OncoMatch/Clinical Trials/NCT06540963
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Is NCT06540963 recruiting? Yes, currently enrolling (Sep 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 participants with cancer * To determine the activity of study treatments chosen based on: * How each participant responds to the study treatment * How long a participant lives without their disease returning/progressing
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification
Demographics
Prior therapy
Must have received: multi-drug induction chemotherapy
at least 4 cycles of aggressive multi-drug induction chemotherapy
Cannot have received: investigational drug
Participants who are currently receiving another investigational drug are excluded from participation.
Cannot have received: anticancer agent
Participants who are currently receiving other anticancer agents are not eligible.
Cannot have received: naxitamab (naxitamab)
Previous Gr.4 allergic or anaphylactic reaction to naxitamab, leading to the discontinuation of naxitamab during prior therapy.
Lab requirements
Blood counts
ANC ≥750/μL, platelets ≥30/μL (may be transfused)
Kidney function
eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz equation for <17 years, Cockcroft and Gault for ≥17 years)
Liver function
Normal liver function as defined by AST, ALT, and total bilirubin all within upper limit of normal
Cardiac function
QTcF ≤ 470 msc
Participants must have adequate organ function at the time of enrollment: Hematological: Hematological recovery as defined by absolute neutrophil count (ANC) ≥750/μL, platelets ≥30/μL (may be transfused). Liver: Normal liver function as defined by AST, ALT, and total bilirubin all within upper limit of normal. Renal: eGFR ≥ 70 mL/min/1.73 m2. Cardiac: 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 →Frequently asked questions
Is NCT06540963 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, anticancer agent, naxitamab disqualifies patients from enrollment.
Does this trial require MYCN?
Yes, MYCN amplification is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages