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NCT04068194 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT04068194: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04068194 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 103 participants, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04068194, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.
Primary Outcome
Will be determined by the occurrence of dose-limiting toxicities defined as the occurrence of one or more grade 3 adverse events that delays treatment for more than 7 days, or any grade 4-5 adverse events.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- RADIATION Hypofractionated Radiation Therapy
- DRUG Avelumab
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Colorado
- UCHealth University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
What the registry record for NCT04068194 still lists
NCT04068194 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (50% 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.
NCT04068194 names 20 study sites across 3 states, led by Connecticut, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04068194 about?
NCT04068194 is a clinical study titled "Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies". This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Pepos...
What is the current status of trial NCT04068194?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2020-04-07. Estimated completion is 2027-07-01.
What conditions does trial NCT04068194 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v8.
What interventions are being tested in trial NCT04068194?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Hypofractionated Radiation Therapy (RADIATION), Avelumab (DRUG).
Who is sponsoring clinical trial NCT04068194?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04068194 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04068194's enrollment target sits among peer trials
103 24th of 92 higher than 69 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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