Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients

NCT01657214 | Completed Phase 1

• 2 other identifiers: TED12337U1111-1126-7527
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 8

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.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

• - 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 Outcomes (6)

• Number of patients with treatment emergent events

  Up to a maximum of 2 years

• Assessment of PK parameter Cmax

  Up to a maximum of 2 years

• Assessment of PK parameter AUCs

  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

Study Arms (1)

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.

Drug: SAR125844

Interventions

SAR125844 DRUG

Pharmaceutical form:Concentrate for solution Route of administration: intravenous

Dose escalation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Investigational Site Number 392001

Kashiwa-Shi, Japan

Location

Investigational Site Number 392004

Suita-Shi, Japan

Location

Investigational Site Number 392002

Sunto-Gun, Japan

Location

Investigational Site Number 392003

Takatsuki-Shi, Japan

Location

Investigational Site Number 410001

Seoul, 110-744, South Korea

Location

Investigational Site Number 410004

Seoul, 120-752, South Korea

Location

Investigational Site Number 410003

Seoul, 135-710, South Korea

Location

Investigational Site Number 410002

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SAR125844

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 6, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

JP (4); KR (4)