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

NCT01086254 | Completed Phase 2

• 3 other identifiers: TCD114202009-017270-21U1111-1116-5404
• Study Type: interventional
• Target: 119
• Locations: 5 countries
• Sites: 14

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.)

Conditions

Non-small Cell Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate

  up to a maximum follow-up of 25 weeks

Secondary Outcomes (2)

• progression free survival

  up to a maximum of 2 years

• overall survival

  up to a maximum of 2 years

Study Arms (2)

Iniparib/ Gemcitabine/ Cisplatin

EXPERIMENTAL

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; Drug: gemcitabine; Drug: cisplatin

Gemcitabine/ Cisplatin

ACTIVE COMPARATOR

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; Drug: cisplatin

Interventions

Iniparib DRUG

Pharmaceutical form: solution for infusion Route of administration: 60-minute IV infusion

Also known as: SAR240550, BSI-201

Iniparib/ Gemcitabine/ Cisplatin

gemcitabine DRUG

Pharmaceutical form: solution for infusion Route of administration: 30-minute IV infusion

Gemcitabine/ Cisplatin; Iniparib/ Gemcitabine/ Cisplatin

cisplatin DRUG

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

Gemcitabine/ Cisplatin; Iniparib/ Gemcitabine/ Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (14)

Sanofi-Aventis Investigational Site Number 250002

Caen, 14033, France

Location

Sanofi-Aventis Investigational Site Number 250003

Marseille, 13009, France

Location

Sanofi-Aventis Investigational Site Number 250004

Toulouse, 31059, France

Location

Sanofi-Aventis Investigational Site Number 250001

Villejuif, 94805, France

Location

Sanofi-Aventis Investigational Site Number 276003

Essen, 45122, Germany

Location

Sanofi-Aventis Investigational Site Number 276002

Gauting, 82131, Germany

Location

Sanofi-Aventis Investigational Site Number 276001

Großhansdorf, 22927, Germany

Location

Sanofi-Aventis Investigational Site Number 380003

Livorno, 57123, Italy

Location

Sanofi-Aventis Investigational Site Number 380001

Orbassano, 10043, Italy

Location

Sanofi-Aventis Investigational Site Number 380002

Rozzano, 20089, Italy

Location

Sanofi-Aventis Investigational Site Number 724001

Badalona, 08916, Spain

Location

Sanofi-Aventis Investigational Site Number 724002

Barcelona, 08035, Spain

Location

Sanofi-Aventis Investigational Site Number 826001

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Sanofi-Aventis Investigational Site Number 826002

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• Novello S, Besse B, Felip E, Barlesi F, Mazieres J, Zalcman G, von Pawel J, Reck M, Cappuzzo F, Ferry D, Carcereny E, Santoro A, Garcia-Ribas I, Scagliotti G, Soria JC. A phase II randomized study evaluating the addition of iniparib to gemcitabine plus cisplatin as first-line therapy for metastatic non-small-cell lung cancer. Ann Oncol. 2014 Nov;25(11):2156-2162. doi: 10.1093/annonc/mdu384. Epub 2014 Aug 19.

  PMID: 25139550 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

iniparib; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

IT (3); ES (2); DE (3); GB (2); FR (4)