Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01103323

First received: April 8, 2010

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Results First Received: October 19, 2012

Study Type:	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
Condition:	Metastatic Colorectal Cancer
Interventions:	Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Placebo

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Regorafenib (Stivarga, BAY73-4506)	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Placebo	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Total	Total of all reporting groups

Baseline Measures

	Regorafenib (Stivarga, BAY73-4506)	Placebo	Total
Number of Participants [units: participants]	505	255	760
Age ^[1] [units: Years] Mean ( Full Range )	60.7 ( 22 to 82 )	60.1 ( 25 to 85 )	60.5 ( 22 to 85 )
Gender [units: Participants]
Female	194	102	296
Male	311	153	464
Eastern Cooperative Oncology Group (ECOG) performance status (PS) before treatment ^[2] [units: Participants]
0	265	146	411
1	240	109	349
KRAS mutation ^[3] [units: Participants]
No	205	94	299
Yes	273	157	430
Unknown	27	4	31

[1]	The age of the patient in years at enrollment in the study.
[2]	ECOG PS is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare; 3= Capable of limited selfcare; 4= Completely disabled; 5= Dead
[3]	KRAS - Kirsten rat sarcoma viral oncogene homolog (protein), member of the RAS family of GTPases (guanosine triphosphate hydrolases)

Outcome Measures

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1. Primary:

Overall Survival [ 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). ]

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2. Secondary:

Progression-free Survival (Based on Investigator’s Assessment) [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

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3. Secondary:

Objective Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

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4. Secondary:

Disease Control [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

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5. Secondary:

Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ]

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Serious Adverse Events

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Reporting Groups

	Description
Regorafenib (Stivarga, BAY73-4506)	Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle
Placebo	Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle

