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SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01086254
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

  • to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin (GC) in patients with stage IV non small cell lung cancer.

Secondary objectives are:

  • to assess the safety profiles of the study combination GCS and of the standard regimen GC;
  • to assess the progression free survival and the overall survival in both arms;
  • to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease.
  • to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Stage IV Drug: Iniparib Drug: gemcitabine Drug: cisplatin Phase 2

Detailed Description:

The duration of the study for a patient will include a period for inclusion of up to 3 weeks. The patients may continue treatment up to a maximum of 6 cycles or until disease progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment administration.

Patients will be followed for at least 30 days after the last administration of study treatment for safety purpose. In case of study treatment discontinuation without disease progression, efficacy data will be collected every 6 weeks until disease progression, death or end of study whatever comes first. After disease progression, the patient will be followed-up every 12 weeks (3 months) for overall survival (OS) until death or end of study whatever comes first.

The end of the study will be one year after the first dose of the last treated patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iniparib/ Gemcitabine/ Cisplatin

Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration.

Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion.

Drug: Iniparib

Pharmaceutical form: solution for infusion

Route of administration: 60-minute IV infusion

Other Names:
  • SAR240550
  • BSI-201

Drug: gemcitabine

Pharmaceutical form: solution for infusion

Route of administration: 30-minute IV infusion


Drug: cisplatin

Pharmaceutical form: solution for infusion

Route of administration: 1- to 4-hour IV infusion, according to the local standard


Active Comparator: Gemcitabine/ Cisplatin
Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion.
Drug: gemcitabine

Pharmaceutical form: solution for infusion

Route of administration: 30-minute IV infusion


Drug: cisplatin

Pharmaceutical form: solution for infusion

Route of administration: 1- to 4-hour IV infusion, according to the local standard





Primary Outcome Measures :
  1. overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate [ Time Frame: up to a maximum follow-up of 25 weeks ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: up to a maximum of 2 years ]
  2. overall survival [ Time Frame: up to a maximum of 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Stage IV disease (including stage IIIB with pleural effusion) with no prior systemic therapy. Adjuvant therapy is allowed if ended more than 1 year before inclusion in the study.
  • Histologically confirmed squamous cell bronchogenic carcinoma OR non squamous cell carcinoma.
  • Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to study entry.
  • Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Irradiated lesions may not serve as measurable lesions.
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate bone marrow reserve.
  • Adequate liver and renal function.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment.

Exclusion criteria:

  • Prior treatment with gemcitabine, platinum salts or any PARP inhibitor class compound.
  • 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 the cervix, or other cancers cured by local therapy alone and with an expected disease-free survival of > or = 5 years.
  • Major medical conditions that might affect study participation e.g. cardiac disease, uncontrolled infection (>Grade 2).
  • Presence of active brain metastases.
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  • Any history of 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
  • Grade 2 or higher ear and labyrinth disorders.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086254


Locations
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France
Sanofi-Aventis Investigational Site Number 250002
Caen Cedex, France, 14033
Sanofi-Aventis Investigational Site Number 250003
Marseille Cedex 09, France, 13009
Sanofi-Aventis Investigational Site Number 250004
Toulouse, France, 31059
Sanofi-Aventis Investigational Site Number 250001
Villejuif, France, 94805
Germany
Sanofi-Aventis Investigational Site Number 276003
Essen, Germany, 45122
Sanofi-Aventis Investigational Site Number 276002
Gauting, Germany, 82131
Sanofi-Aventis Investigational Site Number 276001
Großhansdorf, Germany, 22927
Italy
Sanofi-Aventis Investigational Site Number 380003
Livorno, Italy, 57123
Sanofi-Aventis Investigational Site Number 380001
Orbassano, Italy, 10043
Sanofi-Aventis Investigational Site Number 380002
Rozzano, Italy, 20089
Spain
Sanofi-Aventis Investigational Site Number 724001
Badalona, Spain, 08916
Sanofi-Aventis Investigational Site Number 724002
Barcelona, Spain, 08035
United Kingdom
Sanofi-Aventis Investigational Site Number 826001
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sanofi-Aventis Investigational Site Number 826002
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01086254    
Other Study ID Numbers: TCD11420
2009-017270-21 ( EudraCT Number )
U1111-1116-5404 ( Other Identifier: UTN )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Iniparib
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors