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NCT02595931 · ClinicalTrials.gov registry record · Phase 1
M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT02595931: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02595931 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595931, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will be defined as the highest dose level at which =\< 20% patients experience dose limiting toxicity. A logistic regression model will be used to determine the MTD using all patients.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Irinotecan Hydrochloride
- DRUG Berzosertib
- PROCEDURE Biopsy Specimen
Study Locations (20)
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Stanford Cancer Institute Palo Alto - Palo Alto
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Mount Zion - San Francisco
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2027-03-06 |
| Phase | Phase 1 |
What the registry record for NCT02595931 still lists
NCT02595931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (68% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02595931 names 20 study sites across 7 states, led by California, Missouri, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02595931 about?
NCT02595931 is a clinical study titled "M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of t...
What is the current status of trial NCT02595931?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2016-07-22. Estimated completion is 2027-03-06.
What conditions does trial NCT02595931 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Stage III Lung Cancer AJCC v8, Metastatic Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT02595931?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Irinotecan Hydrochloride (DRUG), Berzosertib (DRUG), Biopsy Specimen (PROCEDURE).
Who is sponsoring clinical trial NCT02595931?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595931 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02595931's enrollment target sits among peer trials
66 39th of 92 higher than 53 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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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