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NCT04585958 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 5
- Study locations
NCT04585958: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04585958 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (73% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04585958, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of deoxyribonucleic acid (DNA) damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (human-epidermal growth factor receptor 2), which is a protein on the surface of some tumor cells. The chemotherapy then enters the cells and blocks DNA replication in the tumor cells with abundant HER2, causing them to die. Giving DS-8201a and olaparib may shrink or stabilize the cancer.
Primary Outcome
Will be measured by Common Terminology Criteria for Adverse Events version (v) 5.0 and analyzed using descriptive statistics.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- PROCEDURE Multigated Acquisition Scan
Study Locations (5)
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Massachusetts
- Dana-Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic in Rochester - Rochester
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT04585958 shows while recruiting
NCT04585958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04585958 lists 5 locations in 5 states (Arizona, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04585958 about?
NCT04585958 is a clinical study titled "Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer". This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum re...
What is the current status of trial NCT04585958?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-05-21. Estimated completion is 2026-12-31.
What conditions does trial NCT04585958 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT04585958?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE).
Who is sponsoring clinical trial NCT04585958?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04585958 being conducted?
This trial has 5 study locations across Arizona, Florida, Massachusetts, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04585958's enrollment target sits among peer trials
55 49th of 92 higher than 44 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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