Neoplasm MalignantPhase 1SARMETANCT01657214
Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
A Phase 1 study testing SAR125844 in people with Neoplasm Malignant, run by Sanofi at 8 sites in 2 countries.
Trial summary
Primary Objective: In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844. In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients). Read more about this study
- Who is it for?
- Ages 20 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
- 70 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 2012to Jan 2016
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with solid tumor for which no standard therapy is available.
- At the recommended dose (expansion cohort): only patients with measurable disease and MET gene amplification.
Who cannot join
- Patient less than 20 years old.
- ECOG performance status >2.
- Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 10^9/L or platelets <100 x 10^9/L.
- Poor organ function as defined by one of the following:
- Total bilirubin >1.5 x ULN.
- AST, ALT, alkaline phosphatase >2.5 x ULN or >5 x ULN in case of documented liver metastasis.
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- Serum creatinine >1.5 x ULN, or serum creatinine between 1.0 and 1.5 x ULN associated with calculated creatinine clearance <60 mL/min.
- Proteinuria >500mg/24h.
- Pregnant or breast-feeding women.
- Sexually active (males and females) who do not agree to use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug.
- Female patients of childbearing potential must have a negative pregnancy test at screening.
- Known or symptomatic brain metastasis (other than totally resected or previously pre-irradiated and no progressive/relapsing) or lepto-meningeal carcinomatosis.
- No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the NCI CTCAE v.4.03.
- Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment,(and less than 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment).
- Any surgery with major risk of bleeding performed less than 10 days prior to study treatment administration.
- Any other severe underlying medical conditions, which could impair the ability to participate in the study.
- Patients treated with potent CYP3A inhibitor.
- Patients treated with potent and moderate CYP3A inducers.
- Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
- Prior treatment with any MET inhibitor compound (selective or not).
- 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
8 sites in 2 countries.
8 sites in 2 countries
Japan4 sites
Investigational Site Number 392001
Kashiwa-Shi
Investigational Site Number 392004
Suita-Shi
Investigational Site Number 392002
Sunto-Gun
Investigational Site Number 392003
Takatsuki-Shi
South Korea4 sites
Investigational Site Number 410001
Seoul, 110-744
Investigational Site Number 410004
Seoul, 120-752
Investigational Site Number 410003
Seoul, 135-710
Investigational Site Number 410002
Seoul, 138-736
About this study
Official title: Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmacodynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
Primary Objective:
In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.
In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients).
Secondary Objectives:
To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities.
To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects.
To evaluate other pharmacodynamic biomarkers.
Read the detailed description
For both cohorts, escalation and expansion, the duration of the study for one patient will include a period for inclusion of up to 3 weeks and a 4-week treatment cycle(s).The patient may continue treatment until disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of 30-days follow-up.
If a patient treated in dose escalation part or in an expansion cohort, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment for a maximum of 1 year and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
- 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 |
|---|---|---|
| Dose escalation | Experimental | SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m^2), if the highest cleared dose in TED11449 is >340 mg/m^2. Receives: Drug: SAR125844 |
What is being measured
The primary outcome is the main question the study is designed to answer.
- DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
Measured: At d28 of Cycle 1 of each treated patient, DLT is assessed
- EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844
Measured: Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
Secondary outcomes (6)
Number of patients with treatment emergent events
Measured: Up to a maximum of 2 years
Assessment of PK parameter Cmax
Measured: Up to a maximum of 2 years
Assessment of PK parameter AUCs
Measured: Up to a maximum of 2 years
Assessment of PK parameter CL
Measured: Up to a maximum of 2 years
Assessment of PD parameter ShedMET
Measured: Up to a maximum of 2 years
Assessment of PD parameter HGF
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 posted6 Aug 2012 (estimated)
- Study startSep 2012
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT01657214
- Sponsor's protocol ID
- TED12337
- Other IDs
- U1111-1126-7527
- Acronym
- SARMETA
- Status last verified
- Feb 2016
- First submitted
- 24 Jul 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmacodynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT01657214
- Acronym / sponsor ID
- SARMETA / TED12337
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Aug 2012 (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:
In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.
In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients).
Secondary Objectives:
To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities.
To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects.
To evaluate other pharmacodynamic biomarkers.
Detailed description
For both cohorts, escalation and expansion, the duration of the study for one patient will include a period for inclusion of up to 3 weeks and a 4-week treatment cycle(s).The patient may continue treatment until disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of 30-days follow-up.
If a patient treated in dose escalation part or in an expansion cohort, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment for a maximum of 1 year and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: SAR125844SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m^2), if the highest cleared dose in TED11449 is >340 mg/m^2. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with solid tumor for which no standard therapy is available.
- At the recommended dose (expansion cohort): only patients with measurable disease and MET gene amplification.
Key exclusion criteria (21 listed)
- Patient less than 20 years old.
- ECOG performance status >2.
- Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 10^9/L or platelets <100 x 10^9/L.
- Poor organ function as defined by one of the following:
- Total bilirubin >1.5 x ULN.
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 | Dose escalation |
Primary outcome
- DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
Time frame: At d28 of Cycle 1 of each treated patient, DLT is assessed
- EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844
Time frame: Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
6 secondary outcomes
Number of patients with treatment emergent events
Time frame: Up to a maximum of 2 years
Assessment of PK parameter Cmax
Time frame: Up to a maximum of 2 years
Assessment of PK parameter AUCs
Time frame: Up to a maximum of 2 years
Assessment of PK parameter CL
Time frame: Up to a maximum of 2 years
Assessment of PD parameter ShedMET
Time frame: Up to a maximum of 2 years
Assessment of PD parameter HGF
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 17 Feb 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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR125844 in people with Neoplasm Malignant, run by Sanofi at 8 sites in 2 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 2 inclusion and 21 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan, South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
- DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844 (time frame: At d28 of Cycle 1 of each treated patient, DLT is assessed). The study lists 2 primary outcomes in all. 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 17 Feb 2016.