Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:September 20, 2017
End Date:January 8, 2021
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer

Primary Objectives:

Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with
palbociclib)

- To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859
based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in
combination with palbociclib (Part C)

Dose Expansion: Part B (SAR439859 monotherapy); Part D (combination SAR439859 with
palbociclib)

- To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859
recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D)

Secondary Objectives:

- Overall safety profile of SAR439859 as monotherapy (Parts A, B), and in combination with
palbociclib (Parts C, D)

- Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B), and of SAR439859
in combination with palbociclib (Parts C, D), and of palbociclib in combination with
SAR439859 (Parts C, D)

- Antitumor activity of SAR439859 as monotherapy (Part A), and in combination with
palbociclib (Part C) as well as the Clinical Benefit Rate (CBR: Complete Response [CR],
Partial Response [PR] and Stable Disease [SD] ≥24 weeks) in Parts A, B, C, and D

- ORR and CBR (CR, PR and SD ≥24 weeks) according to the estrogen receptor 1 (ESR1) gene
mutational status (mutant and wild type) at baseline and in treatment

- Time to first tumor response (CR or PR) in Parts B and D

- Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron
Emission Tomography (FES PET) scan (Part A)

Duration of the study, per patient, will include eligibility period (screening period) of up
to 4 weeks (28 days), treatment period (at least 1 cycle [28 days] of study treatment), and
end of treatment (EOT) visit after the last study treatment administration (i.e. at least 30
days post last treatment or until the patient receives another anticancer therapy, whichever
is earlier). The expected enrollment period is approximately 26 months.

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 human epidermal growth factor receptor 2 (HER2-) by
immunohistochemistry (IHC)

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 human immunodeficiency virus (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 that are metabolized by CYP3A

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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