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A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasm Malignant

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Trial Information

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer


Total duration of study participation for each patient will be one month screening + 6
months from the first dose.

Inclusion Criteria


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; For MTD cohort expansion, 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 pregnancy test.

- Pregnancy or breast-feeding.

- Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas)
or 5 half-lives 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.

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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

SAR405838 Maximum tolerated dose (MTD)

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

TED12318

NCT ID:

NCT01636479

Start Date:

July 2012

Completion Date:

February 2015

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms

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