Primary objective* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).* To assess biological activities of SAR405838 in patients with dedifferentiated liposarcoma…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* SAR405838 Maximum Tolerated Dose (MTD)
* In MTD cohort, clinical benefit
Secondary outcome
* Adverse events (eg, number of patients experience adverse events)
* PK parameters (Cmax, Tmax, AUC)
* Biomarkers
* Clinical Response
* Drug administration compliance
Background summary
SAR405838 is a new anti-cancer study drug that may stop the growth of cancer by
causing cancer cell death or blocking cancer cell division.
SAR405838 has only shown its ability to slow or stop tumor growth when tested
in animal models. Its effects in humans are currently unknown. This research
study is the first use of SAR405838 in the treatment of patients.
Study objective
Primary objective
* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through
the characterization of dose-limiting toxicities (DLTs).* To assess biological
activities of SAR405838 in patients with dedifferentiated liposarcoma during
MTD cohort expansion.
secondory objective
* pharmacokinetic (PK) profile of SAR405838
* Biomarkers in association with SAR405838
* Anti- tumor activity in response to SAR405838
* Food effect on SAR405838 PK
* compliance with SAR405838 treatment
* Cytochrome P450 3A4/5 (CYP3A4/5) activity
Study design
This is a multicenter study being conducted in Europe.
Approximately 66 patients will take part in the study in dose finding phase and
16 expansion phase.
The study consists of 3 parts:
*screening,
* study treatment,
* follow-up visit.
The total duration of participation in the study will be approximately 16 to 30
weeks.
Intervention
SAR405838 will be taken at various doses by mouth once daily.
Study burden and risks
Risks are related to blood sampling and possible side effects of study drug.The
burden for the patient will be the number of visits to the center as part of
the trial.
Kampenringweg 45E
GOUDA 2803 PE
NL
Kampenringweg 45E
GOUDA 2803 PE
NL
Listed location countries
Age
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
* Patients with lymphomas may be enrolled.
* For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status. At a specified dose level, enrollment will be limited to dedifferenitated liposarcoma, and for the MTD cohort, only dedifferentiated liposarcoma will be included.
* Presence of locally advanced or metastatic disease with at least one measurable lesion.
Exclusion criteria
* Age > 18 years.
*Eastern Cooperative Oncology Group (ECOG)performance status of >1.
*Life expectancy <12 weeks.
*Unstable brain or leptomeningeal disease based on history and physical examination.
* Inadequate organ functions, positive pregancy test
* Pregnancy or breast-feeding.
*Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) prior to study treatment or 5 halflives of the drug prior to study treatment, whichever is shorter, prior to study treatment.;Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception;during the study drug administration and follow-up periods.;Recent (3 months) history of acute pancreatitis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000733-39-NL |
| ClinicalTrials.gov | NCT01636479 |
| CCMO | NL40400.031.12 |