WithdrawnPhase 2

A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma

Stopped: PI Request--No Patient Accrual

0Started 2024-11-01

Plain-language summary

To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participants ≥18 years with histology-proven R/M ONB.
✓. Not amenable to curative intent surgery or radiotherapy
✓. Measurable disease per RECIST 1.1
✓. Performance status ECOG of 0 or 1
✓. VEGFR-inhibitor naïve (R/M ONB never treated with VEGFR inhibitors)
✓. Laboratory measurements, blood counts:
✓. Laboratory measurements, renal function:
✓. Laboratory measurements, hepatic function:

Exclusion criteria

✕. Prior radiation therapy (or other nonsystemic therapy) within 2 weeks prior to enrollment
✕. Active CNS disease (participants with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)
✕. Red blood cell transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criterion.
✕. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to rivoceranib treatment
✕. Current participation in another interventional clinical study
✕. History of previous malignancy other than malignancy treated with curative intent within less than 5 years. Participants with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug.:
✕. Non-melanoma skin cancers with no current evidence of disease
✕. Melanoma in situ with no current evidence of disease

What they're measuring

Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT06308575

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-05

View on ClinicalTrials.gov More Metastatic Olfactory Neuroblastoma trials