Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

Completed · Phase 1

Conditions studied: Neoplasms

In brief

To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

Key facts

Study ID

NCT01973868

Run by

Bayer

People needed

42

Starts

2013-11-21

Expected to finish

2018-04-03

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Pittsburgh Medical Center Health System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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