Clinical trial · Interventional
Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment
A Phase I, Multi-center, Non-randomized, Open Label, Parallel-group Study Evaluating the Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment Compared to a Control Group
NCT01853046CI-TRIAL-00026062completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the Control group (cancer subjects with normal or mildly impaired renal function)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment
- description
- Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
- type
- EXPERIMENTAL
- label
- Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment
- description
- Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * For subjects with NORMAL OR MILDLY IMPAIRED RENAL FUNCTION (Control group); to be tested within 7 days of starting the study treatment: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.