Serious Adverse Events

	Regorafenib (Stivarga, BAY73-4506)	Placebo
Total, serious adverse events
# participants affected / at risk	220/500 (44.00%)	101/253 (39.92%)
Blood and lymphatic system disorders
DIC ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Edema: Limb ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Edema: Trunk/Genital ^{* 1}
# participants affected / at risk	0/500 (0.00%)	2/253 (0.79%)
# events	0	4
Edema: Viscera ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	3
Hemoglobin ^{* 1}
# participants affected / at risk	4/500 (0.80%)	2/253 (0.79%)
# events	8	2
INR ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	5	0
Neutrophils ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Platelets ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Thrombotic Microangiopathy ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Cardiac disorders
Cardiac Arrhythmia - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Cardiac General - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Cardiac Ischemia/Infarction ^{* 1}
# participants affected / at risk	6/500 (1.20%)	1/253 (0.40%)
# events	6	2
Hypertension ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hypotension ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Supraventricular Arrhythmia, Atrial Fibrillation ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
cTnT ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Eye disorders
Diplopia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Ocular - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Gastrointestinal disorders
Anorexia ^{* 1}
# participants affected / at risk	4/500 (0.80%)	2/253 (0.79%)
# events	6	2
Ascites ^{* 1}
# participants affected / at risk	1/500 (0.20%)	2/253 (0.79%)
# events	2	2
Constipation ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Dehydration ^{* 1}
# participants affected / at risk	3/500 (0.60%)	2/253 (0.79%)
# events	3	2
Diarrhea ^{* 1}
# participants affected / at risk	8/500 (1.60%)	0/253 (0.00%)
# events	9	0
Distension ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Enteritis ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Fistula, GI, Abdomen NOS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	2	1
Fistula, GI, Anus ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Fistula, GI, Small Bowel NOS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
GI - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Hemorrhoids ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Ileus ^{* 1}
# participants affected / at risk	2/500 (0.40%)	3/253 (1.19%)
# events	3	3
Mucositis (Functional/Symptomatic), Small Bowel ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Necrosis, GI, Peritoneal Cavity ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Obstruction, GI, Colon ^{* 1}
# participants affected / at risk	9/500 (1.80%)	6/253 (2.37%)
# events	11	8
Obstruction, GI, Ileum ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Obstruction, GI, Small Bowel NOS ^{* 1}
# participants affected / at risk	3/500 (0.60%)	7/253 (2.77%)
# events	4	9
Obstruction, GI, Stomach ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Perforation, GI, Colon ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Stricture, GI, Biliary Tree ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Ulcer, GI, Duodenum ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Vomiting ^{* 1}
# participants affected / at risk	3/500 (0.60%)	0/253 (0.00%)
# events	3	0
General disorders
Constitutional Symptoms - Other ^{* 1}
# participants affected / at risk	32/500 (6.40%)	23/253 (9.09%)
# events	47	39
Death Not Associated With CTCAE Term, Disease Progression NOS ^{* 1}
# participants affected / at risk	15/500 (3.00%)	6/253 (2.37%)
# events	16	6
Death Not Associated With CTCAE Term, Multi-Organ Failure ^{* 1}
# participants affected / at risk	4/500 (0.80%)	1/253 (0.40%)
# events	4	1
Death Not Associated With CTCAE Term, Sudden Death ^{* 1}
# participants affected / at risk	2/500 (0.40%)	2/253 (0.79%)
# events	2	2
Fatigue ^{* 1}
# participants affected / at risk	4/500 (0.80%)	5/253 (1.98%)
# events	5	5
Fever ^{* 1}
# participants affected / at risk	16/500 (3.20%)	2/253 (0.79%)
# events	20	2
Pain, Abdomen NOS ^{* 1}
# participants affected / at risk	13/500 (2.60%)	2/253 (0.79%)
# events	21	2
Pain, Back ^{* 1}
# participants affected / at risk	3/500 (0.60%)	4/253 (1.58%)
# events	5	5
Pain, Buttock ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	4	0
Pain, Cardiac/Heart ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Pain, Chest/Thorax NOS ^{* 1}
# participants affected / at risk	3/500 (0.60%)	1/253 (0.40%)
# events	3	1
Pain, Extremity - Limb ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	6	0
Pain, Head/Headache ^{* 1}
# participants affected / at risk	2/500 (0.40%)	1/253 (0.40%)
# events	2	1
Pain, Joint ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Pain, Liver ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Pain, Neuralgia/Peripheral Nerve ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Pain, Pain NOS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Pain, Tumor Pain ^{* 1}
# participants affected / at risk	2/500 (0.40%)	1/253 (0.40%)
# events	2	1
Syndromes - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Tumor Flare ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Weight Loss ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Hepatobiliary disorders
Cholecystitis ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hepatobiliary - Other ^{* 1}
# participants affected / at risk	2/500 (0.40%)	1/253 (0.40%)
# events	2	1
Liver Dysfunction ^{* 1}
# participants affected / at risk	17/500 (3.40%)	4/253 (1.58%)
# events	28	9
Immune system disorders
Allergic Reaction ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	4	0
Infections and infestations
Infection (Documented Clinically), Abdomen NOS ^{* 1}
# participants affected / at risk	4/500 (0.80%)	0/253 (0.00%)
# events	4	0
Infection (Documented Clinically), Anal/Perianal ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection (Documented Clinically), Appendix ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection (Documented Clinically), Bladder (Urinary) ^{* 1}
# participants affected / at risk	2/500 (0.40%)	1/253 (0.40%)
# events	2	1
Infection (Documented Clinically), Blood ^{* 1}
# participants affected / at risk	2/500 (0.40%)	2/253 (0.79%)
# events	4	2
Infection (Documented Clinically), Bronchus ^{* 1}
# participants affected / at risk	3/500 (0.60%)	0/253 (0.00%)
# events	3	0
Infection (Documented Clinically), Catheter-Related ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Infection (Documented Clinically), Kidney ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Infection (Documented Clinically), Lung (Pneumonia) ^{* 1}
# participants affected / at risk	9/500 (1.80%)	3/253 (1.19%)
# events	11	4
Infection (Documented Clinically), Skin (Cellulitis) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection (Documented Clinically), Soft Tissue NOS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection (Documented Clinically), Urinary Tract NOS ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Infection (Documented Clinically), Wound ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection - Other ^{* 1}
