A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
All participants received Best Supportive Care. Acronyms used in Adverse events section:
Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute
Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT),
Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio
(INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial
nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT).
Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event
collection will be covered in Adverse events section.
Inclusion Criteria:
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Progression during or within 3 months following the last administration of approved
standard therapies. Patients treated with oxaliplatin in an adjuvant setting should
have progressed during or within 6 months of completion of adjuvant therapy
- Patients with measurable or non measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of
- Life expectancy of at least 3 months
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Unstable/uncontrolled cardiac disease
- History of arterial or venous thrombotic or embolic events
- Symptomatic metastatic brain or meningeal tumors
- Patients with evidence or history of bleeding diathesis
- Interstitial lung disease - Persistent proteinuria >/= grade 3
- Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding
alopecia and oxaliplatin induced neurotoxicity
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.
Outcome Time Frame:
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
14387
NCT ID:
NCT01103323
Start Date:
April 2010
Completion Date:
January 2014
Related Keywords:
- Metastatic Colorectal Cancer
- Metastatic Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Milwaukee, Wisconsin | |
| Charleston, South Carolina | |
| Bismarck, North Dakota 58501 | |
| Salt Lake City, Utah 84112 |
