Actively Recruiting
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
Led by National Cancer Institute (NCI) · Updated on 2026-05-12
82
Participants Needed
1
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. 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. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs.
CONDITIONS
Official Title
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a histologically confirmed rare solid tumor that has progressed after standard therapy known to prolong survival or for which no standard treatment options exist.
- Patients must be 18 years or older.
- Patients must have an ECOG performance status of 0 to 2.
- Patients must have normal organ and marrow function including adequate neutrophil count, platelet count, liver enzymes, and kidney function as specified.
- Women of childbearing potential and men must agree to use effective contraception prior to and during the study and for at least 3 months after treatment ends.
- Patients must have completed radiation therapy or major surgery at least 3 weeks prior, or chemotherapy or biologic therapy at least 3 weeks or 5 half-lives prior (6 weeks for nitrosoureas and mitomycin C), with recovery from prior treatment toxicities.
- Optional tumor biopsies are permitted; archival tumor tissue collected within 3 months prior to registration may be used if no therapy was given since.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible, with a viral load test done within 28 days before enrollment.
You will not qualify if you...
- QTcF interval of 450 msec or more at study entry or congenital long QT syndrome.
- Sensory or motor neuropathy grade 2 or higher.
- Receiving any other investigational agents.
- Known primary central nervous system malignancy or symptomatic CNS metastases, except for certain asymptomatic or treated cases meeting specific criteria.
- History of allergic reactions to compounds similar to nilotinib or paclitaxel.
- Uncontrolled illnesses including serious untreated infections, symptomatic respiratory failure, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric or social conditions limiting compliance.
- Pregnant women are excluded; breastfeeding must be discontinued before treatment and avoided during and for 3 months after treatment due to potential risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
B
Brooksley F Augustine
CONTACT
A
Alice P Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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