Clinical trial NCT02390154: Roniciclib Mass Balance Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
timeFrame: Up to 336 hours
measure: Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
timeFrame: Up to 336 hours
measure: Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
timeFrame: Up to 336 hours
measure: Cmaxof roniciclib in plasma
timeFrame: up to 336 hours
measure: AUC(0-tlast) of roniciclib in plasma
timeFrame: up to 336 hours
measure: AUC of roniciclib in plasma
timeFrame: up to 336 hours
measure: Cmax of total radioactivity in whole blood and plasma
timeFrame: up to 336 hours
measure: AUC(0-tlast) of total radioactivity in whole blood and plasma
timeFrame: Up to 336 hours
measure: AUC of total radioactivity in whole blood and plasma
timeFrame: up to 336 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: