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NCT04826341 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors
A Phase 1 study of Advanced Solid Tumors and SCLC, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04826341: Recruiting Phase 1 study of Advanced Solid Tumors and SCLC, sponsored by National Cancer Institute (NCI).
NCT04826341 is a Phase 1 study of Advanced Solid Tumors and SCLC that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04826341, a Phase 1 study of Advanced Solid Tumors and SCLC, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help. Objective: To find a safe combination of sacituzumab govitecan and berzosertib and to see if this will cause small cell lung cancer and PARP inhibitor resistant tumors to shrink. Eligibility: People ages 18 and older with a solid tumor, small cell lung cancer, or a homologous recombination-deficient cancer that is resistant to PARP inhibitors Design: Participants will be screened with: Standard clinical exams and tests EKG to test the heart Medical documentation to confirm cancer diagnosis Participants will get sacituzumab govitecan by vein on days 1 and 8 of each 21-day cycle. They will get berzosertib by vein on days 2 and 9. Treatment will continue as long as they can tolerate the drugs and their tumors are either stable or getting better. Before treatment and at least once per cycle, participants will have a physical exam and blood tests. Before treatment and every 2 or 3 cycles, they will have a CT scan. They will have a contrast agent injected into a vein for the scan. Participants will give blood and hair samples and tumor biopsies for research. Biopsies will be taken with a small needle under imaging guidance. After they stop treatment, participants will have a visit 1 month later. They will then be contacted by phone or email every 3 months for the rest of their lives....
Primary Outcome
In phase II, in each cohort, the fraction of participants who experience a PR or CR will be reported along with a 95% confidence interval.
Conditions Studied
Interventions
- DRUG Sacituzumab Govitecan
- DRUG Berzosertib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT04826341 shows while recruiting
NCT04826341 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (39% lower).
The record links to 3 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab Govitecan is the first listed.
NCT04826341 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04826341 about?
NCT04826341 is a clinical study titled "A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors". Background: Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help. Objective: To find a safe combination of sacituzumab govitecan and berzo...
What is the current status of trial NCT04826341?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2021-09-20. Estimated completion is 2027-03-01.
What conditions does trial NCT04826341 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, SCLC, HRD Cancer.
What interventions are being tested in trial NCT04826341?
The interventions under investigation include: Sacituzumab Govitecan (DRUG), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT04826341?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04826341 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 NCT04826341's enrollment target sits among peer trials
120 71st of 144 higher than 72 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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