Status:
COMPLETED
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
Lead Sponsor:
G1 Therapeutics, Inc.
Conditions:
Carcinoma, Ductal, Breast
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (...
Eligibility Criteria
Inclusion
- For Part 1, postmenopausal women only
- For Parts 2 and 3, any menopausal status
- Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy
- For Part 1, prior treatment with less than 4 prior lines of chemotherapy
- For Part 2, prior treatment with less than 2 prior line of chemotherapy
- For Part 3, prior treatment with no more than 1 prior line of chemotherapy
- For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
- For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer
- For Parts 1 and 2, 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
- Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer
- For Part 3, patients must satisfy 1 of the following criteria for prior therapy:
- Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression
- Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior to progression
- For Part 1, evaluable or measurable disease
- For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease
- ECOG performance status 0 to 1
- Adequate organ function
Exclusion
- For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy
- Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
- Prior hematopoietic stem cell or bone marrow transplantation
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03455270
Start Date
May 9 2018
End Date
September 29 2022
Last Update
December 15 2022
Active Locations (15)
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1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
2
Stanford Women Cancer Center
Stanford, California, United States, 94305
3
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States, 60611
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305