Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
Megadott ok: Sponsor decision
Key facts
- Where
- Anaheim, Canton, Fairfax, Fountain Valley és Gettysburg, Egyesült ÁllamokSee the 5 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- Pacific Cancer Medical Center INCAnaheim, Egyesült ÁllamokNo longer taking part
- Gabrail Cancer Center ResearchCanton, Egyesült ÁllamokNo longer taking part
- NEXT VirginiaFairfax, Egyesült ÁllamokNo longer taking part
- Compassionate Cancer Care Research Inc.Fountain Valley, Egyesült ÁllamokNo longer taking part
- Pennsylvania Cancer Specialists and Research InstituteGettysburg, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Nuvation Bio Inc.
- Trial code
- NCT05191004
- Record updated
- 2023. július 11.
- Original description
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.Read full original descriptionShow less
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)
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.
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; 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; For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent; Moderate liver impairment which would require a reduced dose of fulvestrant; Known allergy or hypersensitivity to fulvestrant; Females who are pregnant or breast feeding.