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CDK 4/6 Inhibitor

Trilaciclib for Colorectal Cancer (PRESERVE1 Trial)

Phase 3
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
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 through induction period- on average 24 weeks (up to 12 cycles) of folfoxiri/bevacizumab
Awards & highlights

PRESERVE1 Trial Summary

This trial is testing the effects of a new drug on patients with a certain type of cancer who have not yet received treatment.

Eligible Conditions
  • Metastatic Colorectal Cancer
  • Myelosuppression
  • Chemotherapy Toxicity

PRESERVE1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until date of death due to any cause
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of death due to any cause for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Myelopreservation
Secondary outcome measures
Anti-tumor Efficacy
Quality of Life/ Effects on Chemotherapy-Induced Fatigue

Side effects data

From 2019 Phase 1 & 2 trial • 122 Patients • NCT02499770
42%
Fatigue
34%
Nausea
26%
Thrombocytopenia
26%
Anemia
24%
Neutropenia
24%
Constipation
21%
Dyspnea
18%
Headache
18%
Abdominal pain upper
18%
Decreased appetite
16%
Alopecia
16%
Diarrhea
13%
Cough
13%
Arthralgia
11%
Dizziness
8%
Neutrophil count decreased
8%
Platelet count decreased
8%
Anxiety
8%
Vomiting
8%
Hyperkalemia
8%
Pain in extremity
8%
Infusion related reaction
8%
Oropharyngeal pain
8%
Dysgeusia
8%
Edema peripheral
8%
Non-cardiac chest pain
8%
Night sweats
5%
Leukopenia
5%
Weight decreased
5%
Respiratory failure
5%
Urinary tract infection
5%
Pneumonia
5%
Hyperglycemia
5%
Gastroesophageal reflux disease
5%
Blood creatinine increased
5%
Neuropathy peripheral
5%
Stomatitis
5%
Back pain
5%
Hypomagnesemia
3%
Pancreatitis
3%
Insomnia
3%
Chills
3%
Upper respiratory tract infection
3%
Influenza
3%
Febrile neutropenia
3%
Hemoptysis
3%
Pulmonary embolism
3%
Cerebrovascular accident
3%
Epilepsy
3%
Syncope
3%
Diarrhea hemorrhagic
3%
Renal failure
3%
Pyrexia
3%
Neck pain
3%
Asthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Trilaciclib 240 mg/m^2
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Part 2: Placebo
Part 1: Cohort 2 Trilaciclib 240mg/m^2

PRESERVE1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: trilaciclib + FOLFOXIRI/bevacizumabExperimental Treatment1 Intervention
During Induction the following study drugs are administered on Day 1: Irinotecan- IV Oxaliplatin - IV Leucovorin- IV Fluorouracil - continuous infusion (CI) over 48 hours beginning on Day 1; Bevacizumab - IV Following completion of Induction, patients will continue in Maintenance, where they will continue to receive trilaciclib per randomization allocation. Trilaciclib will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.
Group II: placebo + FOLFOXIRI/bevacizumabPlacebo Group1 Intervention
The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
2015
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
2,965 Total Patients Enrolled
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
989 Total Patients Enrolled

Frequently Asked Questions

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

What is Trilaciclib used to treat?

"Trilaciclib can be used as a therapy for treating malignant neoplasms, bone marrow, and related procedures."

Answered by AI

What does the scientific literature say about Trilaciclib's efficacy?

"8 studies are currently underway to assess the efficacy of Trilaciclib. Of these, 3 are Phase 3 clinical trials. However, because there are 408 total study locations, it is likely that one is near you."

Answered by AI

Has Trilaciclib received government recognition in the United States?

"Our analysts have determined that Trilaciclib is safe enough to receive a 3 on our 1-to-3 scale. This is due to the fact that this is a Phase 3 trial, so there exists some evidence of efficacy in addition to multiple rounds of data affirming its safety."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Beverly Hills Cancer Center
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Beverly Hills Cancer Center: < 48 hours
Average response time
  • < 2 Days
~74 spots leftby Mar 2025