Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05191004
Status:
WITHDRAWN
Last Update Posted:
2023-07-11
First Post:
2021-12-22
Brief Title:
Study of NUV-422 in Combination With Fulvestrant in Patients With HRHER2- aBC
Sponsor:
Nuvation Bio Inc
Organization:
Nuvation Bio Inc
Study Overview
Official Title:
Randomized Non-Comparative Phase 12 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative HRHER2- Advanced Breast Cancer aBC
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NUV-422-03 is a randomized non-comparative Phase 12 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy The study population is comprised of adults with HRHER2- aBC Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter Patients will be treated until disease progression toxicity withdrawal of consent or termination of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None