Clinical Trials /

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

NCT01156870

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: TED10499
  • SECONDARY ID: U1111-1116-4129
  • NCT ID: NCT01156870

Conditions

  • Neoplasm Malignant

Interventions

DrugSynonymsArms
SAR566658SAR566658

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
SAR566658ExperimentalSAR566658 will be administered by intravenous (IV) infusion according to three different schedules
  • SAR566658

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
Time Frame:3 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Pharmacokinetic (PK) parameters
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Immunogenicity evaluation (anti-drug antibodies)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Antitumoral response
Time Frame:Up to treatment discontinuation
Safety Issue:
Description:
Measure:To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
Time Frame:Up to Cycle 2
Safety Issue:
Description:
Measure:To assess safety in the alternative schedules of SAR566658 administration
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Sanofi

Last Updated

May 10, 2017