check_circleStudy Completed

Neoplasms

Bayer Identifier:

16547

ClinicalTrials.gov Identifier:

NCT01973868

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and pharmacokinetics of regorafenib and cetuximab in combination

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)

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

Trial summary

Enrollment Goal
42
Trial Dates
November 2013 - April 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Southern CaliforniaLos Angeles, 90033, United States
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Completed
University of Colorado HospitalAurora, 80045, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15232, United States

Primary Outcome

  • Maximum tolerated dose (MTD) of regorafenib in combination with cetuximab
    MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 20 %, or as the maximum dose administered, whichever is achieved first during dose escalation
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Adverse Events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years or longer
    enhanced_encryption
    Safety Issue:
    Yes
  • Cmax,md (Cmax after multiple dose) for regorafenib and cetuximab
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-24)md (AUC from time zero to 24 hours after multiple-dose administration) for regorafenib
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-26)md (AUC from time zero to 26 hours after multiple-dose administration) for cetuximab
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Tumor response according to RECIST 1.1
    date_rangeTime Frame:
    Up to 2 years or longer
    enhanced_encryption
    Safety Issue:
    No
  • tmax,md (tmax after multiple-dose administration) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No
  • tlast,md (tlast after multiple dosing) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,md for metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752)
    date_rangeTime Frame:
    Multiple time points on Day 15
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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