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A Phase I, Multi-center, Non-randomized, Open Label, Parallel-group Study Evaluating the Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Subjects With Severe Renal Impairment Compared to a Control Group


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

A Phase I, Multi-center, Non-randomized, Open Label, Parallel-group Study Evaluating the Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Subjects With Severe Renal Impairment Compared to a Control Group


Inclusion Criteria:



- Subjects with histologically confirmed, locally advanced or metastatic, refractory
solid tumors who are not candidates for standard therapy

- Male or female subject ≥ 18 years of age

- Women of childbearing potential must have a negative urine pregnancy test performed
within 7 days before start of study treatment

- Life expectancy at least 8 weeks

- Adequate bone marrow, and liver function as assessed by the following laboratory
requirements conducted within 7 days of starting the study treatment

- For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be
tested within 7 days of starting the study treatment:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

- Estimated creatinine clearance (CLcr) ≥ 60 mL/min as calculated using the
Cockcroft-Gault equation

- For subjects with SEVERELY IMPAIRED renal function; to be tested within 7 days of
starting the study treatment:

- CLcr 15-29 mL/min as calculated using the Cockcroft-Gault equation

Exclusion Criteria:

- Symptomatic metastatic brain or meningeal tumors

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
before start of study medication

- History of organ allograft

- Non-healing wound, skin ulcer, or bone fracture

- Pheochromocytoma

- Uncontrolled concurrent medical illness including uncontrolled hypertension

- History of cardiac disease

- Pleural effusion or ascites that causes respiratory compromise

- Interstitial lung disease with ongoing signs and symptoms at the time of screening

- Arterial or venous thrombotic or embolic events such as cerebrovascular accident
(including transient ischemic attacks), deep vein thrombosis or pulmonary embolism
within 6 months before the start of study medication

- Subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding
event NCI-CTCAE Grade ≥ 3 or higher within 4 weeks of start of investigational
treatment

- Dehydration NCI-CTCAEversion 4.0 Grade ≥ 1

- Unresolved toxicity higher than NCI-CTCAE version 4.0 Grade 1 attributed to any prior
therapy/procedure (excluding alopecia or anemia or grade 2 neuropathy that is not
reversible due to oxaliplatin)

- Seizure disorder requiring anticonvulsant therapy (such as steroids or
anti-epileptics)

- For subjects with SEVERELY IMPAIRED renal function:

- Renal failure requiring hemo- or peritoneal dialysis

- Acute renal failure

- Acute nephritis

- Nephrotic syndrome

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

AUC(0-tlast) [area under the concentration-time curve after single dose from time zero to the last data point >LLOQ (lower limit of quantification)] for regorafenib and its pharmacologically active metabolites M-2 and M-5

Outcome Description:

based on non-compartmental PK evaluation

Outcome Time Frame:

Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Canada: Health Canada

Study ID:

16653

NCT ID:

NCT01853046

Start Date:

June 2013

Completion Date:

December 2014

Related Keywords:

  • Neoplasms
  • Regorafenib
  • pharmacokinetics
  • safety
  • severe renal impairment
  • Solid tumors
  • Neoplasms
  • Renal Insufficiency

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