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Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Malignant Solid Tumors

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Trial Information

Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

The duration of the study for one patient in the dose escalation phase of the study will
include a screening period of up to 3 weeks and a 4-week treatment cycle(s). The patients
may continue treatment until disease progression, unacceptable toxicity, or willingness to
stop, followed by a minimum of 30-day follow-up. The study will also include 2 expansion
cohorts. If a patient treated in dose escalation part or in an expansion cohorts, 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.

Inclusion Criteria

Inclusion criteria:

- In the dose escalation part: patients with High MET tumor expression, evaluable or
measurable solid tumors for which no standard therapy is available.

- In the expansion cohorts: in the first cohort, patients with diagnosed MET- gene
amplified and measurable tumors will be eligible. In the second cohort, patients with
P-MET positive measurable solid tumor without MET-gene amplification will be

Exclusion criteria:

- Patient less than 18 years old.

- ECOG performance status >2.

- Any serious active disease or co-morbid condition, which, in the opinion of the
investigator, may interfere with the safety or the compliance with the study.

- Poor bone marrow reserve as defined by absolute neutrophils count <1.5 x 109/L or
platelets <100 x 109/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

- Serum creatinine >1.5 x ULN or

- Serum creatinine between 1.0 and 1.5 x UNL associated with calculated creatinine
clearance <60 mL/min

- Proteinuria > 500 mg/24H

- Pregnant or breast-feeding women.

- No use of effective birth control methods, when applicable.

- No measurable or evaluable tumor lesion in the Dose Escalation part, and no
measurable lesions in the expansion cohorts.

- 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 2 weeks from previous antitumor therapy or any
investigational treatment, (and less than 6 weeks in case of prior nitroso-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 or the interpretation of its results.

- Patients treated with potent CYP3A inhibitor.

- Patients treated with CYP3A inducers.

- Known hypersensitivity or any adverse event related to the study drug excipient.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844

Outcome Time Frame:

At day 28 of Cycle 1 of each treated patient, DLT is assessed

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



France: Committee for the Protection of Personnes

Study ID:




Start Date:

July 2011

Completion Date:

January 2016

Related Keywords:

  • Malignant Solid Tumors
  • Neoplasms