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

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients with Advanced Cancer. - TED12318

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44662

Enrollment

Registered

2012-05-04

Start date

2012-07-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced cancer

Interventions

SAR405838 will be taken at various doses by mouth once daily.

Eligibility

Age

18 Years to 99 Years

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. 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

Exclusion criteria: * Age > 18 years. *Eastern Cooperative Oncology Group (ECOG)performance status of >1. *Life expectancy

Design outcomes

Primary

Measure	Time frame
* SAR405838 Maximum Tolerated Dose (MTD) * In MTD cohort, clinical benefit	—

Secondary

Measure	Time frame
* Adverse events (eg, number of patients experience adverse events) * PK parameters (Cmax, Tmax, AUC) * Biomarkers * Clinical Response * Drug administration compliance	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)