Trial Condition(s):

Neoplasms

Safety and pharmacokinetics of regorafenib and cetuximab in combination

Bayer Identifier:

16547

ClinicalTrials.gov Identifier:

NCT01973868

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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)

Inclusion 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
42
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

University of Colorado Hospital

Aurora, United States, 80045

Status
Completed
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15232

Status
Completed
 

Trial Design