Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT02664103
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2016-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METRO-ABC
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1166-1149 | OTHER | UTN | View |