Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma
NCT02023333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2025-08-27
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
Interventions
- 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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
State University of New York - Downstate Medical Center
collaborator OTHER -
Queens Cancer Center of Queens Hospital
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-10
- Primary Completion
- 2025-08-26
- Completion
- 2025-08-26
Countries
- United States
Study Locations
More Related Trials
-
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
NCT01949194 ·Status: UNKNOWN ·Phase: PHASE2
-
Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
NCT02465502 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment
NCT02287727 ·Status: WITHDRAWN ·Phase: PHASE2
-
Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
NCT01538680 ·Status: NO_LONGER_AVAILABLE
-
Study Comparing Different Dose Approaches of Induction Treatment of Regorafenib in MCRC
NCT02835924 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
NCT01189903 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy
NCT01959269 ·Status: COMPLETED
-
Safety and Effectiveness of Regorafenib
NCT02042144 ·Status: COMPLETED
-
Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer
NCT01875380 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
NCT01853319 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
NCT02053376 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
NCT02788006 ·Status: COMPLETED ·Phase: PHASE2
-
Identification of Predictive Biomarker of Regorafenib in Refractory Colorectal Cancer
NCT01996969 ·Status: COMPLETED ·Phase: NA
-
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
NCT01584830 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?
NCT02287025 ·Status: TERMINATED ·Phase: PHASE4
-
Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer
NCT03712943 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer
NCT02664077 ·Status: TERMINATED ·Phase: PHASE3
-
Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
NCT04110093 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment
NCT06137170 ·Status: COMPLETED
-
Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer
NCT02619435 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation and SDHB Deficient GIST) in the Post-imatinib Second-line Setting.
NCT06087263 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
NCT02096354 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas
NCT03722108 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)
NCT05818267 ·Status: RECRUITING ·Phase: NA
-
STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
NCT07213570 ·Status: RECRUITING ·Phase: PHASE2