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

NCT ID: NCT01657214

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SAR125844

Intervention Type: DRUG

Pharmaceutical form:Concentrate for solution

Route of administration: intravenous

Interventions

SAR125844

Pharmaceutical form:Concentrate for solution

Route of administration: intravenous

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392001

Kashiwa-Shi, , Japan

Investigational Site Number 392004

Suita-Shi, , Japan

Investigational Site Number 392002

Sunto-Gun, , Japan

Investigational Site Number 392003

Takatsuki-Shi, , Japan

Investigational Site Number 410001

Seoul, , South Korea

Investigational Site Number 410004

Seoul, , South Korea

Investigational Site Number 410003

Seoul, , South Korea

Investigational Site Number 410002

Seoul, , South Korea

Countries

Japan; South Korea

Other Identifiers

U1111-1126-7527

Identifier Type: OTHER

Identifier Source: secondary_id

TED12337

Identifier Type: -

Identifier Source: org_study_id