check_circleStudy Completed

Neoplasms

Roniciclib Mass Balance Study

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 99 Years
  • - - 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
  • - 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(e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g.,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)

Trial summary

Enrollment Goal
7
Trial Dates
April 2015 - June 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. VizsgalohelyBudapest, 1077, Hungary

Primary Outcome

  • Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cmaxof roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) of roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC of roniciclib in plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    Up to 336 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC of total radioactivity in whole blood and plasma
    date_rangeTime Frame:
    up to 336 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2