OncoMatch/Clinical Trials/NCT04449549
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel
Is NCT04449549 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nilotinib and Paclitaxel for neoplasms.
Treatment: Nilotinib and Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count >=1,500/mcL; Platelets >=100,000/mcL
Kidney function
creatinine <=1.5 X institutional ULN OR creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels >1.5 mg/dL
Liver function
Total bilirubin <=1.5 X institutional ULN; AST(SGOT)/ALT(SGPT) <=3 X institutional ULN; <= 5.0 x ULN in patients with liver metastases
Cardiac function
QTcF interval of >=450 msec at study entry; congenital long QT syndrome [excluded]
Patients must have normal organ and marrow function as defined below: Absolute neutrophil count >=1,500/mcL; Platelets >=100,000/mcL; Total bilirubin <=1.5 X institutional ULN; AST(SGOT)/ALT(SGPT) <=3 X institutional ULN; <= 5.0 x ULN in patients with liver metastases; creatinine <=1.5 X institutional ULN OR creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels >1.5 mg/dL. QTcF interval of >=450 msec at study entry; congenital long QT syndrome [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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