Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05223673
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2022-01-25
Brief Title:
Phase 3 Study of FutuximabModotuximab in Combination With TrifluridineTipiracil Versus TrifluridineTipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Sponsor:
Institut de Recherches Internationales Servier
Organization:
Servier
Study Overview
Official Title:
A Randomised Open-label Multi-centre Two-arm Phase 3 Study Comparing FutuximabModotuximab in Combination With TrifluridineTipiracil to TrifluridineTipiracil Single Agent With a Safety Lead-In Part in Participants With KRASNRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to discontinue the study during the Lead-In part and the Phase III part was not started due to strategic reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLSTAR
Brief Summary:
This is a randomized phase III study with a safety lead-in part in patients with KRAS NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin irinotecan fluoropyrimidines anti-VEGF agents and anti-EGFR antibodies The main objective of the safety lead-in part is to assess safety and tolerability of futuximabmodotuximab in combination with trifluridinetipiracil The primary objective of the phase III part is to compare Overall Survival of futuximabmodotuximab in combination with trifluridinetipiracil vs trifluridinetipiracil monotherapy in patients with tumours that are KRASNRAS and BRAF wild-type WT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003151-41 | EUDRACT_NUMBER | None | None |