Regorafenib for Colorectal Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anti-arrhythmics, Antivirals

Disqualifiers: Hypertension, Cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the good and bad effects when regorafenib is used instead of standard combination chemotherapy. It is not known if taking regorafenib versus standard chemotherapy will have better, worse or the same results.

Who Is on the Research Team?

Andrea Cercek, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed metastatic colorectal adenocarcinoma who haven't been treated or have progressed after first-line therapy. They must have good organ function, a life expectancy of at least 3 months, and be able to take oral meds. Women must not be pregnant and all participants should agree to use contraception.

Inclusion Criteria

I can swallow and keep down pills.

My diagnosis is colorectal cancer confirmed by tissue analysis.

You are expected to live for at least 3 months.

Exclusion Criteria

I have a wound, ulcer, or bone fracture that is not healing.

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

My high blood pressure is not controlled even with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regorafenib for three weeks on and one week off, evaluated for response every 8 weeks

16 weeks

Evaluations every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Regorafenib

Trial Overview The study tests the effects of Regorafenib compared to standard chemotherapy in treating metastatic colorectal cancer. It aims to determine if Regorafenib offers better, worse, or similar outcomes as standard treatments.

How Is the Trial Designed?

Group I: Regorafenib Experimental Treatment 1 Intervention

This is an open-label, phase II study of regorafenib for patients with metastatic colorectal carcinoma. The treatment will be repeated every week for three weeks on and one week off. Patients will be evaluated for response after every 2 cycles (8 weeks).

Regorafenib is already approved in United States, European Union for the following indications:

Approved in United States as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Approved in European Union as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Queens Cancer Center of Queens Hospital

Collaborator

Trials

9

Recruited

1,100+

State University of New York - Downstate Medical Center

Collaborator

Trials

67

Recruited

12,100+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD