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OpenTrials
Completed

NCT Number: NCT01973868

Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

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)

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

Cetuximab (Erbitux)

Drug

Primary outcomes

  1. Maximum tolerated dose (MTD) of regorafenib in combination with cetuximab

    Time frame: 1 month

    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

  2. Number of participants with Adverse Events as a measure of safety and tolerability

    Time frame: Up to 2 years or longer

  3. Cmax,md (Cmax after multiple dose) for regorafenib and cetuximab

    Time frame: Multiple time points on Day 15

  4. AUC(0-24)md (AUC from time zero to 24 hours after multiple-dose administration) for regorafenib

    Time frame: Multiple time points on Day 15

  5. AUC(0-26)md (AUC from time zero to 26 hours after multiple-dose administration) for cetuximab

    Time frame: Multiple time points on Day 15

Secondary outcomes

  1. Tumor response according to RECIST 1.1

    Time frame: Up to 2 years or longer

  2. tmax,md (tmax after multiple-dose administration) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab

    Time frame: Multiple time points on Day 15

  3. tlast,md (tlast after multiple dosing) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab

    Time frame: Multiple time points on Day 15

  4. Cmax,md for metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752)

    Time frame: Multiple time points on Day 15

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 1, 2013
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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