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Tyrosine Kinase Inhibitor

Paclitaxel + Nilotinib for Cancer

Phase 2
Recruiting
Led By Andrew M Blakely, 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
Histological confirmation of non-mucinous peritoneal carcinomatosis from specified primary sources by the Laboratory of Pathology, NCI
Assessed to not be candidates for cytoreductive surgery, with PCI score > 30 on screening laparoscopy or with extensive small bowel serosal involvement
Must not have
Sensory/motor neuropathy >= Grade 2
More than 3 liters of ascites present at initial laparoscopy, or history of more than two paracentesis procedures in the 30 days prior to initial laparoscopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at peritoneal disease relapse from cr or peritoneal disease progression, or death, for up to 3 years after completion of therapy
Awards & highlights

Summary

This trial is testing a combination of oral nilotinib plus paclitaxel given by IV and directly into the abdomen to see if it can reduce tumors enough for people to have surgery.

Who is the study for?
Adults over 18 with peritoneal carcinomatosis from certain cancers, not suitable for surgery due to widespread disease. Must have tried at least one chemotherapy without success and be physically able to participate (ECOG <=2). They should have functioning organs and marrow, agree to use contraception if applicable, and not breastfeed during the trial.Check my eligibility
What is being tested?
The study is testing a new treatment combining oral nilotinib with paclitaxel administered intravenously (IV) and directly into the abdomen (IP) in hopes of shrinking tumors enough for surgery. Participants will undergo multiple cycles of this treatment along with regular health assessments including laparoscopies.See study design
What are the potential side effects?
Potential side effects include reactions related to IV/IP administration of paclitaxel such as abdominal pain or complications, allergic reactions, nerve issues like numbness or tingling (neuropathy), fatigue, blood count changes increasing infection risk, heart rhythm problems due to nilotinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer, which started in the peritoneum and is not mucinous, has been confirmed by pathology.
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I cannot have surgery to reduce my tumor, due to extensive spread or involvement.
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My cancer's growth can be tracked with specific medical tests.
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I am 18 years old or older.
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I have had chemotherapy but my cancer did not respond.
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I can take care of myself but may 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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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have had a lot of fluid in my abdomen or more than two fluid removal procedures recently.
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I am not taking medication that affects heart rhythm or interferes with certain liver enzymes.
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My liver is severely damaged (Child-Pugh Class C).
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My heart's electrical activity (QTcF interval) is normal or I don't have congenital long QT syndrome.
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I have not had chemotherapy directly into my abdomen in the last 6 months.
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I have HIV with a detectable viral load or take medications that affect heart rhythm or interact with certain enzymes.
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I haven't had chemotherapy or major surgery in the last 12 weeks.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at peritoneal disease relapse from cr or peritoneal disease progression, for up to 3 years after completion of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at peritoneal disease relapse from cr or peritoneal disease progression, for up to 3 years after completion of therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate efficacy of bidirectional chemotherapy using intraperitoneal and intravenous paclitaxel and oral nilotinib by calculating the rate of downstaging of peritoneal disease burden to become resectable, based on Peritoneal Carcinomatosis Inde...
Secondary outcome measures
Assess clinicopathologic response to therapy
Determine peritoneal progression-free survival (pPFS)
Evaluate participants quality of life (QOL)
+3 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/ IP Catheter Placement and Bidirectional ChemotherapyExperimental Treatment2 Interventions
IP and IV paclitaxel administration with oral nilotinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Nilotinib
2005
Completed Phase 4
~2670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,331 Total Patients Enrolled
13 Trials studying Peritoneal Carcinomatosis
413 Patients Enrolled for Peritoneal Carcinomatosis
Andrew M Blakely, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
460 Total Patients Enrolled
1 Trials studying Peritoneal Carcinomatosis
60 Patients Enrolled for Peritoneal Carcinomatosis

Media Library

Nilotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05185947 — Phase 2
Peritoneal Carcinomatosis Research Study Groups: 1/ IP Catheter Placement and Bidirectional Chemotherapy
Peritoneal Carcinomatosis Clinical Trial 2023: Nilotinib Highlights & Side Effects. Trial Name: NCT05185947 — Phase 2
Nilotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05185947 — Phase 2
~47 spots leftby Dec 2028
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