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Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01938638
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.

The purpose of this study Part B is:

Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.


Condition or disease Intervention/treatment Phase
Neoplasms Drug: BAY1143572 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
Actual Study Start Date : September 26, 2013
Actual Primary Completion Date : August 17, 2016
Actual Study Completion Date : September 19, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BAY1143572 [continuous]
BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously
Drug: BAY1143572
Experimental: BAY1143572 [on/off]
BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule
Drug: BAY1143572



Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 2 years ]
  2. Maximum tolerated dose (MTD) of BAY1143572 [ Time Frame: Up to 1 year ]
    In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.


Secondary Outcome Measures :
  1. Maximum total drug concentration (Cmax) [ Time Frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days) ]
  2. Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24) [ Time Frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days) ]
  3. Area under the plasma concentration-time curve from time zero to infinity (AUC) [ Time Frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days) ]
  4. Time of maximum observed concentration (tmax) [ Time Frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days) ]
  5. Tumor response based on RECIST 1.1 or Cheson 2007 criteria [ Time Frame: Up to 100 weeks ]
  6. Biomarker evaluation by determination of MYC protein expression and PCNA mRNA [ Time Frame: Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days) ]
    PCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic acid



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged >/=21 years
  • Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
  • Expansion phase only: Subjects with advanced, histologically or cytologically confirmed gastric cancer, triple negative breast cancer (TNBC), or diffuse large B-cell lymphoma (DLBCL), who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
  • Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug
  • International normalized ratio (INR) and partial thromboplastin time (PTT) </=1.5 times ULN (upper limit of normal)

Exclusion Criteria:

  • Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
  • History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
  • Previous pulmonary embolism within 12 months prior to study entry
  • Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management
  • Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
  • Known history of human immunodeficiency virus (HIV) infection
  • Chronic or active hepatitis B or C, requiring antiviral therapy
  • Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent
  • Uncontrolled seizure disorder requiring therapy (such as steroids or anti-epileptics with significant CYP interaction)
  • Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of > Grade 2 within 4 weeks prior to the first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938638


Locations
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United States, Arkansas
Fayetteville, Arkansas, United States, 72703
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10032
United States, South Carolina
Charleston, South Carolina, United States, 29425
Korea, Republic of
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 169610
Taiwan
Taipei, Taiwan, 10002
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01938638     History of Changes
Other Study ID Numbers: 16519
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Bayer:
Advanced malignancies
TNBC
DLBCL
Gastric cancer