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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01156870
• Date of registration: 02/07/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
• Scientific title: 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
• Date of first enrolment: September 8, 2010
• Target sample size: 114
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01156870
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Spain, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

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

Exclusion criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasm Malignant

Intervention(s)

Drug: SAR566658

Primary Outcome(s)

To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe [Time Frame: At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing]

Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658 [Time Frame: 3 weeks]

Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658 [Time Frame: Anticancer activity is assessed every 6 weeks]

Secondary Outcome(s)

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 [Time Frame: Up to 2 years]

Antitumoral response [Time Frame: Up to treatment discontinuation]

Immunogenicity evaluation (anti-drug antibodies) [Time Frame: Up to 2 years]

To assess safety in the alternative schedules of SAR566658 administration [Time Frame: Up to 2 years]

Pharmacokinetic (PK) parameters [Time Frame: Up to 2 years]

To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam [Time Frame: Up to Cycle 2]

Secondary ID(s)

U1111-1116-4129

TED10499

Source(s) of Monetary Support

Please refer to primary and secondary sponsors