Clinical Trial: Phase I Trial of BAY1251152 for Advanced Blood Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY1251152 in Patients With Advanced

Brief Summary: The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Maximum tolerated dose(MTD) [ Time Frame: 21 days ]
    To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
  • Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 30 months ]
    To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
  • Number of adverse events (AE) [ Time Frame: Up to 30 months ]
    For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms
  • Pharmacokinetics (PK) is determined by maximum concentration (Cmax) [ Time Frame: 21 days ]
  • Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC) [ Time Frame: 21 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from [ Time Frame: Up to 30 months ]

To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms


Original Secondary Outcome: Response assessment of BAY 1251152 in hematological malignancies [ Time Frame: Up to 30 months ]

To assess the clinical efficacy of BAY 1251152 using in subjects with advanced hematological neoplasms


Information By: Bayer

Dates:
Date Received: April 18, 2016
Date Started: June 17, 2016
Date Completion: February 14, 2019
Last Updated: May 17, 2017
Last Verified: May 2017