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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02457351
Other study ID # 17616
Secondary ID
Status Completed
Phase Phase 1
First received May 28, 2015
Last updated May 20, 2016
Start date July 2015
Est. completion date April 2016

Study information

Verified date May 2016
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date April 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole) Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing No
Primary Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole) Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing No
Primary Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole) Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing No
Primary Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole) Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing No
Secondary Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole up to 15 months Yes
Secondary Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test up to 15 months Yes
Secondary Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole up to 15 months Yes
Secondary East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole up to 15 months Yes
Secondary Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole up to 15 months Yes
Secondary Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole up to 15 months Yes
Secondary Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole) Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing No
Secondary 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) Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing No
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