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Completed

NCT Number: NCT02390154

Roniciclib Mass Balance Study

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.

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Key information

Conditions

Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely

Budapest, 1077, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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(e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g.,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

Treatment and study plan

Roniciclib (BAY 1000394)

Drug

Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution

Primary outcomes

  1. Amount of Roniciclib in urine as percentage of the dose of total radioactivity.

    Time frame: Up to 336 hours

  2. Amount of Roniciclib in feces as percentage of the dose of total radioactivity.

    Time frame: Up to 336 hours

  3. Amount of Roniciclib in vomit as percentage of the dose of total radioactivity

    Time frame: Up to 336 hours

  4. Cmaxof roniciclib in plasma

    Time frame: up to 336 hours

  5. AUC(0-tlast) of roniciclib in plasma

    Time frame: up to 336 hours

  6. AUC of roniciclib in plasma

    Time frame: up to 336 hours

  7. Cmax of total radioactivity in whole blood and plasma

    Time frame: up to 336 hours

  8. AUC(0-tlast) of total radioactivity in whole blood and plasma

    Time frame: Up to 336 hours

  9. AUC of total radioactivity in whole blood and plasma

    Time frame: up to 336 hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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