← Back to Search

Tyrosine Kinase Inhibitor

Rivoceranib for Colorectal Cancer

Phase 1 & 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 baseline up to 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, rivoceranib, to see if it can help people with metastatic colorectal cancer live longer without the cancer progressing.

Eligible Conditions

Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

(Phase 1b) Number of Participants with Adverse Events (AEs)investigator assessment

(Phase 1b) Number of Participants with Serious Adverse Events (SAEs)

(Phase 1b) Percentage of Participants with Dose-limiting Toxicity (DLT) During Cycle 1

+1 more

Secondary outcome measures

(Phase 1b and 2) Number of Participants with Adverse Events (AEs) that Worsen in Severity as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

(Phase 1b and Phase 2) Overall Survival (OS)

(Phase 2) Disease Control Rate (DCR)

+3 more

Other outcome measures

(Phase 1b) AUC

(Phase 1b) CL

(Phase 1b) Cmax

+3 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

Oedema peripheral

Back pain

Insomnia

Rash

Ascites

Dyspnoea

Pneumonia

Ileus

Bile duct obstruction

Acute kidney injury

Obstruction gastric

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

3Treatment groups

Experimental Treatment

Active Control

Group I: Rivoceranib and trifluridine/tipiracilExperimental Treatment2 Interventions

Participants will receive a daily oral dose of rivoceranib on Days 1 through 28 and the recommended phase 2 dose (RP2D) of trifluridine/tipiracil twice per day between Days 1 to 5 and 8 to 12 of each 28-day cycle.

Group II: RivoceranibExperimental Treatment1 Intervention

Participants will receive an oral dose of rivoceranib once per day on Days 1 through 28 of each 28-day cycle.

Group III: Trifluridine/tipiracilActive Control1 Intervention

Participants will receive an oral dose of Trifluridine/tipiracil twice per day with food, on Days 1 through 5 and Days 8 through 12 of each 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rivoceranib

2019

Completed Phase 3

~630

Trifluridine/Tipiracil

2019

Completed Phase 3

~790

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Elevar TherapeuticsLead Sponsor

8 Previous Clinical Trials

718 Total Patients Enrolled

Steven Norton, PhDStudy DirectorElevar Therapeutics, Inc.

2 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

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

Are there any similar experiments that have been undertaken with Rivoceranib?

"As of right now, there are a total of 136 clinical trials studying Rivoceranib with 20 being in Phase 3. Most of these research studies are based in Shijiazhuang, Hebei; however, there are 773 locations globally running clinical trials for Rivoceranib."

Answered by AI

In how many different geographical areas is this trial taking place?

"The clinical trial is currently taking place at Florida Cancer Specialists in Sarasota, Washington University School of Medicine in Saint Louis, Northwestern University in Chicago, and 4 other locations."

Answered by AI

What is the primary indication for Rivoceranib?

"Rivoceranib is most often used to treat vaccinia infection of the cornea and conjunctiva. Additionally, it can be an effective medication for patients who have previously been treated with oxaliplatin chemotherapy or anti-vegf therapy, as well as those suffering from blepharitis."

Answered by AI

Are people currently being signed up for this research project?

"This particular trial, as clinicaltrials.gov reflects, is not currently looking for new patients to participate. The listing was created on 18th November 2019 and updated for the last time on the 18th of May in 2022. Even though this study isn't recruiting, there are 1056 other trials which are actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)

2019. "A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073615.