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NCT04802174 · ClinicalTrials.gov registry record · Phase 1
Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers
A Phase 1 study of Advanced Solid Tumor and SCLC, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04802174: Active Phase 1 study of Advanced Solid Tumor and SCLC, sponsored by National Cancer Institute (NCI).
NCT04802174 is a Phase 1 study of Advanced Solid Tumor and SCLC that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04802174, a Phase 1 study of Advanced Solid Tumor and SCLC, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC) are aggressive neuroendocrine cancers. At first, SCLC and HGNEC respond to chemotherapy. But then they relapse quickly and become resistant to treatment. Researchers want to see if a combination of drugs can help. Objective: To see if the combination of lurbinectedin and berzosertib may be effective to shrink SCLC and HGNEC tumors, and to find the best dose of the combination. Eligibility: Adults ages 18 and older with a solid tumor, SCLC, or HGNEC. Design: Participants will get lurbinectedin by intravenous (IV) catheter on Day 1 of each cycle (1 cycle = 21 days). They will get berzosertib by IV on Days 1 and 2 of each cycle. Participants will continue to receive treatment as long as they are benefiting from treatment. Participants will have physical exams and blood tests. Their symptoms, medicines, and ability to perform their normal activities will be reviewed. Participants will have electrocardiograms to test heart function. Sticky pads will be placed on their chest, arms, and legs. Participants will give blood and hair samples for research. They may have optional tumor biopsies. Participants will have computed tomography (CT) scans to see if the treatment is effective. Participants will have a follow-up visit 1 month after treatment ends. Then they will be followed by email or phone for the rest of their life.
Primary Outcome
Maximum tolerated dose (MTD) of lurbinectedin in combination with berzosertib.
Conditions Studied
Interventions
- DRUG Lurbinectedin
- DRUG Berzosertib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What the registry record for NCT04802174 still lists
NCT04802174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Lurbinectedin is the first listed.
NCT04802174 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04802174 about?
NCT04802174 is a clinical study titled "Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers". Background: Small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC) are aggressive neuroendocrine cancers. At first, SCLC and HGNEC respond to chemotherapy. But then they relapse quickly and become resistant to treatment. Researchers want to see if a combination of drugs can hel...
What is the current status of trial NCT04802174?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-06-01. Estimated completion is 2027-12-01.
What conditions does trial NCT04802174 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, SCLC, Small Cell Cancer, High Grade Neuroendocrine Cancers.
What interventions are being tested in trial NCT04802174?
The interventions under investigation include: Lurbinectedin (DRUG), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT04802174?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04802174 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04802174's enrollment target sits among peer trials
37 173rd of 189 higher than 17 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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