check_circleStudy Completed

Neoplasms

Bayer Identifier:

14484

ClinicalTrials.gov Identifier:

NCT01188252

EudraCT Number:

2010-019191-79

EU CT Number:

Not Available
Clinical study to evaluate the maximum tolerated dose of BAY1000394 given in a 3 days on / 4 days off schedule in subjects with advanced malignancies

Trial purpose

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
    - Life expectancy of at least 12 weeks
    - Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
    - At least 1 tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1
    - Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to the first dose of study drug
  • - History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
    - Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C(3)
    - History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
    - Active clinically serious infections of CTCAE > Grade 2 (CTCAE v4.02)
    - Symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. Subjects must not be on acute steroid therapy or taper off steroid therapy (chronic steroid therapy is acceptable provided that the dose is stable for 4 weeks prior to study entry and following screening CT / MRI scan). Subjects with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable
    - Seizure disorder requiring therapy (such as steroids or anti-epileptics)
    - History of organ allograft
    - Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE > Grade 2 within 4 weeks prior to prior to the first dose of study drug

Trial summary

Enrollment Goal
112
Trial Dates
August 2010 - December 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
VILLEJUIF CEDEX, 94805, France
Completed
Marseille Cedex 20, 13915, France
Completed
Herne, 44625, Germany
Completed
LYON CEDEX, 69008, France
Completed
CAEN CEDEX, 14033, France
Completed
St. Louis, 63110, United States
Completed
Heidelberg, 69120, Germany
Terminated
Cleveland, 44195, United States
Completed
Buffalo, 14263-0001, United States

Primary Outcome

  • Safety: Frequency of adverse events
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum tolerated dose: Measured by adverse event profile
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Pharmacokinetics: Plasma concentrations of BAY1000394 will be measured. The following parameters will be calculated: Cmax, tmax, AUC(0-tn), AUC, and half-life.
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Biomarkers evaluation: analysis of apoptosis marker CK18/M30 and total soluble cytokeratin CK18/M65
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Assessment of expression (IHC) and amplification status (FISH) of markers related to cell proliferation and the cell cycle in Paraffin-embedded archival tumor samples. These will include, but may not be limited to Cyclin E, Cyclin D, p21, and Ki67
    date_rangeTime Frame:
    From archival tumor blocks
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    Safety Issue:
    Yes
  • Functional testing of peripheral leucocytes, for example induction of cytokine synthesis
    date_rangeTime Frame:
    Approximately 6 weeks
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    Safety Issue:
    Yes
  • Assessment of intracellular biomarkers of apoptosis (for example activated caspase 3, annexin V, expression of MCL 1 for patients with chronic lymphocytic leucemia only
    date_rangeTime Frame:
    Approximately 6 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Tumor response evaluation based on RECIST 1.1 (solid tumors) or response based on the pertinent guidelines (malignant lymphoma, chronic lymphocytic leukemia) every 2 cycles
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An open-label, Phase I, dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY 1000394 given in a 3 days on / 4 days off schedule in subjects with advanced malignancies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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