Status:
COMPLETED
First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
Lead Sponsor:
Sanofi
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 SA...
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2017
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01156870
Start Date
September 8 2010
End Date
April 7 2017
Last Update
May 10 2017
Active Locations (5)
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1
Investigational Site Number 840002
Cincinnati, Ohio, United States, 45267-0542
2
Investigational Site Number 840001
San Antonio, Texas, United States, 78229
3
Investigational Site Number 250001
Toulouse, France, 31052
4
Investigational Site Number 724002
Madrid, Spain, 28040