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Tyrosine Kinase Inhibitor

Nilotinib + Paclitaxel for Advanced Cancer

Phase 1

Recruiting

Led By Alice P Chen, M.D.

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

Willingness to give biopsies for research and have tumors amenable for biopsy procedures or submission of archival tumor biopsy tissue

Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1

Awards & highlights

Study Summary

This trial is testing the safety of combining two drugs, nilotinib and paclitaxel, to see if they can be given safely to people with advanced cancer.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after standard treatment or where no effective therapy exists. They must be in good enough health, not have had certain treatments recently, and agree to use contraception. Excluded are those with specific heart conditions, uncontrolled illnesses, brain metastases requiring medication, pregnant or breastfeeding women, and those with severe allergies to similar drugs.Check my eligibility

What is being tested?

The trial is testing the combination of two cancer drugs: Nilotinib taken orally twice daily (except the first day) and Paclitaxel given by IV once a week for three weeks in each cycle. The goal is to see if Nilotinib can make Paclitaxel more effective against cancer. Participants will undergo regular physical exams, blood tests, scans every 8 weeks and keep a medicine diary.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system's response to the drugs which could affect organs; fatigue; digestive issues like nausea or diarrhea; blood disorders such as low counts leading to increased infection risk; nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to provide tissue samples for research.

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My cancer has worsened despite treatment or there are no standard treatments for it.

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I am 12 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors

Secondary outcome measures

To determine the pharmacokinetics of paclitaxel when administered in combination with nilotinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: treatmentExperimental Treatment1 Intervention

The starting dose of nilotinib will be administered at 300 mg orally BID from cycle 1 day 2 and paclitaxel will be administered IV at 60 mg/m2 at dose level 1 on Days 1, 8, and 15 in 28-day cycles. For cycle 2 on, nilotinib will be administered from day 1. Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,926,062 Total Patients Enrolled

Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

16 Previous Clinical Trials

3,598 Total Patients Enrolled

Media Library

Nilotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02379416 — Phase 1

Solid Tumors Research Study Groups: treatment

Solid Tumors Clinical Trial 2023: Nilotinib Highlights & Side Effects. Trial Name: NCT02379416 — Phase 1

Nilotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02379416 — Phase 1

Frequently Asked Questions

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

Has the administration granted authorization for Nilotinib + Paclitaxel?

"The safety of Nilotinib + Paclitaxel is appraised as a 1, due to the limited evidence that this Phase 1 trial has provided concerning efficacy and security."

Answered by AI

Is this medical investigation actively seeking participants?

"Affirmative. The information located on clinicaltrials.gov implies that enrollment is ongoing for this trial, which commenced April 13th 2015 and was most recently modified November 8th 2022. A total of 70 participants are being accepted from 2 different study sites."

Answered by AI

What medical applications is the combination of Nilotinib and Paclitaxel typically employed for?

"Nilotinib + Paclitaxel is most often prescribed for chronic phase myeloid leukemia patients. Other maladies that can be managed with this particular combination include non-small cell lung carcinoma (nsclc), neoplasm metastasis, and refractory accelerated phase chronic myeloid leukemia."

Answered by AI

Who is the ideal candidate for this medical trial?

"This medical study is searching for 70 people aged 12 to 120 with solid tumors. To qualify, these individuals must demonstrate a life expectancy of over 3 months and an Eastern Cooperative Oncology Group performance rating lower than or equal to 2. Additionally, those interested should have histologically confirmed solid tumours that are refractory to standard therapies known for prolonging survival or treatments where none exist."

Answered by AI

Is the age cap for participants in this trial higher than 45 years of age?

"This trial seeks to enroll those who have surpassed the age of 12 and are yet to reach 120 years."

Answered by AI

How many participants are partaking in this clinical investigation?

"Affirmative. The clinicaltrials.gov database indicates that this medical trial, initiated on April 13th 2015, is presently recruiting participants at 2 different locations requiring a total of 70 volunteers in total."

Answered by AI

What past research has been done looking into the combination of Nilotinib and Paclitaxel?

"Presently, there are 866 trials in operation for Nilotinib + Paclitaxel with 233 of those being Phase 3. Westmead, New South Wales is the primary host site; however, this treatment has been trialled across 47 230 clinical locations worldwide."

Answered by AI

Recent research and studies

PLoS ONEJournal

Imatinib and Nilotinib Reverse Multidrug Resistance in Cancer Cells by Inhibiting the Efflux Activity of the MRP7 (ABCC10)

Shen, Tong, Ye-Hong Kuang, Charles R. Ashby, Yu Lei, Angel Chen, Ying Zhou, Xiang Chen, et al.. 2009. “Imatinib and Nilotinib Reverse Multidrug Resistance in Cancer Cells by Inhibiting the Efflux Activity of the MRP7 (ABCC10)”. Edited by Debbie Fox. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0007520.

Nature Reviews Drug DiscoveryJournal

Utilizing Targeted Cancer Therapeutic Agents in Combination: Novel Approaches and Urgent Requirements

Kummar, Shivanni, Helen X. Chen, John Wright, Susan Holbeck, Myrtle Davis Millin, Joseph Tomaszewski, James Zweibel, Jerry Collins, and James H. Doroshow. 2010. “Utilizing Targeted Cancer Therapeutic Agents in Combination: Novel Approaches and Urgent Requirements”. Nature Reviews Drug Discovery. Springer Science and Business Media LLC. doi:10.1038/nrd3216.

Cancer LettersJournal

Nilotinib Potentiates Anticancer Drug Sensitivity in Murine ABCB1-, ABCG2-, and Abcc10-multidrug Resistance Xenograft Models

Tiwari, Amit K., Kamlesh Sodani, Chun-ling Dai, Alaa H. Abuznait, Satyakam Singh, Zhi-Jie Xiao, Atish Patel, et al.. 2013. “Nilotinib Potentiates Anticancer Drug Sensitivity in Murine ABCB1-, ABCG2-, and Abcc10-multidrug Resistance Xenograft Models”. Cancer Letters. Elsevier BV. doi:10.1016/j.canlet.2012.10.001.

clinicaltrials.govStudy