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AzTrials

Malignant Solid TumorsPhase 1SARMETNCT01391533

Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing SAR125844 in people with Malignant Solid Tumors, run by Sanofi at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD. To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumors
What is being tested?
SAR125844
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
8 sitesin 4 countries
Study dates
Jul 2011to Apr 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 including NSCLC patients and measurable tumors for which no standard therapy is available will be eligible. In the second cohort, patients with advanced P-MET positive measurable solid tumor without MET- gene amplification for which no standard therapy is available will be eligible.

Who cannot join

  • 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 neutrophil 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. Alkaline phosphatase up to 5 x ULN in case of osteolytic bone metastasis without liver metastases is allowed
  • Serum creatinine >1.5 x ULN or
Show all 18Show fewer
  • Serum creatinine between 1.0 and 1.5 x ULN 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 3 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 unless it can be discontinued at least 2 weeks prior to study treatment or 5 elimination half-life, whichever is the longest.
  • Patients treated with potent and moderate CYP3A inducers unless it can be discontinued at least 2 weeks prior to study treatment or 5 elimination half-life, whichever is the longest. Patients treated with weak CYP3A inducers such as dexamethasone are eligible.
  • Known hypersensitivity or any adverse event related to the study drug excipient.
  • Prior treatment with any compound in the same class. Mean QTc interval prolongation.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Italy3 sites

  • Investigational Site Number 380004

    Bologna, 40138

  • Investigational Site Number 380002

    Milan, 20133

  • Investigational Site Number 380001

    Milan, 20141

Other trials in Italy

France2 sites

  • Investigational Site Number 250002

    Dijon, 21079

  • Investigational Site Number 250001

    Villejuif, 94805

Other trials in France

Spain2 sites

  • Investigational Site Number 724001

    Barcelona, 08035

  • Investigational Site Number 724003

    Madrid, 28040

Other trials in Spain

United States1 site

  • Investigational Site Number 840001

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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

Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD.

Read more

To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene amplification.

Secondary Objectives:

To characterize the global safety profile including cumulative toxicities. To evaluate the pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).

To assess preliminary antitumor activity in patients with measurable/evaluable disease, according to RECIST 1.1 criteria.

To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study, in the escalation part only.

To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit from SAR125844.

To explore MET-gene amplification status in circulating DNA.

Read the detailed description

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.

Being tested
SAR125844

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR125844Drug

    Pharmaceutical form:solution

    Route of administration: intravenous

Study groups in NCT01391533
Study groupRoleWhat they receive
Dose EscalationExperimentalDose escalation phase: The starting dose of SAR125844 will be 50 mg/m^2 up to 960 mg/m^2
Receives: Drug: SAR125844

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Expansion Cohorts To evaluate the preliminary anti-tumoral effect of SAR125844

    Measured: Anticancer activity is assessed at Day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years

Secondary outcomes (6)

  1. Number of patients with treatment emergent events

    Measured: Up to 2 years

  2. Assessment of PK parameter Cmax

    Measured: Up to 2 years

  3. Assessment of PK parameter AUCs

    Measured: Up to 2 years

  4. Assessment of PK parameter CL

    Measured: Up to 2 years

  5. Assessment of PD parameter ShedMET

    Measured: Up to 2 years

  6. Assessment of PD parameter HGF

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01391533
Sponsor's protocol ID
TED11449
Other IDs
2010-021398-36, U1111-1117-9878
Acronym
SARMET
Status last verified
Apr 2016
First submitted
6 Jul 2011
Last updated
13 Apr 2016
Results posted
No

Publications

  • Angevin E, Spitaleri G, Rodon J, Dotti K, Isambert N, Salvagni S, Moreno V, Assadourian S, Gomez C, Harnois M, Hollebecque A, Azaro A, Hervieu A, Rihawi K, De Marinis F. A first-in-human phase I study of SAR125844, a selective MET tyrosine kinase inhibitor, in patients with advanced solid tumours with MET amplification. Eur J Cancer. 2017 Dec;87:131-139. doi: 10.1016/j.ejca.2017.10.016. Epub 2017 Nov 14.

    PubMed 29145039

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR125844 in people with Malignant Solid Tumors, run by Sanofi at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy, France, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01391533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.

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