Clinical trial NCT02745743: Phase I Trial of BAY1251152 for Advanced Blood Cancers
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 Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Neoplasms
Keywords: Phase 1
Dose escalation
Dose expansion
Positive transcription elongation factor b inhibitor
Cyclin-dependent kinase 9 inhibitor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks
* Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol
* Patients with confirmed advanced hematological malignancies
* Negative serum pregnancy test
* Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
* Ability to understand and the willingness to sign a written informed consent.
* Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ≤1.5 times ULN)
* Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Exclusion Criteria:

* Presence of active/uncontrolled central nervous system involvement
* History of clinically significant cardiac disease; uncontrolled hypertension
* Left ventricular ejection fraction (LVEF) \< 45%
* Allogeneic stem cell transplant within 100 days before first dose of study drug
* Known history of human immunodeficiency virus (HIV) infection
* Chronic or active hepatitis B or C, requiring antiviral therapy
* Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study
* Serious, uncontrolled infection
* Unresolved chronic toxicity \> grade 1 from prior therapy
* Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study

Primary outcomes:
measure: Maximum tolerated dose(MTD)
timeFrame: 21 days
measure: Recommended Phase 2 dose (RP2D)
timeFrame: Up to 30 months
measure: Number of adverse events (AE)
timeFrame: Up to 30 months
measure: Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
timeFrame: 21 days
measure: Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
timeFrame: 21 days
Secondary outcomes:
measure: Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
city: Dresden
country: Germany
state: Sachsen
city: Madrid
country: Spain
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: