Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer Metastatic
• Interventions: Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

• Registration Number: NCT02664103
• Lead Sponsor: Sanofi

Brief Summary

Primary Objectives:

* To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer.

* To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer.

Secondary Objectives:

* To assess antitumor activity of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer given at 3 different doses and schedules (regimen 1=standard dose twice daily \[BID\], regimen 2=full dose once daily \[OD\], regimen 3=low dose \[OD\])

* Disease Control Rate (DCR)

* Overall Response Rate (ORR)

* Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).

* To evaluate the compliance under treatment.

* To describe evolution of toxicities.

* To assess safety all along patient's treatment.

Detailed Description

Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will be treated and followed-up until progression of the disease.

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-21
• Study Start: 2016-01-23
• Study First Posted: 2016-01-26
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR439281(Cohort 2)	Fixed-dose combination of capecitabine and cyclophosphamide SAR439281	Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption
SAR439281(Cohort 1)	Fixed-dose combination of capecitabine and cyclophosphamide SAR439281	Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption
SAR439281(Cohort 3)	Fixed-dose combination of capecitabine and cyclophosphamide SAR439281	Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption

Primary Outcome Measures

Name	Time	Method
Assessment of PK parameter: time to reach Cmax (Tmax)	Daily 12 weeks
Proportion of patients with adverse events	12 weeks
Assessment of PK parameter: maximum concentration (Cmax)	Daily 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	12 weeks
Disease Control Rate (DCR)	12 weeks
Objective Response Rate (ORR)	12 weeks
Proportion of patients compliant with treatment	12 weeks

Trial Locations

Locations (5)

Investigational Site Number 356001; 🇮🇳 Vellore, India

Investigational Site Number 356009; 🇮🇳 Kollkata, India

Investigational Site Number 356002; 🇮🇳 Mumbai, India

Investigational Site Number 356007; 🇮🇳 New Delhi, India

Investigational Site Number 356008; 🇮🇳 Trivandrum, India