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Kinase Inhibitor

Nilotinib + Paclitaxel for Cancer

Q: Do the potential risks of taking nilotinib hydrochloride monohydrate and paclitaxel outweigh its benefits?

Nilotinib hydrochloride monohydrate and paclitaxel have only been backed by safety data, so our team rated the treatment a 2 on their scale.

Q: To what extent has patient participation been seen in this research endeavor?

Affirmative. According to clinicaltrials.gov, the medical research project posted on June 7th 2023 is presently enrolling participants. 40 individuals need to be enrolled from a sole trial site prior to closing registration.

Q: Does this clinical trial still have an open enrollment period?

Confirmed. The information available on clinicaltrials.gov reveals that this study, initially posted on June 7th 2023, is actively searching for participants to join the trial. 40 people are required at one medical site for enrolment.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more

Secondary 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

~850

Paclitaxel

2011

Completed Phase 4

~5380

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,627 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

Nilotinib Hydrochloride Monohydrate (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05554341 — Phase 2

Solid Tumors Research Study Groups: Treatment (nilotinib hydrochloride monohydrate, paclitaxel)

Solid Tumors Clinical Trial 2023: Nilotinib Hydrochloride Monohydrate Highlights & Side Effects. Trial Name: NCT05554341 — Phase 2

Nilotinib Hydrochloride Monohydrate (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554341 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the potential risks of taking nilotinib hydrochloride monohydrate and paclitaxel outweigh its benefits?

"Nilotinib hydrochloride monohydrate and paclitaxel have only been backed by safety data, so our team rated the treatment a 2 on their scale."

Answered by AI

To what extent has patient participation been seen in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the medical research project posted on June 7th 2023 is presently enrolling participants. 40 individuals need to be enrolled from a sole trial site prior to closing registration."

Answered by AI

Does this clinical trial still have an open enrollment period?

"Confirmed. The information available on clinicaltrials.gov reveals that this study, initially posted on June 7th 2023, is actively searching for participants to join the trial. 40 people are required at one medical site for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial

2023. "Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554341.

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