cdk4 inhibitor bgb-43395
cdk4 inhibitor bgb-43395: 7 clinical trials tracked.
cdk4 inhibitor bgb-43395 evidence translation
What we can confirm
7 tracked trials
What it means
What to watch
Prepared research question
What is verified about cdk4 inhibitor bgb-43395, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 1 study sponsors
Clinical Trial Registry Records (7)
A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates
Primary endpoint: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Primary endpoint: Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors
Primary endpoint: Phase 1a: Number of Participants with Adverse Events (AEs)
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer
Primary endpoint: Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Chinese Patients With Advanced or Metastatic HR+/HER2- Breast Cancer and Other Solid Tumors
Primary endpoint: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
Primary endpoint: Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Primary endpoint: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)