- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188252
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
January 6, 2017 updated by: Bayer
An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen Cedex, France, 14033
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Lyon Cedex, France, 69008
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Marseille Cedex 20, France, 13915
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Villejuif Cedex, France, 94805
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69120
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Nordrhein-Westfalen
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Herne, Nordrhein-Westfalen, Germany, 44625
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Missouri
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St. Louis, Missouri, United States, 63110
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New York
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Buffalo, New York, United States, 14263-0001
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Ohio
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Cleveland, Ohio, United States, 44195
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Roniciclib
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Oral administration twice daily in a 3 days on / 4 days off schedule.
Starting dose will be 0.3 mg corresponding to approximately 0.005 mg/kg and dose will be escalated dependent on any dose limiting toxicities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: Frequency of adverse events
Time Frame: Up to 3 years or longer if indicated
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Up to 3 years or longer if indicated
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Maximum tolerated dose: Measured by adverse event profile
Time Frame: Up to 3 years or longer if indicated
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Up to 3 years or longer if indicated
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Pharmacokinetics: Plasma concentrations of BAY1000394 will be measured. The following parameters will be calculated: Cmax, tmax, AUC(0-tn), AUC, and half-life.
Time Frame: Approximately 6 weeks
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Approximately 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Biomarkers evaluation: analysis of apoptosis marker CK18/M30 and total soluble cytokeratin CK18/M65
Time Frame: Up to 3 years or longer if indicated
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Up to 3 years or longer if indicated
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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
Time Frame: From archival tumor blocks
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From archival tumor blocks
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Functional testing of peripheral leucocytes, for example induction of cytokine synthesis
Time Frame: Approximately 6 weeks
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Approximately 6 weeks
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Assessment of intracellular biomarkers of apoptosis (for example activated caspase 3, annexin V, expression of MCL 1 for patients with chronic lymphocytic leucemia only
Time Frame: Approximately 6 weeks
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Approximately 6 weeks
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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
Time Frame: Up to 3 years or longer if indicated
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Up to 3 years or longer if indicated
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 30, 2010
First Submitted That Met QC Criteria
August 24, 2010
First Posted (Estimate)
August 25, 2010
Study Record Updates
Last Update Posted (Estimate)
January 9, 2017
Last Update Submitted That Met QC Criteria
January 6, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14484
- 2010-019191-79 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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