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

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Digoxin; Rosuvastatin Calcium

Criteria

• 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.