Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868773
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2021-04-27
Brief Title:
Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase 1 Study of the Combination of Cabozantinib With TrifluridineTipiracil TAS-102 in Patients With Metastatic Colorectal Adenocarcinoma mCRC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a phase I clinical trial assessing the safety and recommended phase II dose of cabozantinib in combination with trifluridinetipiracil TAS102 in patients with metastatic colorectal carcinoma mCRC
Detailed Description:
Patients with histologically proven colorectal adenocarcinoma not amenable to curative treatment will be eligible to participate for this study After meeting the eligibility criteria patients will be given a IP regimen consisting of cabozantinib 20 - 40 mg given orally everyday for 28 days trifluridinetipiracil TAS102 25 - 35 mgm2 on Days 1 - 5 and Days 8 - 12 every 28 days and peg-filgrastim 6 mg subcutaneously on Day 13 every 28 days Tumor assessments will be completed by CTMRI every 8 weeks during the first year of treatment and every 3 months after the first year until patient comes off treatment
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 |
|---|---|---|---|
| UCI 20-134 | OTHER | CFCCC | None |