Roniciclib Mass Balance Study

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: roniciclib (BAY 1000394)

• Registration Number: NCT02390154
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Study Start: 2015-04
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	roniciclib (BAY 1000394)	Open label non-randomized non-controlled mass balance study in Cycle 1
Arm 2	roniciclib (BAY 1000394)	Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles

Primary Outcome Measures

Name	Time	Method
AUC(0-tlast) of roniciclib in plasma	up to 336 hours
Cmaxof roniciclib in plasma	up to 336 hours
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
Cmax of total radioactivity in whole blood and plasma	up to 336 hours
AUC of roniciclib in 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

Trial Locations

Locations (1)

PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely; 🇭🇺 Budapest, Hungary