Spots Global Cancer Trial Database for Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
Official Title: Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)
Study ID: NCT05191004
Study Description
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 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- 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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Compassionate Cancer Care Research Inc., Fountain Valley, California, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Pennsylvania Cancer Specialists and Research Institute, Gettysburg, Pennsylvania, United States
NEXT Virginia, Fairfax, Virginia, United States
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
