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NCT04449549 · ClinicalTrials.gov registry record · Phase 2
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
A Phase 2 study of Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 1
- Study location
NCT04449549: Recruiting Phase 2 study of Neoplasms, sponsored by National Cancer Institute (NCI).
NCT04449549 is a Phase 2 study of Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 82 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04449549, a Phase 2 study of Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs.
Primary Outcome
If at least 4/30 patients experience an objective response, defined as a complete or partial response by RECIST 1.1, the combination of nilotinib and paclitaxel will be considered promising. This design provides approximately 88% power to reject a null ORR of 0.05 when the true ORR is 0.2 (with one-sided type-I error of approximately 0.062).
Conditions Studied
Interventions
- DRUG Nilotinib and Paclitaxel
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2026-04-08 |
| Phase | Phase 2 |
What NCT04449549 shows while recruiting
NCT04449549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib and Paclitaxel is the first listed.
NCT04449549 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04449549 about?
NCT04449549 is a clinical study titled "Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel". Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see i...
What is the current status of trial NCT04449549?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2020-08-24. Estimated completion is 2026-04-08.
What conditions does trial NCT04449549 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT04449549?
The interventions under investigation include: Nilotinib and Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04449549?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04449549 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04449549's enrollment target sits among peer trials
82 79th of 158 higher than 80 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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