OncoMatch/Clinical Trials/NCT06540963
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Is NCT06540963 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tipifarnib and Naxitamab for neuroblastoma.
Treatment: Tipifarnib · Naxitamab — The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification
Prior therapy
Must have received: multi-drug induction chemotherapy — induction
at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment/neuroblastoma protocol
Cannot have received: naxitamab (naxitamab)
Exception: Previous Gr.4 allergic or anaphylactic reaction to naxitamab, leading to the discontinuation of naxitamab during prior therapy
Previous Gr.4 allergic or anaphylactic reaction to naxitamab, leading to the discontinuation of naxitamab during prior therapy.
Lab requirements
Blood counts
Hematological recovery as defined by absolute neutrophil count (ANC) ≥750/μL, platelets ≥30/μL (may be transfused).
Kidney function
Creatinine clearance (in units ml/min) or radioisotope GFR ≥ 70. The formula to be used: Adjusted Glomerular Filtration Rate (GFR)=(Estimated GFR×BSA/1.73) mL/min.
Liver function
Normal liver function as defined by Aspartate transferase (AST), Alanine transaminase (ALT), and total bilirubin (TBL) all within upper limit of normal
Cardiac function
QTcF ≤ 470 msc.
Subjects must have adequate organ function at the time of enrollment: 1. Hematological: Hematological recovery as defined by absolute neutrophil count (ANC) ≥750/μL, platelets ≥30/μL (may be transfused). 2. Liver: Normal liver function as defined by Aspartate transferase (AST), Alanine transaminase (ALT), and total bilirubin (TBL) all within upper limit of normal 3. Renal: Subjects must have adequate renal function defined as Creatinine clearance (in units ml/min) or radioisotope GFR ≥ 70. The formula to be used: Adjusted Glomerular Filtration Rate (GFR)=(Estimated GFR×BSA/1.73) mL/min. 4. Cardiac: Subjects must have a QTcF ≤ 470 msc.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arkansas Children's Hospital · Little Rock, Arkansas
- Connecticut Children's Hospital · Hartford, Connecticut
- Nicklaus Children's Hospital · Miami, Florida
- Arnold Palmer Hospital for Children · Orlando, Florida
- Kapiolani Medical Center for Women and Children · Honolulu, Hawaii
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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