Status:
WITHDRAWN
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
Lead Sponsor:
Nuvation Bio Inc.
Conditions:
Advanced Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 mo...
Eligibility Criteria
Inclusion
- Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer
- Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria
- Patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant
- Prior standard of care treatments must include treatment with hormonal therapy in combination with an approved CDK4/6 inhibitor
- Patients must have endocrine-resistant disease
- Have no known active or symptomatic central nervous system (CNS) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
- Life expectancy of \> 6 months
- Eligible to receive fulvestrant
- Adequate bone marrow and organ function
Exclusion
- Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422 and fulvestrant
- Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of \< 5 half-lives) for myelosuppressive agent prior to first dose of NUV-422 and fulvestrant
- Moderate liver impairment which would require a reduced dose of fulvestrant
- Requires medications that are known to be strong inducers and/or inhibitors of CYP3A4/5 enzymes
- For Phase 1b only: requires medications that are known to be moderate inducers and/or inhibitors of CYP3A4/5 enzymes
- Known allergy or hypersensitivity to fulvestrant
- For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent
- Females who are pregnant or breast feeding
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05191004
Start Date
September 1 2022
End Date
September 1 2026
Last Update
July 11 2023
Active Locations (5)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Compassionate Cancer Care Research Inc.
Fountain Valley, California, United States, 92708
3
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
4
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, United States, 17325