NCT01156870

First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor

Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To determine the maximum tolerated dose (MTD) of SAR566658 Secondary Objectives: * To characterize the safety profile of SAR566658 * To evaluate the pharmacokinetic profile of SAR566658 * To assess the potential immunogenicity of SAR566658 * To assess preliminary antitumor activity * To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam * To assess safety in the alternative schedules of SAR566658 administration

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, a 3-week treatment cycle(s) and a 2-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. 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 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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR566658	Pharmaceutical form:solution for infusion Route of administration: intravenous

Timeline

• Start date: 2010-09-08
• Primary completion: 2017-04-07
• Completion: 2017-04-07
• First posted: 2010-07-05
• Last updated: 2017-05-10

Locations

5 sites across 3 countries: United States, France, Spain