Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614192
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously IV Infused ABBV-400 to Trifluridine and Tipiracil LONSURF Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Randomized Controlled Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF Trifluridine and Tipiracil Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer CRC is the third most common type of cancer diagnosed worldwide and in China The purpose of this study is to assess adverse events and disease activity when comparing intravenously IV infused ABBV-400 to trifluridine and tipiracil LONSURF oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer mCRC
ABBV-400 is an investigational drug being developed for the treatment of CRC Participants are put into treatment arms as part of 2 stages Each treatment arm in stage 1 receives a different dose of ABBV-400 Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab Up to approximately 460 adult participants with c-Met over-expressed OE refractory mCRC will be enrolled in the study in approximately 160 sites in 15-20 countries
In stage 1 participants will receive intravenously IV infused ABBV-400 dose A or B In stage 2 participants will receive the optimal dose of IV infused ABBV-400 or the standard of care SOC LONSURF oral tablets plus IV infused bevacizumab The total study duration will be approximately 4 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and side effects
ABBV-400 is an investigational drug being developed for the treatment of CRC Participants are put into treatment arms as part of 2 stages Each treatment arm in stage 1 receives a different dose of ABBV-400 Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab Up to approximately 460 adult participants with c-Met over-expressed OE refractory mCRC will be enrolled in the study in approximately 160 sites in 15-20 countries
In stage 1 participants will receive intravenously IV infused ABBV-400 dose A or B In stage 2 participants will receive the optimal dose of IV infused ABBV-400 or the standard of care SOC LONSURF oral tablets plus IV infused bevacizumab The total study duration will be approximately 4 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None