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Monoclonal Antibodies

Trifluridine/Tipiracil for Colorectal Cancer (SUNLIGHT Trial)

Phase 3
Waitlist Available
Led By Josep Tabernero, Prof
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Other clinically significant medical conditions.
Other malignancies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until 3, 6, 9, and 12 months post treatment
Awards & highlights

SUNLIGHT Trial Summary

This trial will compare the efficacy and safety of a combination of drugs versus one of the drugs alone in patients with a certain type of cancer that has not responded to other treatments.

Eligible Conditions
  • Colorectal Cancer

SUNLIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have other important medical problems.
Select...
You have another type of cancer.
Select...
You can swallow pills.

SUNLIGHT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until 3, 6, 9, and 12 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until 3, 6, 9, and 12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Survival Probability at 12 Months
Survival Probability at 18 Months
+1 more
Secondary outcome measures
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)
Overall Response Rate (ORR)
Percentage of Participants With Disease Control
+2 more

Side effects data

From 2023 Phase 3 trial • 492 Patients • NCT04737187
62%
Neutropenia
37%
Nausea
28%
Anaemia
24%
Asthenia
22%
Fatigue
21%
Diarrhoea
20%
Decreased appetite
18%
Vomiting
17%
Thrombocytopenia
14%
Neutrophil count decreased
11%
Abdominal pain
11%
Stomatitis
11%
Constipation
10%
Hypertension
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
8%
Weight decreased
8%
Headache
7%
Leukopenia
7%
Arthralgia
7%
Back pain
6%
Proteinuria
5%
Blood bilirubin increased
5%
Pyrexia
3%
Intestinal obstruction
2%
COVID-19
2%
Malignant neoplasm progression
1%
Biliary dilatation
1%
Jaundice
1%
Metastases to meninges
1%
Stoma site haemorrhage
1%
Large intestinal obstruction
1%
Jaundice cholestatic
1%
Hyperbilirubinaemia
1%
Acute kidney injury
1%
Bile duct stenosis
1%
Cholangitis
1%
Septic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifluridine/Tipiracil + Bevacizumab
Trifluridine/Tipiracil

SUNLIGHT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trifluridine/Tipiracil + BevacizumabExperimental Treatment2 Interventions
Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram [mg/kg], intravenous [IV] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
Group II: Trifluridine/TipiracilActive Control1 Intervention
Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifluridine/Tipiracil
2019
Completed Phase 3
~790
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,071 Total Patients Enrolled
Institut de Recherches Internationales ServierOTHER
86 Previous Clinical Trials
69,069 Total Patients Enrolled
Josep Tabernero, ProfPrincipal InvestigatorVall d'Hebron Institute of Oncology

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04737187 — Phase 3
Colorectal Cancer Research Study Groups: Trifluridine/Tipiracil, Trifluridine/Tipiracil + Bevacizumab
Colorectal Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04737187 — Phase 3
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04737187 — Phase 3

Frequently Asked Questions

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

Is Trifluridine/Tipiracil a new or experimental medication?

"As of right now, 411 clinical trials are underway for Trifluridine/Tipiracil. Of these active studies, 103 have progressed to Phase 3 testing. The large majority of the related studies are based in Taibei, Taiwan but there are 19423 locations worldwide running similar investigations."

Answered by AI

Across how many hospitals is this research being conducted?

"In addition to UT Southwestern, Dana Farber Cancer Institute, and Tennessee Oncology, this clinical trial is also being conducted at 23 other locations."

Answered by AI

What are the most common indications for Trifluridine/Tipiracil?

"Trifluridine/Tipiracil, which is commonly used to treat recurrent platinum-resistant epithelial ovarian cancer, can also be useful for treating other conditions such as previously treated with oxaliplatin chemotherapy, malignant neoplasms, and recurrent platinum sensitive primary peritoneal cancer."

Answered by AI

How many people can safely participate in this experiment?

"This clinical trial is not presently seeking patients at this time. The trial was first posted on 11/25/2020 and was last edited on 4/4/2022. If you are exploring for other studies, there are presently 896 clinical trials actively admitting patients with colorectal cancer and 411 studies for Trifluridine/Tipiracil actively recruiting patients."

Answered by AI

What is the FDA's opinion on Trifluridine/Tipiracil?

"Trifluridine/Tipiracil has been studied in Phase 3 trials, which means that while there is evidence of efficacy, more data is needed to support safety."

Answered by AI

Are there any current openings for patients who want to participate in this research?

"This study, which was most recently updated on April 4th, 2022 is not currently looking for new participants. This according to the data available on clinicaltrials.gov. Out of the 1,307 other trials that are recruiting patients at this time, this one is not."

Answered by AI
~114 spots leftby Mar 2025