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

NCT02664103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-02-01

No results posted yet for this study

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.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

Pharmaceutical form:Tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-23
Primary Completion
2017-11-06
Completion
2017-11-06

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664103 on ClinicalTrials.gov