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NCT04616183 · ClinicalTrials.gov registry record · Phase 1
LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
A Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Colorectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04616183: Active Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Colorectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04616183 is a Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 46 participants, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616183, a Phase 1 study of Metastatic Colorectal Carcinoma and Stage III Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and/or has spread to other places in the body (metastatic). Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LY3214996 and cetuximab alone or in combination with abemaciclib may help treat patients with colorectal cancer.
Primary Outcome
Response rate will be calculated based on the number of patients in the evaluable population experiencing a radiographic response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (either CR or PR) relative to the total number of patients in the efficacy evaluable population. A 95% confidence interval will be estimated around this population.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Abemaciclib
- DRUG ERK1/2 Inhibitor LY3214996
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04616183 still lists
NCT04616183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 87-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (47% lower).
The record links to 10 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT04616183 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04616183 about?
NCT04616183 is a clinical study titled "LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer". This phase Ib/II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and/or has spread to ...
What is the current status of trial NCT04616183?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2020-12-02. Estimated completion is 2028-12-31.
What conditions does trial NCT04616183 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT04616183?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Abemaciclib (DRUG), ERK1/2 Inhibitor LY3214996 (DRUG).
Who is sponsoring clinical trial NCT04616183?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616183 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04616183's enrollment target sits among peer trials
46 15th of 22 higher than 8 of 22 other Metastatic Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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