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
Overview
- Phase
- Phase 1
- Intervention
- SAR125844
- Conditions
- Neoplasm Malignant
- Sponsor
- Sanofi
- Enrollment
- 70
- Locations
- 8
- Primary Endpoint
- - DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: SAR125844
Outcomes
Primary Outcomes
- 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
Secondary Outcomes
- 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 CL(Up to a maximum of 2 years)
- Assessment of PD parameter ShedMET(Up to a maximum of 2 years)
- Assessment of PK parameter AUCs(Up to a maximum of 2 years)