Roniciclib Mass Balance Study

A Phase I, Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics of Orally Administered [14C]-Roniciclib (BAY 1000394) in Patients With Solid Tumors

The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: roniciclib (BAY 1000394); Drug: roniciclib (BAY 1000394)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1077
    • PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Male or female subjects aged ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• 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
• Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:

Exclusion Criteria:

• Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
• History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
• Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed
• Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Open label non-randomized non-controlled mass balance study in Cycle 1	Drug: roniciclib (BAY 1000394); Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution; Drug: roniciclib (BAY 1000394); 5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days
Experimental: Arm 2; Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles	Drug: roniciclib (BAY 1000394); Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution; Drug: roniciclib (BAY 1000394); 5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.	Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.	Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity	Up to 336 hours
Cmaxof roniciclib in plasma	up to 336 hours
AUC(0-tlast) of roniciclib in plasma	up to 336 hours
AUC of roniciclib in plasma	up to 336 hours
Cmax of total radioactivity in whole blood and plasma	up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma	Up to 336 hours
AUC of total radioactivity in whole blood and plasma	up to 336 hours

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 15022; 2014-002797-37 (EudraCT Number)