Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-22

Study Completion Date

2018-06-12

Brief Summary

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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

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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P-gp probe substrate(digoxin)+regorafenib

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Single dose of digoxin 0.5 mg (2 tablets 0.25 mg) orally without and with regorafenib

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Once daily orally 160 mg (4 tablets 40 mg)

Group B: BCRP probe substrate (rosuvastatin) + regorafenib

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Single dose of rosuvastatin 5mg (1 tablet 5 mg) without and with regorafenib 160 mg q.d. (4 tablets 40 mg)

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Once daily orally 160 mg (4 tablets 40 mg)

Interventions

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Digoxin

Single dose of digoxin 0.5 mg (2 tablets 0.25 mg) orally without and with regorafenib

Intervention Type DRUG

Rosuvastatin

Single dose of rosuvastatin 5mg (1 tablet 5 mg) without and with regorafenib 160 mg q.d. (4 tablets 40 mg)

Intervention Type DRUG

Regorafenib (Stivarga, BAY73-4506)

Once daily orally 160 mg (4 tablets 40 mg)

Intervention Type DRUG

Eligibility Criteria

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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.

* Potassium, magnesium and calcium blood levels within normal range according to the local laboratory.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No