Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients (SARMETA)
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.
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 anti-tumor effects.
To evaluate other pharmacodynamic biomarkers.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmaco-Dynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors|
- Dose escalation to determine the maximum tolerated dose (MTD) of SAR125844 [ Time Frame: At day 28 of Cycle 1 of each treated patient, DLT is assessed ] [ Designated as safety issue: Yes ]
- Expansion cohort to evaluate the preliminary anti-tumoral effect of SAR125844 [ Time Frame: Anticancer activity is assessed at day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years ] [ Designated as safety issue: No ]
- Number of patients with treatment emergent events [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: Yes ]
- Assessment of PK parameter Cmax [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
- Assessment of PK parameter AUCs [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
- Assessment of PK parameter CL [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
- Assessment of PD parameter ShedMET [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
- Assessment of PD parameter HGF [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Dose escalation
SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose is 260mg/m2.
Pharmaceutical form:Concentrate for solution
Route of administration: intravenous
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657214
|Contact: For site information, send an email with site number to||Contact-Us@sanofi.com|
|Investigational Site Number 392001||Recruiting|
|Investigational Site Number 392002||Recruiting|
|Korea, Republic of|
|Investigational Site Number 410001||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Investigational Site Number 410002||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||Clinical Sciences & Operations||Sanofi|