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NCT00418678 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
A Phase 4 study, sponsored by Veeda Oncology.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT00418678: Clinical Trial Phase 4 study, sponsored by Veeda Oncology.
NCT00418678 is a Phase 4 study that was terminated before completion, run by Veeda Oncology. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00418678, a Phase 4 study, was terminated before completion, sponsored by Veeda Oncology.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy. Phase 1 of study: Prior to the first dose of chemotherapy, patients will be instructed on how to complete their patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for pain. In addition, the diary will include a section to list their current pain medications (see Sample Patient Diary in Appendix I). After being instructed, patients will complete the VAS for nausea and for pain, as well as listing their current pain medications. Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonist/corticosteroid regimen. Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day, patients will complete a diary entry pertaining to the preceding 24 hours. The entry will include the number and time of any emetic episodes, any antiemetic rescue medications used, VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the entry will include the above daily parameters but will also include a VAS for pain. In addition, the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in Appendix II). Patients who either have at least one vomiting episode or at least one report of significant nausea (VAS \> 25 mm) during the first 5-day study period will be eligible for the second phase of the study. Phase 2 of the study: Patients in the second phase will receive a second cycle of the same chemotherapy. The antiemetic regimen for the
Interventions
- DRUG Cesamet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
Why NCT00418678 stopped before completion
NCT00418678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Cesamet is the first listed.
NCT00418678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00418678 about?
NCT00418678 is a clinical study titled "A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting". This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 for eligible treatment regimens.) The study will take place during the first 2 cycles of chemotherapy...
What is the current status of trial NCT00418678?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2006-08. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00418678?
The interventions under investigation include: Cesamet (DRUG).
Who is sponsoring clinical trial NCT00418678?
This trial is sponsored by Veeda Oncology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00418678's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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