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Tyrosine Kinase Inhibitor
A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)
Phase 1
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 up to approximately 3 years
Awards & highlights
No Placebo-Only Group
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 ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
(Phase 1b and Phase 2) Overall Survival (OS)
(Phase 2) Disease Control Rate (DCR)
(Phase 2) Objective Response Rate (ORR)
+2 moreOther study objectives
(Phase 1b) AUC
(Phase 1b) CL
(Phase 1b) Cmax
+3 moreSide effects data
From 2020 Phase 3 trial • 460 Patients • NCT0304261143%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2021
Completed Phase 3
~520
Trifluridine/Tipiracil
2019
Completed Phase 3
~760
Find a Location
Who is running the clinical trial?
Elevar TherapeuticsLead Sponsor
8 Previous Clinical Trials
702 Total Patients Enrolled
Steven Norton, PhDStudy DirectorElevar Therapeutics, Inc.
2 Previous Clinical Trials
110 Total Patients Enrolled