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Tyrosine Kinase Inhibitor

Rivoceranib for Adenoid Cystic Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Elevar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will complete (fact)-g questionnaire every 8 weeks for the first year of therapy, then every 12 weeks thereafter and at end of treatment (eot), assessed up to approximately 24 months after last patient enro
Awards & highlights

Summary

This trial is testing rivoceranib, a medication, in adults whose ACC cancer has come back or spread. Rivoceranib aims to block signals that help cancer cells grow. Participants will stay on the treatment as long as it is effective and tolerable.

Eligible Conditions
  • Adenoid Cystic Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will complete (fact)-g questionnaire every 8 weeks for the first year of therapy, then every 12 weeks thereafter and at end of treatment (eot), assessed up to approximately 24 months after last patient enro
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will complete (fact)-g questionnaire every 8 weeks for the first year of therapy, then every 12 weeks thereafter and at end of treatment (eot), assessed up to approximately 24 months after last patient enro for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)
Secondary study objectives
Duration of Response (DoR)
Progression free survival (PFS) at 6 Months, 12 Months, and 2 Years
Time to progression (TTP)
Other study objectives
Evaluate Disease control rate (DCR) of rivoceranib
Evaluate quality of life measurements during treatment with rivoceranib
Evaluate the pharmacokinetics (PK) of rivoceranib: AUC
+5 more

Side effects data

From 2020 Phase 3 trial • 460 Patients • NCT03042611
43%
Decreased appetite
35%
Hypertension
30%
Diarrhoea
29%
Proteinuria
27%
Asthenia
26%
Palmar-plantar erythrodysaesthesia syndrome
25%
Abdominal pain
25%
Fatigue
23%
Nausea
23%
Aspartate aminotransferase increased
22%
Stomatitis
22%
Weight decreased
21%
Alanine aminotransferase increased
21%
Anaemia
17%
Vomiting
17%
Constipation
15%
Platelet count decreased
14%
Blood alkaline phosphatase increased
14%
Dysphonia
13%
Headache
12%
Pyrexia
12%
Blood bilirubin increased
11%
Hypoalbuminaemia
9%
Abdominal pain upper
8%
Dyspepsia
6%
Oedema peripheral
6%
Rash
6%
Back pain
6%
Insomnia
5%
Ascites
5%
Dyspnoea
3%
Pneumonia
2%
Ileus
2%
Bile duct obstruction
1%
Biliary dilatation
1%
Hepatic failure
1%
Biliary sepsis
1%
Jaundice cholestatic
1%
Hyperbilirubinaemia
1%
Gastric haemorrhage
1%
Dysphagia
1%
Upper gastrointestinal haemorrhage
1%
Gastrointestinal haemorrhage
1%
Obstruction gastric
1%
Small intestinal obstruction
1%
General physical health deterioration
1%
Cholangitis
1%
Pleural effusion
1%
Hepatic function abnormal
1%
Cholecystitis
1%
Posterior reversible encephalopathy syndrome
1%
Acute kidney injury
1%
Lipase increased
1%
Pancreatitis
1%
Gastric perforation
1%
Large intestine perforation
1%
Tumour haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rivoceranib Plus Best Supportive Care (BSC)
Placebo Plus BSC

Trial Design

1Treatment groups
Experimental Treatment
Group I: RivoceranibExperimental Treatment1 Intervention
Participants will receive an oral dose of rivoceranib once per day during 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivoceranib
2021
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

Elevar TherapeuticsLead Sponsor
8 Previous Clinical Trials
667 Total Patients Enrolled
Steven Norton, PhDStudy DirectorElevar Therapeutics,inc
2 Previous Clinical Trials
59 Total Patients Enrolled
~14 spots leftby Sep 2025
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