check_circleStudy Completed

Neoplasms

Bayer Identifier:

16674

ClinicalTrials.gov Identifier:

NCT02106845

EudraCT Number:

2013-003613-18

EU CT Number:

Not Available
Effect of regorafenib on digoxin and rosuvastatin in patients with advanced solid malignant tumors.

Trial purpose

Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate : P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - :
    - The following criteria apply to ALL patients starting the study treatment:
     -- Patients with histologically confirmed, locally advanced or metastatic solid tumors refractory to standard therapy or in whom regorafenib is considered a standard treatment.
     -- Male or Female Caucasian patients >/= 18 years of age
     -- Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration.
     -- Life expectancy of at leat 12 weeks
     -- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
     -- Adequate bone marrow and liver function
     -- Estimated creatinine clearance (CLcr) ≥ 30 mL/min as calculated using the Cockroft-Gault (C-G) equation.
     -- Thyroid Stimulating Hormone(TSH) within normal ranges.
    - The following inclusion criteria apply to Group A (digoxin + regorafenib) patients ONLY:
     -- Potassium, magnesium and calcium blood levels within normal range according to the local laboratory.
    - The following inclusion criteria apply to Group B (rosuvastatin + regorafenib) patients ONLY:
     -- Signed genetic informed consent. Patients must be able to understand and willing to sign the written informed consent intended to screen for BCRP and OATP1B1 polymorphisms.

    -

  • - For ALL patients
    - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
    - Non-healing wound, skin ulcer, or bone fracture.
    - Ongoing or active infection.
    - Other anticancer treatment.
    - Patients unable to swallow oral medications
    - For Group A (digoxin + regorafenib):
     -- Family history of sudden cardiac death.
    - For Group B (rosuvastatin + regorafenib):
     -- Patients with porphyria.
     -- Patients with intestinal or urinary obstructions.

Trial summary

Enrollment Goal
42
Trial Dates
April 2014 - June 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Herne, 44625, Germany
Completed
Frankfurt, 60488, Germany
Completed
Freiburg, 79106, Germany
Completed
Budapest, 1083, Hungary
Completed
Budapest, 1122, Hungary

Primary Outcome

  • Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for Digoxin
    date_rangeTime Frame:
    On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) in plasma for Digoxin
    date_rangeTime Frame:
    On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for rosuvastatin
    date_rangeTime Frame:
    On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) in plasma for rosuvastatin
    date_rangeTime Frame:
    On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Tumor Response following RECIST criteria
    date_rangeTime Frame:
    From first dose up to 3 months after end of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 30 days after last dose
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with drug related adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 30 days after last dose
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Phase I, multi-center, non-randomized, open label, drug-drug-interaction study to determine the effect of multiple doses of regorafenib (BAY 73-4506) on the pharmacokinetics of probe substrates of transport proteins P-gp (digoxin; Group A) and BCRP (rosuvastatin; Group B) in patients with advanced solid malignant tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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