Regorafenib in Metastatic Colorectal Cancer

NCT ID: NCT02466009

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2022-03-09

Brief Summary

The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

Detailed Description

Subjects will be asked to participate in the study because they are aged 70 or older and require treatment for colorectal cancer that has spread to other parts of the body and has not gotten better with other treatment. Subjects will undergo some initial tests to ensure that they meet all criteria necessary to participate in the study. Once the subject has completed initial testing and meets eligibility criteria, the subject will begin treatment with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the subjects health status. During the study, assessments will be performed to monitor the subjects tolerance and response to the treatment. Regorafenib will continue as long as the subject is tolerating the treatment and the subjects colorectal cancer is either responding to treatment or remains stable.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regorafenib

120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)

Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.

Group Type: EXPERIMENTAL

Regorafenib

Intervention Type: DRUG

Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).

Interventions

Regorafenib

Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).

Intervention Type: DRUG

Other Intervention Names

Stivarga

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed colorectal adenocarcinoma
• Measurable metastatic disease.
• Age +/> 70
• Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
• Life expectancy >/= 12 weeks
• Able to understand and willing to sign written informed consent.
• Laboratory requirements:
• Total bili ≤ 1.5 x upper limit or normal
• Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
• Serum creatinine ≤ 1.5 x upper limit or normal
• International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
• Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
• Glomerular filtration rate ≥ 60 ml/min
• Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
• Must be able to swallow and retain oral medications

Exclusion Criteria

• Currently receiving other systemic therapy for metastatic colorectal cancer
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Uncontrolled hypertension despite optimal medical management
• Active or clinically significant cardiac disease.
• Evidence or history of bleeding diathesis or coagulopathy
• Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
• History of other active malignancy within past 2 years.
• Patients with phaeochromocytoma
• Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
• Ongoing infection > grade 2
• Symptomatic metastatic brain or meningeal tumors
• Presence of non-healing wound, non-healing ulcer, or bone fracture
• Renal failure requiring hemo- or peritoneal dialysis
• Dehydration ≥ grade 1
• Patients with seizure disorder requiring medication
• Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
• Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
• History of organ allograft including corneal transplant
• Known or suspected allergy or hypersensitivity to the study drug
• Any malabsorption condition
• Any condition which makes the subject unsuitable for trial participation
• Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Aram Hezel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aram Hezel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Mayo Clinic

Rochester, Minnesota, United States

University of Rochester

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.

Reference Type: DERIVED

PMID: 28712102 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

55555

Identifier Type: -

Identifier Source: org_study_id