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CompletedNCT01657214SARMETAUpdated Feb 17, 2016

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

A Phase 1 interventional study of SAR125844 in Neoplasm Malignant, sponsored by Sanofi. Completed at 8 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neoplasm Malignant

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    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.

    Drug: SAR125844

Interventions

  • DrugSAR125844

    Pharmaceutical form:Concentrate for solution Route of administration: intravenous

06

What researchers measure

Primary outcomes

  1. - 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

  2. - 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

  1. Number of patients with treatment emergent events

    Time frame: Up to a maximum of 2 years

  2. Assessment of PK parameter Cmax

    Time frame: Up to a maximum of 2 years

  3. Assessment of PK parameter AUCs

    Time frame: Up to a maximum of 2 years

  4. Assessment of PK parameter CL

    Time frame: Up to a maximum of 2 years

  5. Assessment of PD parameter ShedMET

    Time frame: Up to a maximum of 2 years

  6. Assessment of PD parameter HGF

    Time frame: Up to a maximum of 2 years

07

Study locations

8 sites
  • 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, 110-744, Korea, Republic of
  • Investigational Site Number 410004
    Seoul, 120-752, Korea, Republic of
  • Investigational Site Number 410003
    Seoul, 135-710, Korea, Republic of
  • Investigational Site Number 410002
    Seoul, 138-736, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01657214
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Aug 6, 2012
Start date
Sep 2012
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Feb 17, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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