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OpenTrials
Completed

NCT Number: NCT02106845

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

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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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Digoxin

Drug

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

Rosuvastatin

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)

Drug

Once daily orally 160 mg (4 tablets 40 mg)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Tumor Response following RECIST criteria

    Time frame: From first dose up to 3 months after end of treatment

  2. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 30 days after last dose

  3. Number of participants with drug related adverse events as a measure of safety and tolerability

    Time frame: Up to 30 days after last dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Apr 8, 2014
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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