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Tyrosine Kinase Inhibitor

Nilotinib + Paclitaxel for Rare Cancers

Phase 2

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

- Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis

- Epithelial tumors of major salivary glands

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing if nilotinib and paclitaxel will help people with rare cancers. People with rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists, may be eligible. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle.

Who is the study for?

Adults aged 18+ with rare, advanced cancers that have worsened after standard treatment or for which no effective therapy exists. Participants must be in good health otherwise, with proper organ and marrow function, and not pregnant or breastfeeding. They should agree to use contraception during the trial and for some time after.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs—Nilotinib (oral capsule) and Paclitaxel (IV infusion)—to see if they can shrink or halt the growth of rare cancers. The drugs are given in cycles lasting 28 days, with close monitoring through tests and scans.See study design

What are the potential side effects?

Possible side effects include tiredness, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk, heart problems due to abnormal rhythms, 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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My cancer is a type of penile cancer known as squamous cell carcinoma.

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I have a tumor in my salivary gland.

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I have peritoneal mesothelioma.

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My cancer is a type of squamous cell in the urinary or genital area.

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My kidney function, measured by creatinine or clearance, is within the required range.

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I have gallbladder cancer.

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I haven't had any cancer treatment since my tumor sample was taken.

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I have been diagnosed with Merkel cell carcinoma.

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I have been diagnosed with a malignant giant cell tumor.

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My kidney function, measured by creatinine or clearance, is within the required range.

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My cancer is a type of transitional cell carcinoma, but not from the kidney, bladder, or related areas.

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I have basal cell carcinoma.

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My cancer is in the bile ducts outside the liver.

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I have fibromixoma or low-grade mucinous adenocarcinoma of the appendix or ovary.

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My lung cancer is of the sarcomatoid type.

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I have been diagnosed with uterine leiomyosarcoma.

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I have been diagnosed with endometrial carcinosarcoma.

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I have an adrenal cortical tumor.

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My cancer is a type of adenocarcinoma in the urinary system, not including prostate cancer.

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I have been diagnosed with a malignant pheochromocytoma.

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My condition is either apocrine tumors or Extramammary Paget's Disease.

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My cancer originates from the salivary glands and could be in areas like the head, neck, lung, or breast.

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My ovarian cancer is of the clear cell type.

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I have been diagnosed with angiosarcoma.

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I have been diagnosed with a PEComa.

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I have been diagnosed with thymic carcinoma.

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I have been diagnosed with sarcoma in my bones or soft tissues.

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My cervical cancer is the clear cell type.

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I have a trophoblastic tumor.

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I have a tumor related to my nerve sheath or NF1.

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I have lymphoma.

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My pancreatic cancer is a rare type, like acinar, mucinous, or serous.

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My prostate cancer has changed into a more aggressive type known as small-cell.

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I have a cancer that started in my tooth or jaw area.

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I have a specific type of lung cancer known as bronchoalveolar carcinoma.

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My cancer is a specific type called spindle cell carcinoma located in my kidney, pelvis, or ureter.

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My cancer is a type of neuroendocrine tumor found in the lung.

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My cancer originates from the pituitary, thyroid, parathyroid gland, or adrenal cortex.

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My cancer is located in the nasal area or sinuses.

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I have been diagnosed with chordoma.

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I have a desmoid tumor.

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I have been diagnosed with adenoid cystic carcinoma.

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My breast cancer is metaplastic.

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My cancer is a type called clear cell endometrial.

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My cancer is a high-grade neuroendocrine carcinoma.

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I have been diagnosed with gestational trophoblastic disease.

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My condition is small cell carcinoma of the ovary, hypercalcemic type.

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My kidney cancer is of the papillary type.

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

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My rare solid tumor cancer has not responded to standard treatments.

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My cancer is a type that started in the digestive system and is not well-defined.

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My cancer is a type of adenocarcinoma located in the small intestine.

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My cancer is a type of squamous cell carcinoma located in the digestive system.

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I have cancer in the bile ducts inside my liver.

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My ovarian cancer is not of the epithelial type.

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My cancer originates from testicular cells or germ cells outside the gonads.

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I have a pancreatic neuroendocrine tumor.

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I have been diagnosed with anal cancer.

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I have been diagnosed with pleural mesothelioma.

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I am 18 years old or older.

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I have been diagnosed with vulvar cancer.

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My cancer's origin is unknown.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective response

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Nilotinib will be administered at 300 mg orally BID; Paclitaxel will be administered IV at 80 mg/m2 on Days 1, 8, and 15 in 28-day cycles.

0 / 62Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,820 Total Patients Enrolled

3 Trials studying Tumors

1,244 Patients Enrolled for Tumors

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

16 Previous Clinical Trials

3,634 Total Patients Enrolled

Media Library

Nilotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04449549 — Phase 2

Tumors Clinical Trial 2023: Nilotinib Highlights & Side Effects. Trial Name: NCT04449549 — Phase 2

Nilotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04449549 — Phase 2

Frequently Asked Questions

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

Is participation in this experiment open to the public?

"To take part in this medical research, 34 individuals must meet the criteria of having a cancer diagnosis and being between 18 to 120 years old."

Answered by AI

What is the current enrollment capacity for this trial?

"Affirmative. According to clinicaltrials.gov, this experiment is still open for enrollment which began on August 24th 2020 and was last modified on the 5th of August 2022. The study requires 34 volunteers from a single site to be recruited in order to continue its investigation."

Answered by AI

Is there an age restriction for participants of this research?

"This trial seeks participants aged between 18 and 120. In contrast, 325 separate trials are available for minors while 3038 clinical studies are offered to patients that have surpassed the age of 65."

Answered by AI

Are there any adverse effects to Paclitaxel treatment?

"Paclitaxel was assigned a score of 2, as Phase II trials have only provided preliminary evidence on the drug's safety. No data exists yet that supports its efficacy."

Answered by AI

What prior research has been conducted relating to Paclitaxel?

"At this moment, 865 clinical studies are researching Paclitaxel. Of these active trials, 233 have advanced to Phase 3 of their investigation. Most research for this treatment is conducted in Adelaide, South Australia; however there are over 47 thousand locations worldwide running experiments with the drug."

Answered by AI

Is enrollment for this research study still open?

"Affirmative. The clinical trials website confirms that the recruitment for this medical study, which was initially posted on August 24th 2020, is ongoing. A total of 34 participants are required from a single location."

Answered by AI

What conditions are usually treated with Paclitaxel?

"Paclitaxel is typically prescribed to treat chronic myeloid leukemia in its chronic phase, as well as non-small cell lung carcinoma (nsclc), neoplasm metastasis and refractory accelerated phase chronic myeloid leukemia."

Answered by AI

Recent research and studies

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.

clinicaltrials.govStudy

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

2020. "Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04449549.

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