Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma

NCT02023333 | Completed Phase 2

• 1 other identifier: 13-211
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Metastatic Colorectal Adenocarcinoma

Keywords

Regorafenib; Performance Status; 13-211

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Response and progression will be evaluated in this study using the international criteria proposed by the RECIST 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.

  16 weeks

Secondary Outcomes (4)

• overall survival

  2 years

• disease control rate

  16 weeks

• duration of stable disease

  2 years

• toxicity

  2 years

Study Arms (1)

Regorafenib

EXPERIMENTAL

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).

Drug: Regorafenib

Interventions

Regorafenib DRUG

All patients that meet the eligibility criteria who have signed informed consent and have enrolled on the trial will be treated with regorafenib, daily 3 weeks on 1 week off for all cycles. Dose will be escalated to 120 mg in week 2 of cycle 1 and all remaining cycles if no excess toxicity is experienced by the patient at the discretion of the treating physician.

Also known as: BAY 73-45060

Regorafenib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Life expectancy of at least 12 weeks (3 months).
• Untreated for metastatic colorectal cancer, or progression on any first line 5-FU containing regimen (such as FOLFOX or FOLFIRI)
• Histologically proven colorectal adenocarcinoma
• Metastatic disease, unresectable disease involving one or more sites including liver, lung, lymph nodes and peritoneum, with each nodule measuring ≤3cm OR no more than two sites of disease (two nodules) \>4.5 cm.
• ECOG 0 or 1
• Adequate bone marrow, liver and liver function as assessed by the following laboratory requirements:
• Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 xULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
• Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
• Lipase ≤ 1.5 x the ULN
• Creatinine ≤ 1.5 x the ULN
• Platelet count ≥ 100000 /mm3
• hemoglobin (Hb) ≥ 9 g/dL,
• absolute neutrophil count (ANC) ≥ 1500/mm3.

You may not qualify if:

• Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v4.0\] on repeated measurement) despite optimal medical management.
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association (NYHA) \> Class II.
• Active coronary artery disease.
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
• Subjects with any previously untreated or concurrent cancer that is distinct in primary site or
• Recent history of prior cancer except cervical cancer in situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before enrollment are allowed.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Ongoing infection \> Grade 2 NCI-CTCAE v4.0.
• Symptomatic metastatic brain or meningeal tumors.
• Presence of a non-healing wound, non-healing ulcer, or bone fracture.
• Patients with seizure disorder requiring medication.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bayer: collaborator
• State University of New York - Downstate Medical Center: collaborator
• Queens Cancer Center of Queens Hospital: collaborator

Study Sites (7)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Location

Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Cancer Center Sleepy Hollow

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

regorafenib

Study Officials

• Andrea Cercek, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: December 10, 2013
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (7)