Regorafenib in Metastatic Colorectal Cancer

NCT02466009 | Completed Phase 2 Results DMC

• 1 other identifier: 55555
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; metastatic colorectal cancer; colorectal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.

  From the date of study entry until 30 days after the last dose of study treatment.

Secondary Outcomes (2)

• Percentage of Subjects Who Responded to Study Treatment

  From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.

• Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument

  baseline and week 4

Other Outcomes (1)

• Exploratory Outcome Measure: Percentage of Patients Who Had a Correlation Between Adverse Events and Response Rate

  week 4

Study Arms (1)

Regorafenib

EXPERIMENTAL

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.

Drug: Regorafenib

Interventions

Regorafenib 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).

Also known as: Stivarga

Regorafenib

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Bayer: collaborator

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• 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.

  PMID: 28712102 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Aram Hezel
• Organization: University of Rochester

Aram_Hezel@urmc.rochester.edu

585-275-5823

Study Officials

• Aram Hezel, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: June 9, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: March 9, 2022
• Last Updated: September 4, 2024
• Results First Posted: April 6, 2021

Record last verified: 2024-08

Locations

US (4)