Neoplasm MalignantPhase 2NCT02435121
A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
A Phase 2 study testing SAR125844 in people with Neoplasm Malignant, run by Sanofi at 1 site in Belgium.
Trial summary
Primary Objective: To determine objective response rate (ORR). Secondary Objectives: To assess duration of response (DR), progression free survival (PFS) and overall survival (OS). To evaluate global safety profile. To determine pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR125844
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2015to Jan 2016
- 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
- Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Who cannot join
- Patient less than 18 years old. Eastern Cooperative Oncology Group (ECOG) performance status >2. More than 2 episodes of disease progression under anticancer therapy. Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment.
- Adequate hematologic, hepatic, renal, coagulation, and metabolic functions. No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
- Pregnant or breast-feeding women. Patient with reproductive potential without method of contraception. Symptomatic brain metastasis. Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity.
- Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
- Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab).
- Patients treated with potent CYP3A inhibitor unless it can be discontinued. Patients treated with potent and moderate CYP3A inducers unless it can be discontinued.
- Mean QTc interval prolongation >470 msec.
- 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
1 site in 1 country.
About this study
Official title: Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients With Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification
Primary Objective:
To determine objective response rate (ORR).
Secondary Objectives:
To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).
To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplification.
To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.
Read the detailed description
The duration of the study for 1 patient will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a follow-up period. The patients will be treated for 6 cycles in case no response is observed, and treatment may be continued beyond 6 cycles in case of partial response/complete response (PR/CR) or significant clinical benefit until progressive disease, unacceptable toxicity, willingness to stop the study treatment or until study termination by sponsor. After the completion of the study treatment each patient will be followed every 6 weeks until death or the study cut-off date, whichever comes first. For patients who went-off study treatment prior disease progression is documented, date of disease progression and further anticancer treatment will be collected in follow-up visit.
The cut-off date corresponds to the date at which all the treated patients will have 3 post-baseline tumor assessments or will early discontinue whatever the reason. Beyond cut-off date, patient can continue study treatment until disease progression, unacceptable toxicity or patient's refusal, provided clinical benefit is established.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR125844
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR125844Drug
Pharmaceutical form:Concentrate for solution Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR125844 | Experimental | Given intravenously weekly at the dose of 570 mg/m^2 for at least 18 weeks Receives: Drug: SAR125844 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the objective response rate of SAR125844 as per RECIST 1.1
Measured: every 6 weeks up to 34 months
Secondary outcomes (10)
Progression-free survival rate
Measured: up to 34 months
Overall survival rate
Measured: up to 34 months
Proportion of patients with adverse events
Measured: up to 40 months
Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
Measured: up to 3 days
Assessment of pharmacokinetic parameters: area under curve (AUC)
Measured: up to 3 days
Assessment of pharmacokinetic parameters: total clearance (CL)
Measured: up to 3 days
Assessment of pharmacokinetic parameters: half-life (t1/2)
Measured: up to 3 days
Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
Measured: every 3 weeks up to 34 months
Assessment of health-related quality of life by QLQ-C30/LC13
Measured: every 3 weeks up to 34 months
Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire
Measured: every 6 weeks up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT02435121
- Sponsor's protocol ID
- ACT14205
- Other IDs
- 2014-005696-93, U1111-1163-1136, 2014
- Status last verified
- Feb 2016
- First submitted
- 27 Apr 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients With Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification
- ClinicalTrials.gov ID
- NCT02435121
- Acronym / sponsor ID
- ACT14205
- Conditions
- Neoplasm Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 2015 (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 determine objective response rate (ORR).
Secondary Objectives:
To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).
To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplification.
To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.
Detailed description
The duration of the study for 1 patient will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a follow-up period. The patients will be treated for 6 cycles in case no response is observed, and treatment may be continued beyond 6 cycles in case of partial response/complete response (PR/CR) or significant clinical benefit until progressive disease, unacceptable toxicity, willingness to stop the study treatment or until study termination by sponsor. After the completion of the study treatment each patient will be followed every 6 weeks until death or the study cut-off date, whichever comes first. For patients who went-off study treatment prior disease progression is documented, date of disease progression and further anticancer treatment will be collected in follow-up visit.
The cut-off date corresponds to the date at which all the treated patients will have 3 post-baseline tumor assessments or will early discontinue whatever the reason. Beyond cut-off date, patient can continue study treatment until disease progression, unacceptable toxicity or patient's refusal, provided clinical benefit is established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR125844 | Experimental | Drug: SAR125844Given intravenously weekly at the dose of 570 mg/m^2 for at least 18 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Key exclusion criteria (8 listed)
- Patient less than 18 years old. Eastern Cooperative Oncology Group (ECOG) performance status >2. More than 2 episodes of disease progression under anticancer therapy. Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment.
- Adequate hematologic, hepatic, renal, coagulation, and metabolic functions. No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
- Pregnant or breast-feeding women. Patient with reproductive potential without method of contraception. Symptomatic brain metastasis. Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity.
- Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
- Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab).
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 |
|---|---|---|
| SAR125844Pharmaceutical form:Concentrate for solution Route of administration: intravenous | Drug | SAR125844 |
Primary outcome
Determination of the objective response rate of SAR125844 as per RECIST 1.1
Time frame: every 6 weeks up to 34 months
10 secondary outcomes
Progression-free survival rate
Time frame: up to 34 months
Overall survival rate
Time frame: up to 34 months
Proportion of patients with adverse events
Time frame: up to 40 months
Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
Time frame: up to 3 days
Assessment of pharmacokinetic parameters: area under curve (AUC)
Time frame: up to 3 days
Assessment of pharmacokinetic parameters: total clearance (CL)
Time frame: up to 3 days
Assessment of pharmacokinetic parameters: half-life (t1/2)
Time frame: up to 3 days
Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
Time frame: every 3 weeks up to 34 months
Assessment of health-related quality of life by QLQ-C30/LC13
Time frame: every 3 weeks up to 34 months
Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire
Time frame: every 6 weeks up to 34 months
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 23 Mar 2016.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR125844 in people with Neoplasm Malignant, run by Sanofi at 1 site in Belgium.
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 1 inclusion and 8 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Determination of the objective response rate of SAR125844 as per RECIST 1.1 (time frame: every 6 weeks up to 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2016.