Roniciclib Mass Balance Study

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390154
• Other study ID #: 15022
• Secondary ID: 2014-002797-37
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2015
• Last updated: July 14, 2016
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary:National Institute for Quality- and Organizational Development in Healthcare and Medicines" (GYEMSZI)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• roniciclib (BAY 1000394)
Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution
• 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

Locations

Country	Name	City	State
Hungary	PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Roniciclib in urine as percentage of the dose of total radioactivity.		Up to 336 hours	No
Primary	Amount of Roniciclib in feces as percentage of the dose of total radioactivity.		Up to 336 hours	No
Primary	Amount of Roniciclib in vomit as percentage of the dose of total radioactivity		Up to 336 hours	No
Primary	Cmaxof roniciclib in plasma		up to 336 hours	No
Primary	AUC(0-tlast) of roniciclib in plasma		up to 336 hours	No
Primary	AUC of roniciclib in plasma		up to 336 hours	No
Primary	Cmax of total radioactivity in whole blood and plasma		up to 336 hours	No
Primary	AUC(0-tlast) of total radioactivity in whole blood and plasma		Up to 336 hours	No
Primary	AUC of total radioactivity in whole blood and plasma		up to 336 hours	No

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