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Kinase Inhibitor
Nilotinib + Paclitaxel for Cancer
Phase 2
Waitlist Available
Led By Geraldine O'Sullivan Coyne
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combo of drugs to treat cancer that's spread/getting worse after taxane therapy. Nilotinib blocks ABL protein & paclitaxel stops cell growth, slowing/killing tumors.
Who is the study for?
Adults with progressive solid cancers previously treated with taxane therapies may join this trial. They must have a safe-to-biopsy tumor or recent tissue sample, no severe peripheral neuropathy, normal heart rhythm (QTcF <= 450 msec), and an ECOG performance status of 0-2. Pregnant or breastfeeding individuals are excluded, as well as those unwilling to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of nilotinib and paclitaxel in patients whose solid tumors continued to grow after taxane treatment. Nilotinib blocks signals that tell cancer cells to multiply, while paclitaxel stops cell division.See study design
What are the potential side effects?
Potential side effects include nerve damage (neuropathy), abnormal heart rhythms due to QT interval prolongation, liver function changes, fatigue from low blood counts, allergic reactions during infusion, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best objective response
Incidence of adverse events
Overall survival
+1 moreSecondary outcome measures
Biopsy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nilotinib hydrochloride monohydrate, paclitaxel)Experimental Treatment6 Interventions
Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the study. Patients also undergo collection of blood samples and tumor biopsy on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Paclitaxel
2011
Completed Phase 4
~5380
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 2
~1720
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,323 Total Patients Enrolled
Geraldine O'Sullivan CoynePrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
239 Total Patients Enrolled
A P ChenPrincipal InvestigatorECOG-ACRIN Cancer Research Group
7 Previous Clinical Trials
550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nilotinib hydrochloride monohydrate, paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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