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

NCT06308575 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0771NCI-2024-02155
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metastatic Olfactory Neuroblastoma; Recurrent Olfactory Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Rivoceranib

EXPERIMENTAL

Particpants will take rivoceranib by mouth 1 time each day while on study.

Drug: Rivoceranib

Interventions

Rivoceranib DRUG

Given by PO

Rivoceranib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mL c) Platelets ≥ 80 x 109
• Laboratory measurements, renal function:
• a) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
• Laboratory measurements, hepatic function:
• AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in subjects with liver metastases
• Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if subject has a documented history of Gilbert's syndrome or genetic equivalent
• Female participants with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
• Male participants who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy.

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;

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Elevar Therapeutics: collaborator

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Esthesioneuroblastoma, Olfactory

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Luana Guimaraes De Sousa, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: November 1, 2024
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01