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Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

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ClinicalTrials.gov Identifier: NCT02457351
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.

To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients


Condition or disease Intervention/treatment Phase
Medical Oncology Drug: Roniciclib (BAY 1000394) Drug: Itraconazole (Sporanox) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Roniciclib + Itraconazole
Pharmacokinetics and safety in patients with advanced solid tumor
Drug: Roniciclib (BAY 1000394)

Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data)

Part 1 & Part 2

Cycle 2 and subsequent 21-day cycles:

Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose


Drug: Itraconazole (Sporanox)
Part 1 & Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd




Primary Outcome Measures :
  1. Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole) [ Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing ]
  2. Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole) [ Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing ]
  3. Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole) [ Time Frame: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing ]
  4. Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole) [ Time Frame: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing ]

Secondary Outcome Measures :
  1. Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
  2. Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
    Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test

  3. Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
  4. East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
  5. Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
  6. Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole [ Time Frame: up to 15 months ]
  7. Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole) [ Time Frame: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing ]
  8. Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole) [ Time Frame: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate 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.
  • Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
  • ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.
  • Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.

Exclusion Criteria:

Medical and surgical history:

  • Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism.
  • History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management)
  • Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) > Grade 2.
  • 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.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • History of organ allograft.
  • Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment

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): NCT02457351


Locations
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Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02457351     History of Changes
Other Study ID Numbers: 17616
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by Bayer:
Phase 1
Advanced solid tumor
pan-CDK inhibitor
Drug-drug Interaction

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors