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

Completed · Phase 1

Conditions studied: Neoplasm Malignant

In brief

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

Key facts

Study ID

NCT01156870

Run by

Sanofi

People needed

114

Starts

2010-09-08

Expected to finish

2017-04-07

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available.

You may not qualify if…

• Eastem Cooperative Oncology Group performance status ≥2.
• Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study.
• Poor bone marrow reserve.
• Poor liver and renal function.
• Pregnant or breast-feeding woman.
• No use of effective birth control methods, when applicable.
• No resolution of all specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to Grade ≤1 according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade scaling.
• Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment, (and less than 6 weeks in case of prior nitroso-urea and or mitomycin C treatment). Patients will be eligible if hormonotherapy (ie, for breast tumors) is discontinued before first Investigational product administration.
• Wash out period of less than 1 week from last palliative dose of radiotherapy.
• Patients with respiratory insufficiency defined by a decrease more than 50% compared to theoretical baseline pulmonary volumes and theoretical baseline Diffusing capacity of the Lung for Carbon monoxyde.
• Any lung radiotherapy in patient's cancer history.
• Patients with previous history or active interstitial lung disease or pulmonary fibrosis.
• Patients with abnormal cardiac function defined by a Left Ventricular Ejection Fraction <50%.
• Patients with previous history of acute cardiac failure.
• Patients with previous history and/or unresolved corneal disorders.
• Known intolerance to infused protein products or maytansinoids.
• Patients treated with strong CYP3A inhibitors within 2 weeks prior study drug administration.
• For patients to be treated in the midazolam cohort:
• Any treatment known to induce CYP3A isoenzymes or to inhibit CYP3A4 activities not allowed within 2 weeks before midazolam administration and up to the end of pharmacokinetic sampling following the last midazolam administration.
• Any contra-indications to midazolam, according to the applicable labeling.
• Patients older than 60 years.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840002 — Cincinnati, Ohio, United States
• Investigational Site Number 840001 — San Antonio, Texas, United States
• Investigational Site Number 250001 — Toulouse, France
• Investigational Site Number 724002 — Madrid, Spain
• Investigational Site Number 724001 — Madrid, Spain

Full record on ClinicalTrials.gov

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