Phase 1 / 2 of SAR439859 single agent or in combination with palbociclib in postmenopausal women estrogen receptor positive advanced breast cancer

Phase 1

• Conditions: Cancer; MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000690-36-ES
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 195

Inclusion Criteria

Parts A, B, C and D
-Patients must be postmenopausal women
-Histological diagnosis of breast adenocarcinoma
-Locally advanced or metastatic disease
-Measurable disease
-Previously treated for advanced disease
-Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry ( IHC)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 97

Exclusion Criteria

-Medical history or ongoing gastrointestinal disorders that could affect absorption of SAR439859
and/or palbociclib ( including difficulties with swallowing capsules)
-Patient with any other cancer (except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer or any other cancer from which the patient has been disease free
for >3 years)
-Patients with known brain metastases and endometrial disorders
-Treatment with anticancer agents (including investigational drugs) less than 2 weeks before first
study treatment starts (less than 4 weeks if the anticancer agents were antibodies).
-Prior treatment with another selective ER down-regulator (SERD) (except fulvestrant).
-Inadequate hematological and biochemical lab tests
-Patients with Gilbert disease
-Treatment with HIV-antiviral, antifungal and antioxidant agents less than 2 weeks before study treatment starts
-Treatment with strong and moderate CYP3A inducers/inhibitors within 2 weeks before first study treatment
Part A only:
Patients with liver metastases only
Parts C and D only:
-Prior therapy with any selective cyclin-dependent kinase (CDK) 4/6 inhibitor
-Treatment with strong and moderate CYP3A inducers or strong CYP3A inhibitors within 2 weeks before
first study treatment starts
-Medical conditions requiring concomitant medications with that are metabolized by CYP3A

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified