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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

Must not have

QTcF interval of less than 450 msec at study entry; congenital long QT syndrome

Sensory/motor neuropathy less than or equal to Grade 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's electrical activity is normal, and I don't have a genetic heart condition.

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My nerve damage does not severely affect my daily activities.

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I have active brain tumors or cancer in the lining of my brain.

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I am HIV-positive and on combination antiretroviral therapy.

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I do not have any uncontrolled illnesses.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met