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NCT02379416 · ClinicalTrials.gov registry record · Phase 1
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02379416: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02379416 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02379416, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Background: \- Researchers want to find better ways to treat cancer. One drug that treats cancer is paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if another drug, nilotinib, helps paclitaxel work better. Objective: \- To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be given safely to people. Eligibility: \- Adults at least 18 years old with advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: * Participants will be screened with tests they usually get in their cancer care: medical history, physical exam, blood and urine tests, heart test, and scans. * Participants will take the two study drugs in 28-day cycles. They will keep a medicine diary. * Nilotinib will be taken by mouth twice every day except day 1 of the first cycle. * Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will usually be done at the clinic. * Most participants will have a weekly study visit every week for cycle 1, then the first 3 weeks of other cycles. They will have: * Physical exam at every visit. * Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles. * Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or they may be ultrasounds, where a wand is pressed on the skin with gel on it. * Around 30 days after stopping the study drugs, participants will be called to discuss any side effects.
Primary Outcome
Safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors
Interventions
- DRUG Nilotinib + Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-04-13 |
| Est. Completion | 2026-02-25 |
| Phase | Phase 1 |
What the finished NCT02379416 record still lists
NCT02379416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Nilotinib + Paclitaxel is the first listed.
NCT02379416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02379416 about?
NCT02379416 is a clinical study titled "Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors". Background: \- Researchers want to find better ways to treat cancer. One drug that treats cancer is paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if another drug, nilotinib, helps paclitaxel work better. Objective: \- To test the safety of nilotinib plus pac...
What is the current status of trial NCT02379416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2015-04-13. Estimated completion is 2026-02-25.
What interventions are being tested in trial NCT02379416?
The interventions under investigation include: Nilotinib + Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02379416?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02379416's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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