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NCT03362177 · ClinicalTrials.gov registry record · Phase 3
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
A Phase 3 study of Chemotherapy Induced Thrombocytopenia, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT03362177: Completed Phase 3 study of Chemotherapy Induced Thrombocytopenia, sponsored by Amgen.
NCT03362177 is a Phase 3 study of Chemotherapy Induced Thrombocytopenia that has completed, run by Amgen. The registered enrollment target is 165 participants, above the 74-participant average among 4 other Chemotherapy Induced Thrombocytopenia trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03362177, a Phase 3 study of Chemotherapy Induced Thrombocytopenia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
Primary Outcome
Participants met the criteria of the primary endpoint if there was no thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-trial chemotherapy regimen (cycles were up to 3 weeks). A thrombocytopenia-induced modification was defined as any dose reduction, dose delay, dose omission, and/or early chemotherapy treatment discontinuation due to low platelet counts less than 100 x 10\^9/L. The 95% confidence interval (CI) is bas
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Romiplostim
Study Locations (20)
Florida
- Mid Florida Hematology and Oncology Centers PA - Orange City
- Oncology and Hematology Associates of West Broward, PA - Tamarac
- Cleveland Clinic Florida - Weston
Louisiana
- Christus Saint Frances Cabrini Hospital - Alexandria
- University Medical Center New Orleans - New Orleans
- Christus Highland Cancer Treatment Center - Shreveport
California
- Pacific Cancer Medical Center Inc - Anaheim
- University of California Irvine - Orange
Maryland
- Mercy Medical Center - Baltimore
- American Oncology Partners, PA - Bethesda
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Beth Israel Deaconess Medical Center - Boston
New Jersey
- Morristown Medical Center - Morristown
- Regional Cancer Care Associates - Sparta
Arkansas
- Saint Bernards Medical Center - Jonesboro
Colorado
- Colorado West Healthcare System dba Grand Valley Oncology - Grand Junction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2025-01-09 |
| Phase | Phase 3 |
What the finished NCT03362177 record still lists
NCT03362177 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 74-participant average among 4 other Chemotherapy Induced Thrombocytopenia trials with a reported enrollment target (123% higher).
The record links to 1 condition, with Chemotherapy Induced Thrombocytopenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03362177 names 20 study sites across 12 states, led by Florida, Louisiana, California.
Frequently Asked Questions
What is clinical trial NCT03362177 about?
NCT03362177 is a clinical study titled "Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer". Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
What is the current status of trial NCT03362177?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2019-09-30. Estimated completion is 2025-01-09.
What conditions does trial NCT03362177 study?
This clinical trial studies the following conditions: Chemotherapy Induced Thrombocytopenia.
What interventions are being tested in trial NCT03362177?
The interventions under investigation include: Placebo (OTHER), Romiplostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT03362177?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03362177 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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