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CDK 4/6 Inhibitor
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): (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 up to 52 months
Awards & highlights
Pivotal 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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of Severe Neutropenia (DSN)
Occurrence of Severe Neutropenia (SN) During Induction
Secondary study objectives
Additional Myelopreservation Measures
Best Overall Response (BOR)
Duration of Objective Response (DOR)
+10 moreSide effects data
From 2019 Phase 1 & 2 trial • 122 Patients • NCT0249977058%
Fatigue
42%
Neutropenia
42%
Anemia
42%
Leukopenia
42%
Nausea
42%
Alopecia
33%
Vomiting
33%
Headache
33%
Constipation
25%
Thrombocytopenia
25%
Pyrexia
25%
Diarrhea
17%
Dizziness
17%
Arthralgia
17%
Dyspnea
17%
Chills
17%
Edema peripheral
17%
Insomnia
8%
Bone pain
8%
Neck pain
8%
Cough
8%
Hyperglycemia
8%
Pneumonia
8%
Myocardial infarction
8%
Blood creatinine increased
8%
Infusion related reaction
8%
Weight decreased
8%
Asthenia
8%
Anxiety
8%
Night sweats
8%
Back pain
8%
Dehydration
8%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Part 2: Placebo
Part 2: Trilaciclib 240 mg/m^2
Part 1: Cohort 2 Trilaciclib 240mg/m^2
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 46 to 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 at study entry. 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
~400
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