NCT02390154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

March 11, 2015

Last Update Submit

July 14, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (9)

  • 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

  • Cmaxof roniciclib in plasma

    up to 336 hours

  • AUC(0-tlast) of roniciclib in plasma

    up to 336 hours

  • AUC of roniciclib in plasma

    up to 336 hours

  • Cmax of total radioactivity in whole blood and 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Open label non-randomized non-controlled mass balance study in Cycle 1

Drug: roniciclib (BAY 1000394)

Arm 2

EXPERIMENTAL

Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles

Drug: roniciclib (BAY 1000394)

Interventions

roniciclib (BAY 1000394)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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:

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Budapest, 1077, Hungary

Location

MeSH Terms

Conditions

Neoplasms

Interventions

roniciclib

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

HU(1)