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

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: SAR566658

• Registration Number: NCT01156870
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Study Start: 2010-09-08
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR566658	SAR566658	SAR566658 will be administered by intravenous (IV) infusion according to three different schedules

Primary Outcome Measures

Name	Time	Method
Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658	3 weeks
Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658	Anticancer activity is assessed every 6 weeks
To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe	At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing

Secondary Outcome Measures

Name	Time	Method
Overall safety profile based on adverse events reporting, laboratory tests, vital signs and specific pulmonary and ocular tests, according to the NCI-CTC AE v4.03	Up to 2 years
Pharmacokinetic (PK) parameters	Up to 2 years
Immunogenicity evaluation (anti-drug antibodies)	Up to 2 years
To assess safety in the alternative schedules of SAR566658 administration	Up to 2 years
Antitumoral response	Up to treatment discontinuation
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam	Up to Cycle 2

Trial Locations

Locations (5)

Investigational Site Number 840002; 🇺🇸 Cincinnati, Ohio, United States

Investigational Site Number 250001; 🇫🇷 Toulouse Cedex, France

Investigational Site Number 840001; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 724002; 🇪🇸 Madrid, Spain

Investigational Site Number 724001; 🇪🇸 Madrid, Spain