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NCT03937154 · ClinicalTrials.gov registry record · Phase 3

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

A Phase 3 study of Chemotherapy Induced Thrombocytopenia, sponsored by Amgen.

Active
Registry status
Phase 3
Development phase
145
Enrollment target
20
Study locations

NCT03937154: Active Phase 3 study of Chemotherapy Induced Thrombocytopenia, sponsored by Amgen.

NCT03937154 is a Phase 3 study of Chemotherapy Induced Thrombocytopenia that is active but no longer recruiting, run by Amgen. The registered enrollment target is 145 participants, above the 79-participant average among 4 other Chemotherapy Induced Thrombocytopenia trials with a reported enrollment target (84% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03937154, a Phase 3 study of Chemotherapy Induced Thrombocytopenia, is active but no longer recruiting, sponsored by Amgen.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
145 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

Primary Outcome

No thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L

Interventions

  • DRUG Placebo
  • DRUG Romiplostim

Study Locations (20)

Florida

  • University of Miami School of Medicine - Miami
  • Ocala Oncology Center - Ocala
  • Mid Florida Hematology and Oncology Centers PA - Orange City

Louisiana

  • Christus Saint Frances Cabrini Hospital - Alexandria
  • University Medical Center New Orleans - New Orleans
  • Christus Highland Cancer Treatment Center - Shreveport

California

  • Los Angeles Cancer Network - Anaheim
  • University of California Irvine - Orange

Illinois

  • University of Chicago - Chicago
  • Orchard Healthcare Research Inc - Skokie

Maryland

  • Mercy Medical Center - Baltimore
  • American Oncology Partners, PA - Bethesda

Arkansas

  • Saint Bernards Medical Center - Jonesboro

Colorado

  • Colorado West Healthcare System dba Grand Valley Oncology - Grand Junction

Idaho

  • Saint Alphonsus Regional Medical Center - Boise

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2020-02-26
Est. Completion 2027-05-20
Phase Phase 3
Amgen

558 total trials

What the registry record for NCT03937154 still lists

NCT03937154 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 4 other Chemotherapy Induced Thrombocytopenia trials with a reported enrollment target (84% 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.

NCT03937154 names 20 study sites across 13 states, led by Florida, Louisiana, California.

Frequently Asked Questions

What is clinical trial NCT03937154 about?

NCT03937154 is a clinical study titled "Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer". To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

What is the current status of trial NCT03937154?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2020-02-26. Estimated completion is 2027-05-20.

What conditions does trial NCT03937154 study?

This clinical trial studies the following conditions: Chemotherapy Induced Thrombocytopenia.

What interventions are being tested in trial NCT03937154?

The interventions under investigation include: Placebo (DRUG), Romiplostim (DRUG).

Who is sponsoring clinical trial NCT03937154?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03937154 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03937154, the US trial registry maintained by the National Library of Medicine. NCT03937154 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.