Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients (SUNLIGHT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04737187 |
Recruitment Status :
Completed
First Posted : February 3, 2021
Results First Posted : December 26, 2023
Last Update Posted : December 26, 2023
|
Sponsor:
Taiho Oncology, Inc.
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
Taiho Oncology, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Refractory Metastatic Colorectal Cancer |
Interventions |
Drug: Trifluridine/Tipiracil Drug: Bevacizumab |
Enrollment | 492 |
Participant Flow
Recruitment Details | The study was conducted at 99 active sites in 13 countries. A total of 659 participants were screened, of which 492 participants were randomized and treated. |
Pre-assignment Details | Participants were randomized to 2 treatment arms in 1:1 ratio by interactive web response system stratified by geographic region (North America, European Union, Rest of the World), time since first metastasis diagnosis (less than [<] 18 months, greater than or equal to [>=] 18 months) and rat sarcoma virus (RAS) status (wild-type, mutant). Data reported based on primary completion date, i.e., 19 July 2022. |
Arm/Group Title | Trifluridine/Tipiracil + Bevacizumab | Trifluridine/Tipiracil |
---|---|---|
Arm/Group Description | 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 and 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. | 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. |
Period Title: Overall Study | ||
Started | 246 | 246 |
Completed | 0 | 0 |
Not Completed | 246 | 246 |
Reason Not Completed | ||
Continuing the study on treatment | 32 | 4 |
Radiological Progressive Disease | 145 | 146 |
Clinical Progressive Disease | 20 | 20 |
Radiological And Clinical Progressive Disease | 26 | 52 |
Adverse Event | 16 | 16 |
Physician Decision | 2 | 0 |
Withdrawal by Subject | 5 | 8 |
Baseline Characteristics
Arm/Group Title | Trifluridine/Tipiracil + Bevacizumab | Trifluridine/Tipiracil | Total | |
---|---|---|---|---|
Arm/Group Description | Participants were administered 35 mg/m²/dose 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; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 246 | 246 | 492 | |
Baseline Analysis Population Description |
Full Analysis Set (FAS): all participants to whom a therapeutic unit was randomly assigned using Interactive Web Response System (IWRS). Participants were analyzed in the arm they were assigned by randomization.
|
|||
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
Number Analyzed | 246 participants | 246 participants | 492 participants | |
62.00
(20.0 to 84.0)
|
64.00
(24.0 to 90.0)
|
63.00
(20.0 to 90.0)
|
||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 246 participants | 246 participants | 492 participants |
Adults (18-64 years) |
146 59.3%
|
129 52.4%
|
275 55.9%
|
|
From 65-84 years |
100 40.7%
|
116 47.2%
|
216 43.9%
|
|
85 years and over |
0 0.0%
|
1 0.4%
|
1 0.2%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 246 participants | 246 participants | 492 participants | |
Female |
124 50.4%
|
112 45.5%
|
236 48.0%
|
|
Male |
122 49.6%
|
134 54.5%
|
256 52.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 246 participants | 246 participants | 492 participants | |
American Indian or Alaska Native |
1 0.4%
|
0 0.0%
|
1 0.2%
|
|
Asian |
0 0.0%
|
1 0.4%
|
1 0.2%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
4 1.6%
|
3 1.2%
|
7 1.4%
|
|
White |
215 87.4%
|
220 89.4%
|
435 88.4%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
26 10.6%
|
22 8.9%
|
48 9.8%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Taiho |
Organization: | Taiho Oncology, Inc. |
Phone: | 1-609-250-7336 |
EMail: | clinicaltrialinfo@taihooncology.com |
Responsible Party: | Taiho Oncology, Inc. |
ClinicalTrials.gov Identifier: | NCT04737187 |
Other Study ID Numbers: |
CL3-95005-007 2020-001976-14 ( EudraCT Number ) |
First Submitted: | January 29, 2021 |
First Posted: | February 3, 2021 |
Results First Submitted: | October 17, 2023 |
Results First Posted: | December 26, 2023 |
Last Update Posted: | December 26, 2023 |