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NCT02563548 · ClinicalTrials.gov registry record · Phase 1
A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors
A Phase 1 study of Gastric Cancer and NSCLC, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT02563548: Completed Phase 1 study of Gastric Cancer and NSCLC, sponsored by Halozyme Therapeutics.
NCT02563548 is a Phase 1 study of Gastric Cancer and NSCLC that has completed, run by Halozyme Therapeutics. The registered enrollment target is 56 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02563548, a Phase 1 study of Gastric Cancer and NSCLC, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).
Primary Outcome
DLTs were defined as any of the following: i) Any treatment-emergent Grade greater than or equal to (≥) 3 toxicity that was considered related to either PEGPH20 or pembrolizumab or the combination of PEGPH20 and pembrolizumab (nausea, vomiting, MSEs, and diarrhea were considered DLTs only if they reached Grade ≥ 3 despite adequate supportive care measures); ii) Grade 3 musculoskeletal events (MSEs) were considered DLTs only if they did not reduce to Grade ≤ 2 within 48 hours despite therapeutic
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG PEGPH20
Study Locations (20)
California
- California Cancer Associates for Research and Excellence - Encinitas - Encinitas
- University of California San Diego - Moores Cancer Center - La Jolla
- St. Joseph's Hospital - Orange
- University of California - Davis - Sacramento
- St. Joseph's Hospital - Santa Rosa
- Innovative Clinical Research - Whittier
Florida
- Holy Cross Hospitals - Fort Lauderdale
- University of Miami/Sylvester Cancer Center - Miami
- Cleveland Clinic Florida - Weston
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic, Scottsdale, Arizona - Scottsdale
Colorado
- University of Colorado Denver University of Colorado Anschutz Medical Campus - Aurora
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2019-03-26 |
| Phase | Phase 1 |
What the finished NCT02563548 record still lists
NCT02563548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02563548 names 20 study sites across 13 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02563548 about?
NCT02563548 is a clinical study titled "A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors". This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).
What is the current status of trial NCT02563548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2015-10-22. Estimated completion is 2019-03-26.
What conditions does trial NCT02563548 study?
This clinical trial studies the following conditions: Gastric Cancer, NSCLC.
What interventions are being tested in trial NCT02563548?
The interventions under investigation include: Pembrolizumab (DRUG), PEGPH20 (DRUG).
Who is sponsoring clinical trial NCT02563548?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02563548 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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