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NCT03448718 · ClinicalTrials.gov registry record · Phase 2
Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
A Phase 2 study of Metastatic Urothelial Cancer, sponsored by Matthew Galsky.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 7
- Study locations
NCT03448718: Completed Phase 2 study of Metastatic Urothelial Cancer, sponsored by Matthew Galsky.
NCT03448718 is a Phase 2 study of Metastatic Urothelial Cancer that has completed, run by Matthew Galsky. The registered enrollment target is 19 participants, below the 649-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03448718, a Phase 2 study of Metastatic Urothelial Cancer, has completed, sponsored by Matthew Galsky.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatment with olaparib.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Conditions Studied
Interventions
- DRUG Olaparib
Study Locations (7)
Illinois
- University of Chicago Medical Center - Chicago
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Michigan
- Karmanos Cancer Center (Wyane State University) - Detroit
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Tennessee
- Vanderbilt-Ingran Cancer Center - Nashville
Utah
- Huntsman Cancer Institute University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2021-10-15 |
| Phase | Phase 2 |
What the finished NCT03448718 record still lists
NCT03448718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 649-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 1 intervention - of which Olaparib is the first listed.
NCT03448718 lists 7 locations in 7 states (Illinois, Maryland, Michigan).
Frequently Asked Questions
What is clinical trial NCT03448718 about?
NCT03448718 is a clinical study titled "Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations". This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatmen...
What is the current status of trial NCT03448718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2018-04-17. Estimated completion is 2021-10-15.
What conditions does trial NCT03448718 study?
This clinical trial studies the following conditions: Metastatic Urothelial Cancer.
What interventions are being tested in trial NCT03448718?
The interventions under investigation include: Olaparib (DRUG).
Who is sponsoring clinical trial NCT03448718?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03448718 being conducted?
This trial has 7 study locations across Illinois, Maryland, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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