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G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02983071
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
G1 Therapeutics, Inc.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Ductal, Breast Breast Cancer Breast Neoplasm Drug: G1T38 Drug: Fulvestrant Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Once-Daily G1T38 Dosing
G1T38 orally (once daily) in combination with fulvestrant.
Drug: G1T38
Drug: Fulvestrant
Other Name: Faslodex

Experimental: Twice-Daily G1T38 Dosing
G1T38 orally (twice daily) in combination with fulvestrant.
Drug: G1T38
Drug: Fulvestrant
Other Name: Faslodex




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Week 1 Day 1-Week 5 Day 1 ]
  2. Recommended Phase 2 dose [ Time Frame: 14 months ]
  3. Recommended Phase 2 dose interval [ Time Frame: 14 months ]
    Twice-Daily or Once-Daily dosing

  4. 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


Secondary Outcome Measures :
  1. Tumor response based on RECIST, Version 1.1 [ Time Frame: 30 months ]
  2. Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Maximum Plasma Concentration (Cmax) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  3. Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Area under Curve - plasma concentration (AUC) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  4. Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma: terminal half life (T1/2) [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  5. Pharmacokinetics of G1T38, Fulvestrant, and Goserelin: Plasma - Volume of distribution [ Time Frame: Week 1 Day 1-Week 9 Day 1 ]
  6. Progression free survival (PFS) [ Time Frame: 36 months ]
  7. Overall survival (OS) [ Time Frame: 48 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983071


Contacts
Contact: G1Therapeutics Clinical Contact clinicalinfo@g1therapeutics.com

Locations
Bulgaria
Infekcni oddeleni, Fakultni nemocnice v Motole Not yet recruiting
Gabrovo, Bulgaria, 5300
Principal Investigator: Blaga Baeva-Rabotilova, MD         
MHAT for Womens Health - Nadezhda OOD Recruiting
Sofia, Bulgaria, 1330
Principal Investigator: Margarita Taushanova, MD         
Comac Medical Recruiting
Sofia, Bulgaria, 1618
Principal Investigator: Marchela Koleva, MD         
Special Hospital For Active Treatment In Oncology Recruiting
Sofia, Bulgaria, 1756
Principal Investigator: Galina Kurteva, MD         
Georgia
ARENSIA Exploratory Medicine LLC Recruiting
Tbilisi, Georgia, 0112
Principal Investigator: Marina Maglakelidze, MD         
Moldova, Republic of
The Institute of Oncology Recruiting
Chisinau, Moldova, Republic of, 2025
Principal Investigator: Iurie Bulat, MD         
United Kingdom
Cambridge University Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Principal Investigator: Richard Baird, MD         
University College London Hospital (UCLH) Recruiting
London, United Kingdom, NW1 2BU
Principal Investigator: Rebecca Roylance, MD         
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
Principal Investigator: Hendrik-Tobias Arkenau, MD         
The Christie NHS Foundation Not yet recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Andrew Wardley, MD         
Sponsors and Collaborators
G1 Therapeutics, Inc.
Investigators
Study Director: Clinical Contact G1 Therapeutics, Inc.

Responsible Party: G1 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02983071     History of Changes
Other Study ID Numbers: G1T38-02
2016-001485-29 ( EudraCT Number )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by G1 Therapeutics, Inc.:
Breast Cancer
CDK 4/6 Inhibitor
HER2-Negative
HR-Positive
HR+
HER2-
HER2 -ve
HER2 +ve

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Hormones
Estradiol
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens