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Advanced CancersPhase 1NCT02095054

Regorafenib and Cetuximab in Patients With Advanced Malignancy

A Phase 1 study testing Regorafenib, Cetuximab and Questionnaire in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Advanced Cancers
What is being tested?
Regorafenib, Cetuximab and Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
19 Mar 2014to 27 Mar 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient must be >= 12 years of age and > 40kgs.
  • Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  • Patients must have evaluable or measurable disease by RECIST criteria for solid tumors.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must be >/= 4 weeks beyond treatment with any chemotherapy or radiotherapy, and must have recovered to </= grade 2 toxicity for any treatment-limiting toxicity of prior therapy. (Exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field). Also, patients who have received non-chemotherapeutic biologic agents will need to wait at least five half-lives or four weeks, whichever is shorter, from the last day of treatment. Exception: No washout of cetuximab or regorafenib is required for patients who have received prior cetuximab or regorafenib and have recovered from any treatment-related toxicities to Grade </= 1.
  • ECOG performance status </= 2 (Karnofsky >/= 60%).
  • Patients must have: leukocytes >/= 3,000/mL; absolute neutrophil count >/= 1,000/mL; platelets >/=100,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; AST (SGOT) and ALT(SGPT) </= 5 X ULN. Patients should not have received any platelet transfusions in the last 4 weeks before screening date.
  • Patients should not become pregnant or breastfeed while on this study. Sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose.

Who cannot join

  • KRAS mutated colorectal cancer.
  • Major surgery within 28 days prior to the first dose of study medication.
  • Pregnant or lactating women.
  • Patients with hemoptysis within 28 days prior to entering the study.
  • Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
  • Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
  • Patients with clinically significant cardiovascular disease: 1). History of CVA within 6 months; 2). Myocardial infarction or unstable angina within 6 months; 3). Unstable angina pectoris; 4). New York Heart Association Class III or greater congestive heart failure.
  • Patients with untreated or progressing brain metastases.
  • Patients who had radiation to greater than 25% marrow in the past 5 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I Trial of Regorafenib and Cetuximab in Patients With Advanced Malignancy

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.

Read the detailed description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drugs based on when you join the study.

Up to 5 dose level combinations of regorafenib and cetuximab will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level combination. Each new group will receive a higher dose of either regorafenib or cetuximab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose combination of regorafenib and cetuximab are found.

Once the highest tolerable dose combination is found, up to 10 more participants may be enrolled. This group (called the Dose Expansion group) is enrolled to help researchers study the safety and effectiveness of this dose level combination.

Study Drug Administration:

Each study cycle is 28 days.

You will take regorafenib by mouth on Days 1-5, 8-12, and 15-19 of each cycle. You will swallow the whole capsules with 1 cup of water (about 8 ounces) 1 time a day. Do not break, chew, or open your capsules. The doctor will discuss this with you.

You will receive cetuximab by vein over about 1-2 hours on Days 1, 8, 15, and 22 of each cycle.

Study Visits:

At each cycle, you will be asked to complete a questionnaire so the study team will better understand any symptoms you may be having that are related to use of the study drug.

On Day 1 of Cycle 1, blood (about 4 teaspoons) and urine will be collected for routine tests and pharmacodynamic (PD) tests. PD testing measures how the level of study drug in your body may affect the disease.

Between Days 8 and 14, Days 15 and 21, and Days 22 and 28 of Cycle 1:

°Blood (about 4 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond:

  • You will have a physical exam.
  • Urine will be collected for routine tests.

Once a week, blood (about 4 teaspoons) will be drawn for routine tests.

Every other cycle (every 8 weeks):

°You will have an x-ray and a CT scan to check the status of the disease.

Length of Study:

You may continue receiving regorafenib and cetuximab for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You will be off study after the end-of-study visit.

End of Study Visit:

About 30 days after your last dose of study drugs:

  • You will have a physical exam.
  • Blood (about 4 teaspoons) and urine will be collected for routine and PD tests tests.
  • You will have an x-ray and a CT scan to check the status of the disease.

Follow-up:

You will be asked about any health problems you may have and if you have had any side effects. If your study doctor thinks it is needed, you may have follow-up for a longer period of time.

This is an investigational study. Regorafenib is FDA approved for the treatment of metastatic colorectal cancer. Cetuximab is FDA approved for the treatment of K-Ras wild type colorectal cancer as well as head and neck cancer. The combination of regorafenib and cetuximab is currently being used in advanced solid tumor patients for research purposes only.

Up to 83 patients will be enrolled in this study. All will take part at MD Anderson.

Being tested
Regorafenib, Cetuximab, Questionnaire
Keywords
Advanced Cancers, Advanced malignancy, Metastatic cancer, Advanced solid tumor, Regorafenib, Stivarga, Cetuximab, C225, Erbitux, IMC-C225, MOAB C225, Questionnaire, Survey
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Also called Stivarga

    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.

  • CetuximabDrug

    Also called C225, Erbitux, IMC-C225, MOAB C225

    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.

  • QuestionnaireBehavioural

    Also called Survey

    Symptom questionnaire completed at each study visit.

Study groups in NCT02095054
Study groupRoleWhat they receive
Regorafenib + CetuximabExperimentalDose 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. 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. Symptom questionnaire completed at each study visit.
Receives: Drug: Regorafenib; Drug: Cetuximab; Behavioral: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Treatment with Regorafenib and Cetuximab

    MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (four weeks), determined as the highest dose studied in which the incidence of DLT is less than 33%. DLT defined as any grade 3 or 4 non-hematologic toxicity related to study medication(s) (except nausea and vomiting responsive to appropriate regimens, alopecia, or correctable electrolyte imbalances), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE that is attributable to therapy.

    Measured: 4 weeks

Secondary outcomes (2)

  1. Tumor Response of Treatment with Regorafenib and Cetuximab by RECIST Criteria

    Assessment of anti-tumor efficacy of the combination by RECIST criteria

    Measured: 4 months

  2. Tumor Response of Treatment with Regorafenib and Cetuximab by WHO Criteria

    Assessment of anti-tumor efficacy of the combination by WHO criteria.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2014 (estimated)
  2. Study start19 Mar 2014
  3. Primary completion27 Mar 2020
  4. Study completion27 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02095054
Sponsor's protocol ID
2013-0833
Other IDs
NCI-2014-01307
Status last verified
Mar 2021
First submitted
20 Mar 2014
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Subbiah V, Khawaja MR, Hong DS, Amini B, Yungfang J, Liu H, Johnson A, Schrock AB, Ali SM, Sun JX, Fabrizio D, Piha-Paul S, Fu S, Tsimberidou AM, Naing A, Janku F, Karp DD, Overman M, Eng C, Kopetz S, Meric-Bernstam F, Falchook GS. First-in-human trial of multikinase VEGF inhibitor regorafenib and anti-EGFR antibody cetuximab in advanced cancer patients. JCI Insight. 2017 Apr 20;2(8):e90380. doi: 10.1172/jci.insight.90380. eCollection 2017 Apr 20.

    PubMed 28422758

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Regorafenib, Cetuximab and Questionnaire in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Treatment with Regorafenib and Cetuximab (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02095054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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