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Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1

NCT ID: NCT02243150

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-18

Brief Summary

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This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

6mg/m2 of G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2

Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 1; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 3

Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 2; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 4

Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 3; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 5

Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 4; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 6

Dose of G1T28-1 or placebo will be determined based on the safety and PK data from Cohort 5; G1T28-1 or placebo will be administered in 50mL of 5% dextrose by IV infusion. Subjects from this cohort may be selected to participate in the Whole Blood Ex-Vivo Stimulation group.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 7 - Bone Marrow Cohort

All subjects in this cohort will receive active drug, G1T28-1. Dose of G1T28-1 will be determined based on the safety and PK data from previous cohorts. G1T28-1 will be administered in 50mL of 5% dextrose by IV infusion. Subjects in this cohort will be selected for the Ex-Vivo Stimulation group and will have a one time bone marrow aspirate at one of the following time points: pre dose, 12 or 24 hours post dose.

Group Type EXPERIMENTAL

G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Interventions

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G1T28-1 (CDK 4/6 Inhibitor)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers, 18-60 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
* Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg
* Non-smokers / non-users of nicotine containing products for at least the previous 3 months
* Agreement to use birth control during the study and 3 months post last visit
* Able to comply with all protocol requirements and procedures

Exclusion Criteria

* Clinically significant abnormalities found during physical examination, medical history review, ECGs (including QTcf interval \> 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C)
* History of any serious allergic reaction to any medication
* Participated in a previous clinical trial with an investigational product in the last 60 days
* Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
* History of drug or alcohol abuse in the last 2 years and positive test for drug abuse
* Use of any systemic medication within the past 2 weeks, including use of herbal products
* Pregnant or lactating women
* Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G1 Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renger Tiessen, MD

Role: PRINCIPAL_INVESTIGATOR

PRA Clinic Netherlands

Locations

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PRA Early Development Clinic

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

Reference Type DERIVED
PMID: 33595690 (View on PubMed)

Other Identifiers

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G1T28-1-01

Identifier Type: -

Identifier Source: org_study_id