- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657214
Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients (SARMETA)
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Kashiwa-Shi, Japan
- Investigational Site Number 392001
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Suita-Shi, Japan
- Investigational Site Number 392004
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Sunto-Gun, Japan
- Investigational Site Number 392002
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Takatsuki-Shi, Japan
- Investigational Site Number 392003
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Seoul, Korea, Republic of, 135-710
- Investigational Site Number 410003
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Seoul, Korea, Republic of, 138-736
- Investigational Site Number 410002
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Seoul, Korea, Republic of, 120-752
- Investigational Site Number 410004
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Seoul, Korea, Republic of, 110-744
- Investigational Site Number 410001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dose escalation
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.
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Pharmaceutical form:Concentrate for solution Route of administration: intravenous |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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- 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
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At d28 of Cycle 1 of each treated patient, DLT is assessed
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- 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
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Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of patients with treatment emergent events
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Assessment of PK parameter Cmax
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Assessment of PK parameter AUCs
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Assessment of PK parameter CL
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Assessment of PD parameter ShedMET
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Assessment of PD parameter HGF
Time Frame: Up to a maximum of 2 years
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Up to a maximum of 2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TED12337
- U1111-1126-7527 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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