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Regorafenib and Cetuximab in Patients With Advanced Malignancy

NCT02095054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-04-01

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied.

Conditions

Interventions

DRUG

Regorafenib

Dose Escalation Group Starting Dose of Regorafenib: 80 mg by mouth once a day for 21 days (5 days on and 2 days off) in a 28 days cycle. Dose Expansion Group Starting Dose of Regorafenib : MTD from Dose Escalation Group.

DRUG

Cetuximab

Dose Escalation Group Starting Dose of Cetuximab: 200 mg/m2 initial dose, then 150 mg/m2 by vein over about 1-2 hours on Days 1, 8, 15, and 22 of each 28 day cycle. Dose Expansion Group Starting Dose of Cetuximab: MTD from Dose Escalation Group.

BEHAVIORAL

Questionnaire

Symptom questionnaire completed at each study visit.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vivek Subbiah, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-19
Primary Completion
2020-03-27
Completion
2020-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095054 on ClinicalTrials.gov