Carcinoma, Ductal, BreastPhase 1/2NCT02983071
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Phase 1/2 study testing G1T38 and Fulvestrant in people with Carcinoma, Ductal, Breast and Breast Cancer, run by G1 Therapeutics, Inc. at 8 sites in 4 countries.
Trial summary
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- What is being tested?
- G1T38 and Fulvestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 2017to Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
- Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin
- Patients must satisfy 1 of the following criteria for prior therapy:
- Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor or tamoxifen
- Progressed during treatment or within 2 months after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer, or prior endocrine therapy for advanced/metastatic breast cancer
- Received ≤ 2 chemotherapy regimens (Part 1) or ≤ 1 chemotherapy regimen (Part 2) for advanced/metastatic disease
Show all 10Show fewer
- For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
- For Part 2, measurable disease as defined by RECIST, Version 1.1
- ECOG performance status 0 to 1
- Adequate organ function
Who cannot join
- For Part 1, prior treatment with fulvestrant
- For Part 2, prior treatment with any CDK inhibitor or fulvestrant
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Chemotherapy within 21 days of first G1T38 dose
- Investigational drug within 28 days of first G1T38 dose
- Concurrent radiotherapy, radiotherapy within 14 days of first G1T38 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
- Prior hematopoietic stem cell or bone marrow transplantation
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom4 sites
Cambridge University
Cambridge, CB2 0QQ
University College London Hospital (UCLH)
London, NW1 2BU
Sarah Cannon Research Institute
London, W1G 6AD
The Christie NHS Foundation
Manchester, M20 4BX
Bulgaria2 sites
MHAT for Womens Health - Nadezhda OOD
Sofia, 1330
Special Hospital For Active Treatment In Oncology
Sofia, 1756
About this study
Official title: Phase 1/2 Safety, Pharmacokinetic, and Antitumor Activity Study of G1T38 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer After Endocrine Failure
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- Being tested
- G1T38, Fulvestrant
- Keywords
- Breast Cancer, CDK 4/6 Inhibitor, HER2-Negative, HR-Positive, HR+, HER2-, HER2 -ve, HER2 +ve
- Medical subject headings
- Carcinoma, Ductal, Breast, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G1T38Drug
Also called lerociclib
FulvestrantDrug
Also called Faslodex
| Study group | Role | What they receive |
|---|---|---|
| Once-Daily G1T38 Dosing | Experimental | G1T38 (lerociclib) orally (once daily) in combination with fulvestrant. Receives: Drug: G1T38; Drug: Fulvestrant |
| Twice-Daily G1T38 Dosing | Experimental | G1T38 (lerociclib) orally (twice daily) in combination with fulvestrant. Receives: Drug: G1T38; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: Week 1 Day 1-Week 5 Day 1
Recommended Phase 2 dose
Measured: 14 months
Recommended Phase 2 dose interval
Twice-Daily or Once-Daily dosing
Measured: 14 months
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from the signing of the informed consent until 30 days after the last dose of study medication up to 36 months
Measured: 36 months
Secondary outcomes (7)
Tumor response based on RECIST, Version 1.1
Measured: 30 months
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Maximum Plasma Concentration (Cmax)
Measured: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Area under Curve - plasma concentration (AUC)
Measured: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma: terminal half life (T1/2)
Measured: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma - Volume of distribution
Measured: Week 1 Day 1-Week 9 Day 1
Progression free survival (PFS)
Measured: 36 months
Overall survival (OS)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Ductal, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G1 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Contact, Study director, G1 Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983071
- Sponsor's protocol ID
- G1T38-02
- Other IDs
- 2016-001485-29, 2016
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Safety, Pharmacokinetic, and Antitumor Activity Study of G1T38 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer After Endocrine Failure
- ClinicalTrials.gov ID
- NCT02983071
- Acronym / sponsor ID
- G1T38-02
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- Keywords
- Breast Cancer, CDK 4/6 Inhibitor, HER2-Negative, HR-Positive, HR+, HER2-, HER2 -ve, HER2 +ve
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- G1 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once-Daily G1T38 Dosing | Experimental | Drug: G1T38, Drug: FulvestrantG1T38 (lerociclib) orally (once daily) in combination with fulvestrant. |
| Twice-Daily G1T38 Dosing | Experimental | Drug: G1T38, Drug: FulvestrantG1T38 (lerociclib) orally (twice daily) in combination with fulvestrant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed diagnosis of HR-positive, HER2-negative breast cancer, not amenable to curative therapy
- Pre- or perimenopausal women can be enrolled if amenable to be treated with goserelin
- Patients must satisfy 1 of the following criteria for prior therapy:
- For Part 1, evaluable or measurable disease (bone only disease eligible for Part 1 only)
- For Part 2, measurable disease as defined by RECIST, Version 1.1
Key exclusion criteria (7 listed)
- For Part 1, prior treatment with fulvestrant
- For Part 2, prior treatment with any CDK inhibitor or fulvestrant
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Chemotherapy within 21 days of first G1T38 dose
- Investigational drug within 28 days of first G1T38 dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G1T38Also: lerociclib | Drug | Once-Daily G1T38 Dosing, Twice-Daily G1T38 Dosing |
| FulvestrantAlso: Faslodex | Drug | Once-Daily G1T38 Dosing, Twice-Daily G1T38 Dosing |
Primary outcome
Dose Limiting Toxicity
Time frame: Week 1 Day 1-Week 5 Day 1
Recommended Phase 2 dose
Time frame: 14 months
Recommended Phase 2 dose interval
Time frame: 14 months
Twice-Daily or Once-Daily dosing
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
Time frame: 36 months
All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from the signing of the informed consent until 30 days after the last dose of study medication up to 36 months
7 secondary outcomes
Tumor response based on RECIST, Version 1.1
Time frame: 30 months
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Maximum Plasma Concentration (Cmax)
Time frame: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Area under Curve - plasma concentration (AUC)
Time frame: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma: terminal half life (T1/2)
Time frame: Week 1 Day 1-Week 9 Day 1
Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma - Volume of distribution
Time frame: Week 1 Day 1-Week 9 Day 1
Progression free survival (PFS)
Time frame: 36 months
Overall survival (OS)
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Related trials for Carcinoma, Ductal, Breast
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
RecruitingObservational study
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
Metastatic Breast Cancer, Lobular Breast Carcinoma
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Breast Neoplasms, Carcinoma, Ductal, Breast
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Contact study director
G1 Therapeutics, Inc.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing G1T38 and Fulvestrant in people with Carcinoma, Ductal, Breast and Breast Cancer, run by G1 Therapeutics, Inc. at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Bulgaria, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: Week 1 Day 1-Week 5 Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.