Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
- Registration Number
- NCT01657214
- Lead Sponsor
- Sanofi
- Brief 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).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation SAR125844 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.
- Primary Outcome Measures
Name Time Method - DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844 At d28 of Cycle 1 of each treated patient, DLT is assessed - EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844 Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter CL Up to a maximum of 2 years Assessment of PD parameter ShedMET Up to a maximum of 2 years Assessment of PK parameter Cmax Up to a maximum of 2 years Assessment of PD parameter HGF Up to a maximum of 2 years Number of patients with treatment emergent events Up to a maximum of 2 years Assessment of PK parameter AUCs Up to a maximum of 2 years
Trial Locations
- Locations (8)
Investigational Site Number 392001
🇯🇵Kashiwa-Shi, Japan
Investigational Site Number 392004
🇯🇵Suita-Shi, Japan
Investigational Site Number 392002
🇯🇵Sunto-Gun, Japan
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 392003
🇯🇵Takatsuki-Shi, Japan
Investigational Site Number 410004
🇰🇷Seoul, Korea, Republic of