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

• Register: EUCTR
• Last refreshed on: 27 May 2013
• Main ID: EUCTR2009-017270-21-DE
• Date of registration: 05/03/2010
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public 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
• Scientific 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
• Date of first enrolment: 09/06/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017270-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion 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. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during 6 months after the last study treatment administration.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 =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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-small cell lung cancer stage IV.
MedDRA version: 12.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV

Intervention(s)

Product Code: SAR240550 (BSI-201)
Pharmaceutical Form: Solution for infusion
Current Sponsor code: SAR240550 (BSI-201)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate.

Main Objective: Primary objective is to assess the objective response rate (ORR) of 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 gemcitabin/cisplatin (GC) in patients with stage IV non small cell lung cancer.

Secondary Objective: - To assess the safety profiles of the study combination gemcitabine/cisplatin/SAR240550 (GCS) and of the standard regimen gemcitabine/cisplatin (GC) alone
- 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 SAR240550 on PAR level in peripheral blood mononuclear cells (PBMC).

Secondary ID(s)

TCD11420

2009-017270-21-FR