Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer

NCT02465502 | Completed Phase 2

• 1 other identifier: 17217
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy (as measured by progression-free survival \[PFS\] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic therapy.

Conditions

Colorectal Neoplasms

Keywords

Colorectal cancer; Regorafenib

Outcome Measures

Primary Outcomes (1)

• Percentage of participants without disease progression or death at the end of 8 weeks

  At week 8

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  Approximately 2 months

• Overall Survival (OS)

  Approximately 2 months

• Overall Response Rate (ORR)

  Approximately 2 months

• Disease Control Rate (DCR)

  Approximately 2 months

• Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET)

  Approximately 2 months

Study Arms (1)

Regorafenib (BAY73-4506)

EXPERIMENTAL

Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506) DRUG

Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Regorafenib (BAY73-4506)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age;
• Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
• Subjects with metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to standard chemotherapy based on fluoropyrimidine, oxaliplatin, irinotecan, and an anti-EGFR therapy if RAS wild-type. This progression must be during or within 4 months following the last administration of standard therapies.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate bone-marrow, liver, and renal function
• Women of childbearing potential and men must agree to use adequate contraception when sexually active during the study and for at least 8 weeks after the last study drug administration.

You may not qualify if:

• Prior treatment with an antiangiogenic agent;
• Congestive heart failure of New York Heart Association (NYHA) class 2 or worse;
• Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug;
• Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Uncontrolled hypertension (systolic blood pressure \>140 mmHg or diastolic pressure \>90 mmHg despite optimal medical management);
• Ongoing acute or chronic infection (\> Grade 2 NCI-CTCAE v 4.03);
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication) events within 6 months of study enrollment. Subjects being treated with low-weight heparin are allowed to participate as long as dose is limited to prophylactic use.
• Any history of or currently known brain metastases (head CT/MRI will be performed during screening period if brain metastases are suspected)
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years before study entry, except for curatively treated cervical cancer in situ, in situ ductal breast cancer, non-melanoma skin cancer and superficial bladder tumors;
• Last chemotherapy dose or any other anti-cancer therapy administered in less than 4 weeks from start of study treatment;
• Use of therapeutic anticoagulation;
• Proteinuria \> 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 4.03) on urinalysis screening result. If there is medical history of proteinuria, previous urinalysis results should be considered and/or performed so at least 2 results separated by at least 2 weeks are available;
• History of interstitial lung disease with ongoing signs and symptoms at the time of informed consent;
• Non-healing wound, non-healing ulcer, or non-healing bone fracture;
• Subjects with evidence or history of any bleeding diathesis, irrespective of severity;

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

São Paulo, 01246000, Brazil

Location

Related Publications (1)

• Riechelmann RP, Leite LS, Bariani GM, Glasberg J, Rivelli TG, da Fonseca LG, Nebuloni DR, Braghiroli MI, Queiroz MA, Isejima AM, Kappeler C, Kikuchi L, Hoff PM. Regorafenib in Patients with Antiangiogenic-Naive and Chemotherapy-Refractory Advanced Colorectal Cancer: Results from a Phase IIb Trial. Oncologist. 2019 Sep;24(9):1180-1187. doi: 10.1634/theoncologist.2019-0067. Epub 2019 Jun 7.

  PMID: 31175167 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 8, 2015
• Study Start: July 21, 2015
• Primary Completion: May 2, 2017
• Study Completion: December 11, 2017
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

BR (1)