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NCT03983993 · ClinicalTrials.gov registry record · Phase 2
Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
A Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT03983993: Active Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by Emory University.
NCT03983993 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 26 participants, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03983993, a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.
Primary Outcome
The efficacy, as measured by clinical benefit rate (CBR), will be assessed for the total number of patients enrolled. CBR = (Complete Response + Partial Response + Stable Disease \[CR +PR + SD\] rate. Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.
Conditions Studied
Interventions
- BIOLOGICAL Panitumumab
- DRUG Niraparib
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT03983993 still lists
NCT03983993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (76% lower).
The record links to 6 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Panitumumab is the first listed.
NCT03983993 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03983993 about?
NCT03983993 is a clinical study titled "Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer". This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with mo...
What is the current status of trial NCT03983993?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-10-15. Estimated completion is 2026-12-01.
What conditions does trial NCT03983993 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Microsatellite Stable Colorectal Carcinoma, MSI-H Colorectal Cancer, Advanced Microsatellite Stable Colorectal Carcinoma, Microsatellite Stable.
What interventions are being tested in trial NCT03983993?
The interventions under investigation include: Panitumumab (BIOLOGICAL), Niraparib (DRUG).
Who is sponsoring clinical trial NCT03983993?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03983993 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03983993's enrollment target sits among peer trials
26 15th of 22 higher than 8 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 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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