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NCT03578081 · ClinicalTrials.gov registry record · Phase 3
Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
A Phase 3 study of Malignant Neoplasm, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 690
- Enrollment target
- 20
- Study locations
NCT03578081: Completed Phase 3 study of Malignant Neoplasm, sponsored by Alliance for Clinical Trials in Oncology.
NCT03578081 is a Phase 3 study of Malignant Neoplasm that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 690 participants, above the 502-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (37% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03578081, a Phase 3 study of Malignant Neoplasm, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 690 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.
Primary Outcome
The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Sime
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Olanzapine
- DRUG Palonosetron Hydrochloride
- DRUG Ondansetron Hydrochloride
- DRUG Fosaprepitant Dimeglumine
Study Locations (20)
California
- PCR Oncology - Arroyo Grande
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- Tibor Rubin VA Medical Center - Long Beach
- Contra Costa Regional Medical Center - Martinez
- Alta Bates Summit Medical Center - Summit Campus - Oakland
- Bay Area Tumor Institute - Oakland
- Desert Regional Medical Center - Palm Springs
- Epic Care Cyberknife Center - Walnut Creek
Arizona
- Kingman Regional Medical Center - Kingman
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- The Medical Center of Aurora - Aurora
- Boulder Community Hospital - Boulder
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 3 |
What the finished NCT03578081 record still lists
NCT03578081 is an interventional study that assigns participants to a tested intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap, above the 502-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03578081 names 20 study sites across 6 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03578081 about?
NCT03578081 is a clinical study titled "Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy". This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patie...
What is the current status of trial NCT03578081?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2018-11-20. Estimated completion is 2023-05-01.
What conditions does trial NCT03578081 study?
This clinical trial studies the following conditions: Malignant Neoplasm.
What interventions are being tested in trial NCT03578081?
The interventions under investigation include: Dexamethasone (DRUG), Olanzapine (DRUG), Palonosetron Hydrochloride (DRUG), Ondansetron Hydrochloride (DRUG), Fosaprepitant Dimeglumine (DRUG).
Who is sponsoring clinical trial NCT03578081?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03578081 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03578081's enrollment target sits among peer trials
690 8th of 59 higher than 52 of 59 other Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant 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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