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Trial record 93 of 179 for:    colon cancer | ( Map: New Jersey, United States )

Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑Controlled Phase-III STudy (COAST)

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ClinicalTrials.gov Identifier: NCT01939223
Recruitment Status : Terminated
First Posted : September 11, 2013
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Placebo
Enrollment 25
Recruitment Details This multinational study was conducted at 32 study centers that screened 65 subjects across 9 countries, between 02 December 2013 (start of enrollment) and 29 August 2016 (last patient last vist).
Pre-assignment Details Overall, 65 subjects were screened, of which 40 were screen failures. The remaining 25 subjects were randomized and assigned to treatment. All 25 subjects received treatment.
Arm/Group Title Regorafenib 160 mg Placebo
Hide Arm/Group Description Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule. Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
Period Title: Overall Study
Started 14 11
Participants Received Treatment 14 11
Completed 1 0
Not Completed 13 11
Reason Not Completed
AE not assoc. with disease recurrence             1             1
Disease recurrence (radiological)             1             3
Study stopped by Sponsor             5             7
Withdrawal by Subject             6             0
Arm/Group Title Regorafenib 160 mg Placebo Total
Hide Arm/Group Description Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule. Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule. Total of all reporting groups
Overall Number of Baseline Participants 14 11 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 11 participants 25 participants
59.7  (11.22) 57.0  (9.83) 58.5  (10.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Female
9
  64.3%
5
  45.5%
14
  56.0%
Male
5
  35.7%
6
  54.5%
11
  44.0%
1.Primary Outcome
Title Disease Free Survival (DFS) as Assessed by the Investigator
Hide Description Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
Time Frame From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.
Arm/Group Title Regorafenib 160 mg Placebo
Hide Arm/Group Description:
Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.
Time Frame Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.
Arm/Group Title Regorafenib 160 mg Placebo
Hide Arm/Group Description:
Description: Subjects received regorafenib 160 milligram (mg) (4 * 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the start of study drug administration until 30 days after the last study medication intake.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regorafenib 160 mg (BAY73-4506) Placebo
Hide Arm/Group Description Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care). Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
All-Cause Mortality
Regorafenib 160 mg (BAY73-4506) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Regorafenib 160 mg (BAY73-4506) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/11 (0.00%)    
Skin and subcutaneous tissue disorders     
Erythema multiforme * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Generalised erythema * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Regorafenib 160 mg (BAY73-4506) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/14 (92.86%)      10/11 (90.91%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Febrile neutropenia * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Thrombocytopenia * 1  1/14 (7.14%)  3 0/11 (0.00%)  0
Cardiac disorders     
Atrial fibrillation * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Endocrine disorders     
Hypothyroidism * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Anal fistula * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Cheilitis * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Constipation * 1  4/14 (28.57%)  5 2/11 (18.18%)  2
Dental caries * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Diarrhoea * 1  1/14 (7.14%)  1 3/11 (27.27%)  5
Flatulence * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Gingival pain * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Nausea * 1  1/14 (7.14%)  1 1/11 (9.09%)  2
Stomatitis * 1  2/14 (14.29%)  2 2/11 (18.18%)  2
Toothache * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Vomiting * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
General disorders     
Asthenia * 1  4/14 (28.57%)  6 2/11 (18.18%)  2
Chills * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Fatigue * 1  2/14 (14.29%)  2 3/11 (27.27%)  3
Mucosal inflammation * 1  0/14 (0.00%)  0 2/11 (18.18%)  2
Non-cardiac chest pain * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Oedema * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Pyrexia * 1  3/14 (21.43%)  3 0/11 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  1/14 (7.14%)  4 0/11 (0.00%)  0
Immune system disorders     
Contrast media allergy * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations     
Abscess oral * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Device related infection * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Enterocolitis infectious * 1  1/14 (7.14%)  2 0/11 (0.00%)  0
