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

NCT02457351 | Completed Phase 1

• 1 other identifier: 17616
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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

Conditions

Medical Oncology

Keywords

Phase 1; Advanced solid tumor; pan-CDK inhibitor; Drug-drug Interaction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (8)

• Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole

  up to 15 months

• Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

  up to 15 months

• Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

  up to 15 months

• 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

• Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

  up to 15 months

Study Arms (1)

Roniciclib + Itraconazole

EXPERIMENTAL

Pharmacokinetics and safety in patients with advanced solid tumor

Drug: Roniciclib (BAY 1000394); Drug: Itraconazole (Sporanox)

Interventions

Roniciclib (BAY 1000394) DRUG

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

Roniciclib + Itraconazole

Itraconazole (Sporanox) DRUG

Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd

Roniciclib + Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Hamilton, Ontario, L8V 5C2, Canada

Location

Unknown Facility

London, Ontario, N6A 4L6, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Interventions

roniciclib; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: May 29, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

CA (4)