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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 years 1 and 2

Awards & highlights

Study Summary

This trial will test the safety and efficacy of rivoceranib in people with ACC that has progressed or spread. People will remain on treatment until disease progression, toxicity, death, withdrawal of consent, or the study ends. There is a follow-up period of 24 months after treatment.

Eligible Conditions

Adenoid Cystic Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ years 1 and 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~years 1 and 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and years 1 and 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR): Percentage of Participants who Achieve Confirmed Complete Response (CR) or Partial Response (PR)

Secondary outcome measures

Duration of Response (DoR)

Number of Participants With Adverse Events (AEs)

Overall Survival (OS) at 1 Year and 2 Years

+2 more

Other outcome measures

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%

Weight decreased

22%

Stomatitis

21%

Anaemia

21%

Alanine aminotransferase increased

17%

Vomiting

17%

Constipation

15%

Platelet count decreased

14%

Dysphonia

14%

Blood alkaline phosphatase increased

13%

Headache

12%

Pyrexia

12%

Blood bilirubin increased

11%

Hypoalbuminaemia

Abdominal pain upper

Dyspepsia

Back pain

Oedema peripheral

Insomnia

Rash

Ascites

Dyspnoea

Pneumonia

Ileus

Bile duct obstruction

Obstruction gastric

Acute kidney injury

Upper gastrointestinal haemorrhage

Posterior reversible encephalopathy syndrome

Hyperbilirubinaemia

Pleural effusion

Jaundice cholestatic

Gastric haemorrhage

Dysphagia

General physical health deterioration

Cholangitis

Hepatic failure

Biliary dilatation

Cholecystitis

Biliary sepsis

Gastrointestinal haemorrhage

Hepatic function abnormal

Small intestinal obstruction

Lipase increased

Pancreatitis

Gastric perforation

Large intestine perforation

Tumour haemorrhage

100%

80%

60%

40%

20%

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

2019

Completed Phase 3

~630

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are actively conducting this medical trial?

"This trial is being held at the University of California San Francisco, The University of Colorado Denver and Dana-Farber Cancer Institute - Head and Neck Oncology. Additionally there are 8 other participating sites spread across the nation."

Answered by AI

Has Rivoceranib been given the final seal of approval by the FDA?

"Rivoceranib's safety was estimated at a score of 2, as it is currently in Phase 2 clinical trials and there has been some data collected on its safety but not efficacy."

Answered by AI

To what extent has recruitment been achieved for this trial?

"This study is no longer receiving patient applications. It appeared on 3/4/2020 and was last updated in April of 2022. For those seeking alternative trials, there are currently 2470 studies recruiting carcinoma patients and 95 for Rivoceranib that remain open to applicants."

Answered by AI

What other investigations have been conducted regarding Rivoceranib?

"Currently, there are 95 research projects actively investigating Rivoceranib. Of those studies, 14 have advanced to Phase 3 trials and span 128 sites around the world, including Shijiazhuang in Hebei Province."

Answered by AI

Are there any slots available for individuals to join this experiment?

"Participants are no longer being accepted into this clinical trial, which was initially published on March fourth 2020 and modified lastly on April first 2022. Prospective applicants seeking comparable studies may explore 2,470 trials actively recruiting patients with carcinoma or adenoid cystic as well as 95 trials for Rivoceranib that require participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)

2020. "A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04119453.