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Metastatic Olfactory NeuroblastomaPhase 2NCT06308575

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

A Phase 2 study testing Rivoceranib in people with Metastatic Olfactory Neuroblastoma and Recurrent Olfactory Neuroblastoma, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Rivoceranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Nov 2024to 5 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria b) Absolute neutrophil count ≥ 1 x 109
  • mL c) Platelets ≥ 80 x 109
  • mL
  • Laboratory measurements, renal function:
  • 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.

Who cannot join

  • 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.:
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  • 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;
  • Presence of multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug administration and absorption);
  • Urine protein ≥ ++ or 24 h urine protein > 1.0 g as indicated by urinalysis
  • Female subjects who are pregnant or breast-feeding
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

About this study

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

Read the detailed description

Primary Objective:

  • To assess the efficacy of rivoceranib in patients with R/M ONB

Secondary Objective:

  • To estimate the median duration of response (DOR)
  • Time to response
  • To estimate the median progression-free survival (PFS)
  • To estimate the median overall survival (OS)
  • To assess safety of rivoceranib

Tertiary Objective:

  • To explore biomarkers that may predict response to therapy
Being tested
Rivoceranib
Medical subject headings
Esthesioneuroblastoma, Olfactory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivoceranibDrug

    Given by PO

Study groups in NCT06308575
Study groupRoleWhat they receive
RivoceranibExperimentalParticpants will take rivoceranib by mouth 1 time each day while on study.
Receives: Drug: Rivoceranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start1 Nov 2024
  3. Primary completion5 Nov 2024
  4. Study completion5 Nov 2024

Why it stopped: PI Request--No Patient Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308575
Sponsor's protocol ID
2023-0771
Other IDs
NCI-2024-02155
Status last verified
Jan 2025
First submitted
7 Mar 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivoceranib in people with Metastatic Olfactory Neuroblastoma and Recurrent Olfactory Neuroblastoma, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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