# participants affected / at risk	5/500 (1.00%)	1/253 (0.40%)
# events	6	2
Infection With Normal ANC, Blood ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Infection With Normal ANC, Catheter-Related ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection With Normal ANC, Gallbladder (Cholecystitis) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection With Normal ANC, Kidney ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection With Normal ANC, Lung (Pneumonia) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Infection With Normal ANC, Soft Tissue NOS ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Infection With Unknown ANC, Kidney ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Infection With Unknown ANC, Lung (Pneumonia) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Metabolism and nutrition disorders
AST ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Bilirubin (Hyperbilirubinemia) ^{* 1}
# participants affected / at risk	8/500 (1.60%)	4/253 (1.58%)
# events	11	4
Hypoalbuminemia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hypocalcemia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Hyponatremia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Metabolic/Lab - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Musculoskeletal and connective tissue disorders
Fracture ^{* 1}
# participants affected / at risk	3/500 (0.60%)	2/253 (0.79%)
# events	3	3
Gait/Walking ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Muscle Weakness Left-Sided ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Muscle Weakness, Extremity - Lower ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Muscle Weakness, Whole Body/Generalized ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Musculoskeletal - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Myositis ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Nervous system disorders
Ataxia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
CNS Ischemia ^{* 1}
# participants affected / at risk	1/500 (0.20%)	2/253 (0.79%)
# events	2	2
Cognitive Disturbance ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Confusion ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Dizziness ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Encephalopathy ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Neurology - Other ^{* 1}
# participants affected / at risk	2/500 (0.40%)	3/253 (1.19%)
# events	3	3
Neuropathy: Cranial, CN III Pupil, upper Eyelid, extra Ocular Mov ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Neuropathy: Motor ^{* 1}
# participants affected / at risk	3/500 (0.60%)	0/253 (0.00%)
# events	3	0
Seizure ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Somnolence ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Speech Impairment ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Syncope (Fainting) ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Renal and urinary disorders
Cystitis ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Fistula, GU, Bladder ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Obstruction, GU, Ureter ^{* 1}
# participants affected / at risk	2/500 (0.40%)	1/253 (0.40%)
# events	2	1
Renal - Other ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Renal Failure ^{* 1}
# participants affected / at risk	5/500 (1.00%)	3/253 (1.19%)
# events	6	5
Urinary Retention ^{* 1}
# participants affected / at risk	0/500 (0.00%)	2/253 (0.79%)
# events	0	2
Respiratory, thoracic and mediastinal disorders
ARDS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Cough ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Dyspnea (Shortness Of Breath) ^{* 1}
# participants affected / at risk	12/500 (2.40%)	4/253 (1.58%)
# events	18	4
Pleural Effusion ^{* 1}
# participants affected / at risk	1/500 (0.20%)	3/253 (1.19%)
# events	2	3
Pneumonitis ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Pneumothorax ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	3	0
Pulmonary - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Skin and subcutaneous tissue disorders
Dermatology - Other ^{* 1}
# participants affected / at risk	0/500 (0.00%)	2/253 (0.79%)
# events	0	3
Erythema Multiforme ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Hand-Foot Skin Reaction ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	3	0
Rash/Desquamation ^{* 1}
# participants affected / at risk	4/500 (0.80%)	1/253 (0.40%)
# events	7	1
Wound Complication, Non-Infectious ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Vascular disorders
Hematoma ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Hemorrhage - Other ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	2	0
Hemorrhage Pulmonary, Bronchus ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Hemorrhage, GI, Abdomen NOS ^{* 1}
# participants affected / at risk	2/500 (0.40%)	0/253 (0.00%)
# events	4	0
Hemorrhage, GI, Anus ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Hemorrhage, GI, Lower GI NOS ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hemorrhage, GI, Rectum ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hemorrhage, GI, Stoma ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hemorrhage, GI, Varices (Esophageal) ^{* 1}
# participants affected / at risk	0/500 (0.00%)	1/253 (0.40%)
# events	0	1
Hemorrhage, GI, Varices (Rectal) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	1	0
Hemorrhage, GU, Vagina ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0
Thrombosis/Embolism (Vascular Access) ^{* 1}
# participants affected / at risk	1/500 (0.20%)	1/253 (0.40%)
# events	1	1
Thrombosis/Thrombus/Embolism ^{* 1}
# participants affected / at risk	4/500 (0.80%)	3/253 (1.19%)
# events	4	5
Vascular - Other ^{* 1}
# participants affected / at risk	1/500 (0.20%)	0/253 (0.00%)
# events	2	0

*	Events were collected by non-systematic assessment
1	Term from vocabulary, NCI-CTCAE v.3.0

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The agreed point of publication is 12-18 months after database lock at the earliest. Bayer will have 30-45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). No publication of single center data should be done prior of publication if multi-center data.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
At 2nd IA, pre-specified O’Brien-Fleming-type efficacy boundary was crossed. DMC concluded OS result positive and after positive risk benefit assessment, recommended unblinding of study. OS from 2nd IA are the final formal and definitive results.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided by Bayer

Publications automatically indexed to this study:

Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. Epub 2012 Mar 15.

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01103323 History of Changes
Other Study ID Numbers:	14387, 2009-012787-14
Study First Received:	April 8, 2010
Results First Received:	October 19, 2012
Last Updated:	April 12, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: National Institute of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Australia: Department of Health and Ageing Therapeutic Goods Administration China: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency Brazil: National Health Surveillance Agency Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Switzerland: Swissmedic Canada: Health Canada Spain: Spanish Agency of Medicines Portugal: National Pharmacy and Medicines Institute Turkey: Ministry of Health Israel: Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Belgium: Federal Agency for Medicinal Products and Health Products United States: Food and Drug Administration

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