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A Phase 1b, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Regorafenib (BAY73-4506) in Combination With Cetuximab in Subjects With Locally Advanced or Metastatic Solid Tumors Who Are Not Candidates for Standard Therapy or in Whom Regorafenib or Cetuximab is Considered as a Standard Treatment

Description

Phase

N/A

Inclusion and Exclusion Criteria

  • Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.
  • Male or female patients ≥ 18 years of age
  • Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment
  • Life expectancy of at least 3 months
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
  • Platelet count ≥ 100,000/cubic millimeters (mm3), hemoglobin (Hb) ≥ 8.5 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,000/mm3
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects whose cancer involves their liver).
  • Amylase and lipase ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 times ULN and creatinine clearance (CLcr) ≥ 30 mL/min according to the Cockroft-Gault formula
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • Prior treatment with Regorafenib
  • Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
  • Non-healing wound, ulcer, or bone fracture
  • Systemic anticancer therapy within 28 days
  • Patients unable to swallow and retain oral medications

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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