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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02465502
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
• Scientific title: An Uncontrolled, Open-label Phase IIb Trial of Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
• Date of first enrolment: July 21, 2015
• Target sample size: 59
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02465502
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- Any hemorrhage or bleeding event = Grade 3 NCI-CTCAE v 4.03 within 4 weeks prior to
the start of study medication;

- Known history of human immunodeficiency virus (HIV) infection;

- History of active hepatitis B or C, or chronic hepatitis B or C requiring treatment
with antiviral therapy;

- Pregnancy or breastfeeding.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Neoplasms

Intervention(s)

Drug: Regorafenib (Stivarga, BAY73-4506)

Primary Outcome(s)

Percentage of participants without disease progression or death at the end of 8 weeks [Time Frame: At week 8]

Secondary Outcome(s)

Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET) [Time Frame: Approximately 2 months]

Overall Response Rate (ORR) [Time Frame: Approximately 2 months]

Overall Survival (OS) [Time Frame: Approximately 2 months]

Percentage of participants with grade 1 or higher adverse events, using NCI Common Terminology Criteria for Adverse Events (CTC-AE) Version 4.03 [Time Frame: Approximately 2 months]

Disease Control Rate (DCR) [Time Frame: Approximately 2 months]

Progression-Free Survival (PFS) [Time Frame: Approximately 2 months]

Secondary ID(s)

17217

Source(s) of Monetary Support

Please refer to primary and secondary sponsors