Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007238

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007238
  •   2015/05/07
  •   2014/04/04
  •   no
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Secondary IDs

  •   2013-003613-18 
  •   NCT02106845  (ClinicalTrials.gov)
  •   16674  (Bayer)
  •   2013-003613-18 
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Health Condition or Problem studied

  •   Neoplasms
  •   C00-C75 -  Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
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Interventions/Observational Groups

  •   Drug: Digoxin
  •   Drug: Rosuvastatin
  •   Drug: Regorafenib (Stivarga, BAY73-4506)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Crossover
  •   I
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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
- 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
- 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
- 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

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Secondary Outcome

- Tumor Response following RECIST criteria; time frame: From first dose up to 3 months after end of treatment
- Number of participants with adverse events as a measure of safety and tolerability; time frame: Up to 30 days after last dose
- Number of participants with drug related adverse events as a measure of safety and tolerability; time frame: Up to 30 days after last dose

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/04/30
  •   50
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

-

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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.

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.