Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmaco-Dynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
20 Years
N/A
Both
Neoplasm Malignant
Trial Information
Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmaco-Dynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
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.
Inclusion 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 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
metastasis
- 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 > 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 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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:
Yes
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Korea: Food and Drug Administration
Study ID:
TED12337
NCT ID:
NCT01657214
Start Date:
September 2012
Completion Date:
February 2016
Related Keywords:
- Neoplasm Malignant
- Neoplasms
Name | Location |
|---|