Genital infection fungal * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Laryngitis * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Oral herpes * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Pharyngitis * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Upper respiratory tract infection * 1  1/14 (7.14%)  4 0/11 (0.00%)  0
Urinary tract infection * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications     
Humerus fracture * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Thermal burn * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Investigations     
Alanine aminotransferase increased * 1  2/14 (14.29%)  6 1/11 (9.09%)  2
Amylase increased * 1  2/14 (14.29%)  4 0/11 (0.00%)  0
Aspartate aminotransferase increased * 1  4/14 (28.57%)  10 0/11 (0.00%)  0
Blood alkaline phosphatase increased * 1  1/14 (7.14%)  2 0/11 (0.00%)  0
Blood bilirubin increased * 1  5/14 (35.71%)  7 0/11 (0.00%)  0
Blood bilirubin unconjugated increased * 1  1/14 (7.14%)  2 0/11 (0.00%)  0
Blood creatinine decreased * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Blood lactate dehydrogenase increased * 1  3/14 (21.43%)  3 0/11 (0.00%)  0
Gamma-glutamyltransferase increased * 1  1/14 (7.14%)  2 1/11 (9.09%)  1
Lipase increased * 1  4/14 (28.57%)  7 1/11 (9.09%)  4
Lymphocyte count decreased * 1  1/14 (7.14%)  2 0/11 (0.00%)  0
Neutrophil count decreased * 1  2/14 (14.29%)  3 0/11 (0.00%)  0
Neutrophil count increased * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Platelet count decreased * 1  4/14 (28.57%)  9 0/11 (0.00%)  0
Weight decreased * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Weight increased * 1  0/14 (0.00%)  0 1/11 (9.09%)  2
White blood cell count decreased * 1  3/14 (21.43%)  5 0/11 (0.00%)  0
White blood cell count increased * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
White blood cells urine positive * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  2/14 (14.29%)  2 0/11 (0.00%)  0
Diabetes mellitus * 1  0/14 (0.00%)  0 1/11 (9.09%)  2
Hyperglycaemia * 1  0/14 (0.00%)  0 1/11 (9.09%)  2
Hypertriglyceridaemia * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Hyperuricaemia * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Hypoalbuminaemia * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Hypokalaemia * 1  1/14 (7.14%)  2 1/11 (9.09%)  1
Hypomagnesaemia * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Hyponatraemia * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Hypophosphataemia * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/14 (0.00%)  0 2/11 (18.18%)  2
Bone pain * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Muscle spasms * 1  2/14 (14.29%)  2 1/11 (9.09%)  1
Musculoskeletal stiffness * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Myalgia * 1  3/14 (21.43%)  4 2/11 (18.18%)  2
Pain in extremity * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hair follicle tumour benign * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
Dizziness * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Headache * 1  1/14 (7.14%)  2 1/11 (9.09%)  1
Neuropathy peripheral * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Peripheral sensory neuropathy * 1  2/14 (14.29%)  3 0/11 (0.00%)  0
Psychiatric disorders     
Anxiety * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Renal and urinary disorders     
Dysuria * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Glycosuria * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Haematuria * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Proteinuria * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Urinary retention * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
Dysphonia * 1  5/14 (35.71%)  5 1/11 (9.09%)  1
Nasal congestion * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Oropharyngeal pain * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Productive cough * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Rhinitis atrophic * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Dermatitis acneiform * 1  1/14 (7.14%)  1 1/11 (9.09%)  1
Dermatitis bullous * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Dry skin * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Erythema multiforme * 1  1/14 (7.14%)  3 0/11 (0.00%)  0
Generalised erythema * 1  1/14 (7.14%)  2 0/11 (0.00%)  0
Hyperkeratosis * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Palmar-plantar erythrodysaesthesia syndrome * 1  6/14 (42.86%)  22 1/11 (9.09%)  1
Pruritus * 1  0/14 (0.00%)  0 1/11 (9.09%)  2
Rash * 1  2/14 (14.29%)  2 1/11 (9.09%)  1
Rash generalised * 1  1/14 (7.14%)  1 0/11 (0.00%)  0
Rash maculo-papular * 1  0/14 (0.00%)  0 1/11 (9.09%)  1
Vascular disorders     
Hypertension * 1  7/14 (50.00%)  29 1/11 (9.09%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
This study was prematurely terminated. Analysis was not performed for primary and secondary outcome measures.
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.
 
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Bayer
Phone: +49 30 300139003
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01939223     History of Changes
Other Study ID Numbers: 15983
2012-004369-42 ( EudraCT Number )
First Submitted: September 6, 2013
First Posted: September 11, 2013
Results First Submitted: August 1, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017