigational Site Number 840335 Columbus Ohio United States 43219
52 Investigational Site Number 840311 Bend Oregon United States 97701
53 Investigational Site Number 840211 West Reading Pennsylvania United States 19611
54 Investigational Site Number 840352 Charleston South Carolina United States 29403
55 Investigational Site Number 840106 Columbia South Carolina United States 29210
56 Investigational Site Number 840220 Spartanburg South Carolina United States 29303
57 Investigational Site Number 840103 Chattanooga Tennessee United States 37404
58 Investigational Site Number 840208 Chattanooga Tennessee United States 37404
59 Investigational Site Number 840203 Collierville Tennessee United States 38017
60 Investigational Site Number 840101 Nashville Tennessee United States 37203
61 Investigational Site Number 840323 Fort Worth Texas United States 76104
62 Investigational Site Number 840219 Newport News Virginia United States 23601
63 Investigational Site Number 840102 Richmond Virginia United States 23230
64 Investigational Site Number 840312 Seattle Washington United States 98104
65 Investigational Site Number 840344 Tacoma Washington United States 98405
66 Investigational Site Number 840322 Morgantown West Virginia United States 26506
67 Investigational Site Number 840331 Wauwatosa Wisconsin United States 53226
68 Investigational Site Number 056004 Brugge Belgium 8310
69 Investigational Site Number 056003 Brussel Belgium 1090
70 Investigational Site Number 056001 Liège Belgium 4000
71 Investigational Site Number 124003 Edmonton Canada T6G 1Z2
72 Investigational Site Number 124006 Greenfield Park Canada J4V 2H1
73 Investigational Site Number 124005 London Canada N6A 4L6
74 Investigational Site Number 124007 Oshawa Canada L1G 2B9
75 Investigational Site Number 124004 Quebec Canada G1V 4G5
76 Investigational Site Number 124001 Toronto Canada M5G 2M9
77 Investigational Site Number 250007 Brest France 29609
78 Investigational Site Number 250002 Dijon France 21034
79 Investigational Site Number 250009 Limoges Cedex France 87042
80 Investigational Site Number 250003 Marseille France 13008
81 Investigational Site Number 250004 Paris Cedex 13 France 75651
82 Investigational Site Number 250010 Pierre Benite Cedex France 69495
83 Investigational Site Number 250008 Poitiers France 86021
84 Investigational Site Number 250001 Saint-Herblain Cedex France 44805
85 Investigational Site Number 250006 Strasbourg France 67100
86 Investigational Site Number 250005 Tours Cedex 1 France 37044
87 Investigational Site Number 276002 Amberg Germany 92224
88 Investigational Site Number 276004 Berlin Germany 13125
89 Investigational Site Number 276007 Frankfurt Am Main Germany 60488
90 Investigational Site Number 276008 Großhansdorf Germany 22927
91 Investigational Site Number 276010 Halle/Saale Germany 06120
92 Investigational Site Number 276012 Heidelberg Germany 69126
93 Investigational Site Number 276009 Immenhausen Germany 34376
94 Investigational Site Number 276001 Löwenstein Germany 74245
95 Investigational Site Number 276006 München Germany 80336
96 Investigational Site Number 276003 Oldenburg Germany 26121
97 Investigational Site Number 348005 Budapest Hungary 1121
98 Investigational Site Number 348003 Budapest Hungary 1529
99 Investigational Site Number 348001 Mátraháza Hungary 3233
100 Investigational Site Number 348004 Nyíregyháza Hungary 4400
101 Investigational Site Number 376002 Kfar Saba Israel 44281
102 Investigational Site Number 376005 Petah-Tikva Israel 49100
103 Investigational Site Number 376003 Tel Hashomer Israel 52621
104 Investigational Site Number 376001 Tzrifin Israel 70300
105 Investigational Site Number 380006 Genova Italy 16132
106 Investigational Site Number 380001 Novara Italy 28100
107 Investigational Site Number 380008 Orbassano Italy 10043
108 Investigational Site Number 380002 Perugia Italy 06128
109 Investigational Site Number 380003 Roma Italy 00149
110 Investigational Site Number 380007 Roma Italy 00189
111 Investigational Site Number 442001 Luxembourg Luxembourg 1210
112 Investigational Site Number 528005 Breda Netherlands 4818 CK
113 Investigational Site Number 528004 Eindhoven Netherlands 5623 EJ
114 Investigational Site Number 528001 Groningen Netherlands 9713 GZ
115 Investigational Site Number 528006 Maastricht Netherlands 6229 HX
116 Investigational Site Number 528003 Zwolle Netherlands 8011 JW
117 Investigational Site Number 616006 Bialystok Poland 15-069
118 Investigational Site Number 616001 Krakow Poland 31 -202
119 Investigational Site Number 616007 Lubin Poland 59-300
120 Investigational Site Number 616004 Olsztyn Poland 10-228
121 Investigational Site Number 616008 Torun Poland 87-100
122 Investigational Site Number 616002 Warszawa Poland 02-781
123 Investigational Site Number 616005 Wroclaw Poland 53-439
124 Investigational Site Number 642002 Alba Iulia Romania 510077
125 Investigational Site Number 642006 Bucuresti Romania 022328
126 Investigational Site Number 642001 Cluj Napoca Romania 400015
127 Investigational Site Number 642004 Craiova Romania 200385
128 Investigational Site Number 642005 Hunedoara Romania 331057
129 Investigational Site Number 724009 Badalona Spain 08916
130 Investigational Site Number 724003 Barcelona Spain 08035
131 Investigational Site Number 724004 La Coruña Spain 15006
132 Investigational Site Number 724005 Madrid Spain 28034
133 Investigational Site Number 724006 Madrid Spain 28041
134 Investigational Site Number 724002 Málaga Spain 29011
135 Investigational Site Number 724001 Palma De Mallorca Spain 07198
136 Investigational Site Number 724008 Sevilla Spain 41013
137 Investigational Site Number 724010 Valencia Spain 46014
138 Investigational Site Number 724007 Zaragoza Spain 50009
139 Investigational Site Number 826002 Glasgow United Kingdom G12 0YN
140 Investigational Site Number 826005 Leeds United Kingdom LS9 7TF
141 Investigational Site Number 826001 Manchester United Kingdom M20 4BX
142 Investigational Site Number 826006 Wolverhampton United Kingdom WV10 0QP

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT01082549
Other Study ID Numbers:
  • EFC11553
  • 20090321
First Posted:
Mar 8, 2010
Last Update Posted:
Mar 17, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Sanofi
Patients with Previously Untreated Advanced Squamous Cell Lung Cancer
Additional relevant MeSH terms:
Lung Neoplasms
Gemcitabine
Carboplatin
Iniparib

Study Results

No Results Posted as of Mar 17, 2016