Non-small Cell Lung Cancer Stage IVPhase 2NCT01086254
SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer
A Phase 2 study testing Iniparib, gemcitabine and cisplatin in people with Non-small Cell Lung Cancer Stage IV, run by Sanofi at 14 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IV
- What is being tested?
- Iniparib, gemcitabine and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 14 sitesin 5 countries
- Study dates
- May 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
France4 sites
Sanofi-Aventis Investigational Site Number 250002
Caen, 14033
Sanofi-Aventis Investigational Site Number 250003
Marseille, 13009
Sanofi-Aventis Investigational Site Number 250004
Toulouse, 31059
Sanofi-Aventis Investigational Site Number 250001
Villejuif, 94805
Germany3 sites
Sanofi-Aventis Investigational Site Number 276003
Essen, 45122
Sanofi-Aventis Investigational Site Number 276002
Gauting, 82131
Sanofi-Aventis Investigational Site Number 276001
Großhansdorf, 22927
Italy3 sites
Sanofi-Aventis Investigational Site Number 380003
Livorno, 57123
Sanofi-Aventis Investigational Site Number 380001
Orbassano, 10043
Sanofi-Aventis Investigational Site Number 380002
Rozzano, 20089
Spain2 sites
Sanofi-Aventis Investigational Site Number 724001
Badalona, 08916
Sanofi-Aventis Investigational Site Number 724002
Barcelona, 08035
United Kingdom2 sites
Sanofi-Aventis Investigational Site Number 826001
Newcastle upon Tyne, NE7 7DN
Sanofi-Aventis Investigational Site Number 826002
Wolverhampton, WV10 0QP
About this study
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
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.
Read more
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.)
Read the 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.
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Being tested
- Iniparib, gemcitabine, cisplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IniparibDrug
Also called SAR240550, BSI-201
Pharmaceutical form: solution for infusion
Route of administration: 60-minute IV infusion
gemcitabineDrug
Pharmaceutical form: solution for infusion
Route of administration: 30-minute IV infusion
cisplatinDrug
Pharmaceutical form: solution for infusion
Route of administration: 1- to 4-hour IV infusion, according to the local standard
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: gemcitabine; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate
Measured: up to a maximum follow-up of 25 weeks
Secondary outcomes (2)
progression free survival
Measured: up to a maximum of 2 years
overall survival
Measured: up to a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086254
- Sponsor's protocol ID
- TCD11420
- Other IDs
- 2009-017270-21, U1111-1116-5404, 2009
- Status last verified
- Sep 2013
- First submitted
- 11 Mar 2010
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25139550
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01086254
- Acronym / sponsor ID
- TCD11420
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iniparib/ Gemcitabine/ Cisplatin | Experimental | Drug: Iniparib, Drug: gemcitabine, Drug: cisplatinIniparib, 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. |
| Gemcitabine/ Cisplatin | Active comparator | Drug: gemcitabine, Drug: cisplatinGemcitabine, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IniparibAlso: SAR240550, BSI-201Pharmaceutical form: solution for infusion Route of administration: 60-minute IV infusion | Drug | Iniparib/ Gemcitabine/ Cisplatin |
| gemcitabinePharmaceutical form: solution for infusion Route of administration: 30-minute IV infusion | Drug | Gemcitabine/ Cisplatin, Iniparib/ Gemcitabine/ Cisplatin |
| cisplatinPharmaceutical form: solution for infusion Route of administration: 1- to 4-hour IV infusion, according to the local standard | Drug | Gemcitabine/ Cisplatin, Iniparib/ Gemcitabine/ Cisplatin |
Primary outcome
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
2 secondary outcomes
progression free survival
Time frame: up to a maximum of 2 years
overall survival
Time frame: up to a maximum of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Derived from this study: PubMed 25139550Novello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iniparib, gemcitabine and cisplatin in people with Non-small Cell Lung Cancer Stage IV, run by Sanofi at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Germany, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.