NCT02664103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

January 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

January 15, 2016

Last Update Submit

January 30, 2018

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients with adverse events

    12 weeks

  • Assessment of PK parameter: maximum concentration (Cmax)

    Daily 12 weeks

  • Assessment of PK parameter: time to reach Cmax (Tmax)

    Daily 12 weeks

Secondary Outcomes (4)

  • Disease Control Rate (DCR)

    12 weeks

  • Objective Response Rate (ORR)

    12 weeks

  • Time to Progression (TTP)

    12 weeks

  • Proportion of patients compliant with treatment

    12 weeks

Study Arms (3)

SAR439281(Cohort 1)

EXPERIMENTAL

Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption

Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

SAR439281(Cohort 2)

EXPERIMENTAL

Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption

Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

SAR439281(Cohort 3)

EXPERIMENTAL

Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption

Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281

Interventions

Fixed-dose combination of capecitabine and cyclophosphamide SAR439281DRUG

Pharmaceutical form:Tablet Route of administration: Oral

SAR439281(Cohort 1)SAR439281(Cohort 2)SAR439281(Cohort 3)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female ≥18 and ≤65 years old.
  • Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of the following characteristics:
  • Recurrence of the disease following at least 2 lines of chemotherapy failure for metastatic triple negative breast cancer.
  • In ER/PR positive breast cancer, recurrence of the disease following at least 1 line of chemotherapy failure and 2 lines of hormonal therapy failure.
  • Patients who have been previously treated with capecitabine can be recruited in the study provided:
  • As per the Investigator's opinion, patients will benefit from this chemotherapy AND
  • For prior single administration of capecitabine: at least 6 months has elapsed between last capecitabine treatment and initiation of study treatment.
  • For prior capecitabine-based combination regimen: at least 12 months has elapsed between last capecitabine-based treatment and initiation of study treatment.
  • At least one unidimensionally measurable lesion according to RECIST criteria version 1.1.
  • An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
  • Life expectancy of \>3 months.
  • Patients who are willing to undergo (oral) chemotherapy for the treatment of their disease and who are expected to comply with the treatment and study procedures, as per the Investigator's judgment.
  • For women of child bearing potential, documented negative pregnancy test and agreement to use acceptable birth control measures during the duration of the study.
  • Signed Informed consent obtained prior to any study related procedures.

You may not qualify if:

  • Patients who are HER 2 positive.
  • Patients with 3 or more lines of chemotherapy failure for metastatic triple negative breast cancer.
  • In ER/PR positive breast cancer, recurrence of the disease following 2 or more lines of chemotherapy failure and/or 3 or more lines of hormonal therapy failure.
  • Patients presenting with de novo stage IV metastatic breast cancer, not previously treated for their disease.
  • Patients who have already received any metronomic chemotherapy regimen.
  • Known hypersensitivity to capecitabine or to any of its components.
  • Known hypersensitivity to 5-fluorouracil.
  • Known hypersensitivity to cyclophosphamide or any of its components.
  • History of bladder carcinoma.
  • Systemic anticancer therapy (chemotherapy, hormone therapy, or radiotherapy) within 4 weeks of randomization for the study.
  • History of unexplained hematuria.
  • History of dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Severe renal impairment (creatinine clearance below 30 mL/min \[Cockroft and Gault\]).
  • Concomitant warfarin treatment.
  • History of significant cardiac disease (eg, unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) within the previous 6 months.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigational Site Number 356009

Kollkata, 700053, India

Location

Investigational Site Number 356002

Mumbai, 400012, India

Location

Investigational Site Number 356007

New Delhi, 110085, India

Location

Investigational Site Number 356008

Trivandrum, 695011, India

Location

Investigational Site Number 356001

Vellore, 632004, India

Location

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 26, 2016

Study Start

January 23, 2016

Primary Completion

November 6, 2017

Study Completion

November 6, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

IN(5)