Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

Conditions

• Refractory Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trifluridine/Tipiracil — DRUG
  Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
• Bevacizumab — DRUG
  administered every 2 weeks (Day 1 and Day 15)

Study Details

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Key Dates

First listed

Feb 3, 2021

Start date

Nov 25, 2020

Status verified

Aug 2024

Primary completion

Jul 19, 2022

Completion

Sep 12, 2023

Study Design

Enrollment

492 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Trifluridine/Tipiracil + Bevacizumab
  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.
• Active Comparator: Trifluridine/Tipiracil
  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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months) ]

Locations (12)

Find similar trials in Phoenix, AZ

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