Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Estrogens

Mitogens

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

NUV-422 will be administered orally at escalating dose levels in combination with fulvestrant until the recommended Phase 2 combination dose (RP2cD) is determined.

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

NUV-422 will be administered orally at the RP2cD in combination with fulvestrant.

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

NUV-422 will be administered orally at the RP2cD.

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

NUV-422 is an investigational drug for oral dosing.

NUV-422

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.

Sequential assignment or parallel assignment will be applied (in both Phase 1 and Phase 2), depending on the stage of the study at the time of a patient's enrollment.

Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

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)

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities

Nuvation Bio Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

NUV-422 will be administered orally at the RP2cD in combination with enzalutamide.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

Enzalutamide

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology

The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive, HER2-negative advanced breast cancer.

Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits.

Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

Blood samples will be collected from patients with breast cancer

Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy

Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group

Rates of adverse events from the combination of CDKi and endocrine therapy

Overall survival was defined as the time from diagnosis until death from any cause or last follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC	NCT05191004	Advanced Breast... Metastatic Brea... Breast Cancer Breast Carcinom... Cancer of the B... Cancer of Breas... Malignant Tumor... Breast Tumor	NUV-422 Fulvestrant	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC	NCT05191017	Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration Resi... Castration Resi...	NUV-422 Enzalutamide	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC	NCT05191017	Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration Resi... Castration Resi...	NUV-422 Enzalutamide	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC	NCT05191004	Advanced Breast... Metastatic Brea... Breast Cancer Breast Carcinom... Cancer of the B... Cancer of Breas... Malignant Tumor... Breast Tumor	NUV-422 Fulvestrant	18 Years -	Nuvation Bio Inc.
Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy	NCT04133207	Breast Cancer S...		18 Years -	Hellenic Cooperative Oncology Group

Spots Global Cancer Trial Database for cdk

Every month we try and update this database with for cdk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cdk

Every month we try and update this database with for cdk cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cdk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.