Study 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

Inclusion Criteria
- :
- 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.

-
Exclusion Criteria

- 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

Trial Dates

April 2014 - June 2018

Phase

Phase 1

Could I Receive a placebo

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteer

Where to participate

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

Secondary Outcome

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

Additional Information

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