Trial · NCT04868773
Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
NCT04868773, Phase 1, Completed, University of California, Irvine
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy. Trials, record NCT04868773. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04868773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy
- NCT number
- NCT04868773
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of California, Irvine
- Conditions
- Colorectal Cancer, Colorectal Carcinoma, Metastatic Cancer, CRC
- Interventions
- Cabozantinib, TAS-102
- First posted
- 2021-05-03
- Last updated
- 2026-04-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicity [DLT] | From the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year. | To determine the Dose Limiting Toxicity (DLT) at Cycle 1 Day 28. A DLT is defined as the occurrence of specific toxicities within the DLT treatment period if judged by the Investigator to be possibly, probably, or definitely related to cabozantinib or TAS-102. |
| Primary | Recommended Phase 2 Dose [RP2D] | From the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year. | To determine the recommended Phase 2 Dose (RP2D) of cabozantinib in combination with TAS-102 in patients with metastatic colorectal carcinoma (mCRC) based on a 3+3 study design. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. | To evaluate the tolerability of administering cabozantinib in combination with TAS-102 in patients with metastatic colorectal cancer from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0. |
| Secondary | Progression-Free Survival of Patients who Received Cabozantinib with TAS-102 | From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
| Secondary | Overall Survival of Patients who Received Cabozantinib with TAS-102 | From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first | To evaluate overall survival in patients with metastatic colorectal cancer receiving cabozantinib in combination with TAS-102. |
| Secondary | Number of Participants with Objective Response Rate | From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. | The ORR is determined by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) in patients with measurable disease, progression-free, safety regardless of grade and overall survival. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38103947 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04868773
GET https://conductscience.org/api/trials/v1/NCT04868773/registered