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

You may not qualify if:

• 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)
• 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
• Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL
• Treated or localized well-differentiated thyroid cancer
• Treated cervical carcinoma in situ
• Treated ductal/lobular carcinoma in situ of the breast
• Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of investigational product. Participants with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at screening.
• Participants with poor-controlled arterial hypertension (systolic blood pressure \> 140 mmHg and diastolic blood pressure \> 90 mmHg) despite standard medical management
• Participants with Grade II or greater myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (QTc interval ≥ 450 ms in males and ≥ 470 ms in females);
• Participants with NYHA (see Appendix 5) Class III-IV cardiac insufficiency or LVEF (left ventricular ejection fraction) \< 50% by echocardiography;
• +4 more criteria