Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02754011
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2016-02-19
Brief Title:
Phase I Evaluating the Combination of RibociclibCapecitabine in Locally AdvancedMetastatic Breast Cancer HER2 Negative
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Dose-escalation Phase I Multicentric Trial Evaluating the Combination of Ribociclib and Capecitabine in Locally Advanced or Metastatic Breast Cancer HER2 Negative in Patients Previously Treated With Anthracyclines and Taxanes
Status:
COMPLETED
Status Verified Date:
2023-12
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:
GEP14-LEECAP
Brief Summary:
The proposed study is a multicenter open-label phase I trial conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts
STEP 1 a dose escalation part n up to 30 to evaluate the safety profile and pharmacokinetics and to define the MTD and RP2D to recommend in a phase II
STEP 2 an expansion cohort part to confirm the safety and tolerability of ribociclib and capecitabine association on a longer follow-up and to obtain preliminary evidence of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients Up to 14 patients in each cohort taking into account patients already included in step one at this DL may be enrolled for a total of 28 at the RP2D
STEP 1 a dose escalation part n up to 30 to evaluate the safety profile and pharmacokinetics and to define the MTD and RP2D to recommend in a phase II
STEP 2 an expansion cohort part to confirm the safety and tolerability of ribociclib and capecitabine association on a longer follow-up and to obtain preliminary evidence of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients Up to 14 patients in each cohort taking into account patients already included in step one at this DL may be enrolled for a total of 28 at the RP2D
Detailed Description:
Patients with HER2 negative locally advanced or metastatic breast cancer eligible to a capecitabine treatment as required by its approved indication ie previously treated with anthracyclines and taxanes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None