G1T28-207-Trilaciclib vs placebo in patients receiving FOLFOXIRI/bevac
Research type
Research Study
Full title
PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
IRAS ID
287617
Contact name
Robert Jones
Contact email
Sponsor organisation
G1 Therapeutics, Inc.
Eudract number
2019-003826-25
Clinicaltrials.gov Identifier
119254, IND
Duration of Study in the UK
3 years, 11 months, 17 days
Research summary
Summary of Research:
This is a global, Phase 3 trial where participants with a certain type of metastatic colorectal cancer called “proficient mismatch repair/microsatellite stable” (pMMR/MSS) will be randomly (like flipping a coin) assigned to one of the following treatment groups:
- Trilaciclib (study drug) prior to chemotherapy (FOLFOXIRI/bevacizumab)
- Placebo (inactive medication) prior to chemotherapy (FOLFOXIRI/bevacizumab)Neither the participant nor the doctor will know which group each participant has been assigned to.
The main purpose of the study is to test whether trilaciclib can protect the bone marrow (where the cells used to fight infection, carry oxygen and clot blood are made) from damage by chemotherapy. The study will also test whether patients receiving trilaciclib feel less tired during chemotherapy and how long the chemotherapy keeps the colorectal cancer under control in patients receiving trilaciclib compared with those who do not receive trilaciclib.
The study consists of three periods:
- screening period to assess if participants are eligible for the study. This period can last up to 4 weeks
- treatment period. The treatment period is split into 2 parts: Induction and Maintenance.
a)Induction: to receive placebo or trilaciclib on Days 1 and 2 administered intravenously (drip into a vein) prior to FOLFOXIRI/bevacizumab in 14-day cycles for up to 12 cycles
b)Maintenance: If Induction was completed without cancer worsening, participants will enter Maintenance. Participants will continue to receive the study drug or placebo (as assigned at the start of the treatment period) with leucovorin/ fluorouracil/bevacizumab.
Treatment in both Induction and Maintenance will continue until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first.
- survival follow-up periodApproximately 296 participants will take part in this study from around 99 centres globally.
Research Summary:
The primary goal of this study was to see if trilaciclib could help decrease the occurrence of severe neutropenia (SN). Severe neutropenia is when there is a large decrease in the number of neutrophils, a type of white blood cell that helps you fight infections. In addition, the study wanted to determine if the duration of severe neutropenia (DSN), when it did occur, was shorter after receiving trilaciclib.
The results of the study showed that fewer patients had SN after trilaciclib treatment (1.34%) compared with patients treated with placebo (19.7%), and that when SN occurred, its duration was shorter following trilaciclib treatment (0.1 days) compared with placebo (1.3 days).
Analysis of tumor responses to treatment (tumor shrinkage or disappearance) and early analysis of survival favored placebo.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0166
Date of REC Opinion
8 Dec 2020
REC opinion
Further Information Favourable Opinion