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Trial record 18 of 78 for:    vismodegib

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

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ClinicalTrials.gov Identifier: NCT01815840
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : August 4, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Basal Cell Carcinoma
Interventions Drug: Vismodegib
Drug: Placebo
Enrollment 229
Recruitment Details  
Pre-assignment Details 229 participants were enrolled in 10 countries.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Period Title: Overall Study
Started 116 113
Completed 57 50
Not Completed 59 63
Reason Not Completed
Missing             1             0
Withdrew Consent             31             30
Administrative/Other             1             3
Adverse Event             10             16
Death             2             2
Disease progression             3             2
Investigators Decision             2             3
Lost to Follow-up             3             6
Refused Treatment             5             1
Sponsor Termination Treatment             1             0
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule Total
Hide Arm/Group Description Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up Total of all reporting groups
Overall Number of Baseline Participants 116 113 229
Hide Baseline Analysis Population Description
Intent-to-Treat Analysis Population, defined as all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants 113 participants 229 participants
61.1  (13.94) 59.9  (15.35) 60.5  (14.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 113 participants 229 participants
Female
35
  30.2%
25
  22.1%
60
  26.2%
Male
81
  69.8%
88
  77.9%
169
  73.8%
1.Primary Outcome
Title Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)
Hide Description The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 114 113
Mean (Standard Deviation)
Unit of Measure: percent change
62.9  (52.01) 54.9  (54.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vismodegib Intermittent Schedule, Vismodegib Induction Followed by Intermittent Schedule
Comments The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.3
Confidence Interval (2-Sided) 95%
-22.2 to 5.7
Estimation Comments Asymptotic confidence intervals are presented for the difference between treatment arms.
2.Secondary Outcome
Title Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues
Hide Description The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.
Time Frame Baseline to Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Population, defined as all randomized participants.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 116 113
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Overall
37.1
(28.3 to 46.5)
41.6
(32.4 to 51.2)
Adverse Events
20.7
(13.7 to 29.2)
27.4
(19.5 to 36.6)
Refused Treatment
6.0
(2.5 to 12.0)
2.7
(0.6 to 7.6)
Withdrew Consent
10.3
(5.5 to 17.4)
11.5
(6.3 to 18.9)
3.Secondary Outcome
Title Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73
Hide Description The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 94 86
Mean (Standard Deviation)
Unit of Measure: percent change
82.9  (27.01) 68.0  (53.02)
4.Secondary Outcome
Title Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73
Hide Description [Not Specified]
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Population, defined as all randomized participants.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 116 113
Measure Type: Number
Unit of Measure: percentage of participants
65.5 50.4
5.Secondary Outcome
Title Percentage of Participants With New Basal Cell Carcinomas at Week 73
Hide Description [Not Specified]
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 94 86
Measure Type: Number
Unit of Measure: percentage of participants
No new lesions 76.6 74.4
1 new lesion 10.6 11.6
2 new lesions 5.3 5.8
3 new lesions 5.3 2.3
>3 new lesions 2.1 5.8
6.Secondary Outcome
Title Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)
Hide Description [Not Specified]
Time Frame Baseline; Week 85
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 90 77
Mean (Standard Deviation)
Unit of Measure: percent change
35.7  (50.25) 38.5  (55.22)
7.Secondary Outcome
Title Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)
Hide Description [Not Specified]
Time Frame Baseline; Week 97
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 84 72
Mean (Standard Deviation)
Unit of Measure: percent change
36.0  (49.48) 42.1  (57.83)
8.Secondary Outcome
Title Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)
Hide Description [Not Specified]
Time Frame Baseline; Week 125
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 95 82
Mean (Standard Deviation)
Unit of Measure: percent change
41.2  (45.23) 44.0  (42.87)
9.Secondary Outcome
Title Percentage of Participants Experiencing Any Adverse Event
Hide Description [Not Specified]
Time Frame Up to 125 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 114 113
Measure Type: Number
Unit of Measure: percentage of participants
99.1 97.3
10.Secondary Outcome
Title Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73
Hide Description The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 (“always bothered”).
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 87 79
Mean (Standard Deviation)
Unit of Measure: percent change
-14.9  (25.75) -12.6  (23.98)
11.Secondary Outcome
Title Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73
Hide Description The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 ("never bothered") to 100 (“always bothered”).
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 87 79
Mean (Standard Deviation)
Unit of Measure: percent change
-27.4  (27.71) -28.9  (28.16)
12.Secondary Outcome
Title Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73
Hide Description The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 ("never bothered") to 100 (“always bothered”).
Time Frame Baseline; Week 73
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description:
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Number of Participants Analyzed 87 79
Mean (Standard Deviation)
Unit of Measure: percent change
-9.5  (20.59) -10.3  (26.03)
Time Frame Up to 125 weeks
Adverse Event Reporting Description Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
 
Arm/Group Title Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Hide Arm/Group Description Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
All-Cause Mortality
Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   24/114 (21.05%)   23/113 (20.35%) 
Blood and lymphatic system disorders     
Anaemia  1  0/114 (0.00%)  1/113 (0.88%) 
Febrile neutropenia  1  1/114 (0.88%)  0/113 (0.00%) 
Pseudolymphoma  1  0/114 (0.00%)  1/113 (0.88%) 
Cardiac disorders     
Myocardial infarction  1  1/114 (0.88%)  1/113 (0.88%) 
Acute coronary syndrome  1  1/114 (0.88%)  0/113 (0.00%) 
Angina pectoris  1  1/114 (0.88%)  0/113 (0.00%) 
Bradycardia  1  0/114 (0.00%)  1/113 (0.88%) 
Cardiogenic shock  1  0/114 (0.00%)  1/113 (0.88%) 
Acute myocardial infarction  1  0/114 (0.00%)  1/113 (0.88%) 
Congenital, familial and genetic disorders     
Congenital cerebral cyst  1  1/114 (0.88%)  0/113 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/114 (0.88%)  0/113 (0.00%) 
Duodenal ulcer  1  1/114 (0.88%)  0/113 (0.00%) 
Gastric perforation  1  0/114 (0.00%)  1/113 (0.88%) 
Pancreatitis acute  1  1/114 (0.88%)  0/113 (0.00%) 
General disorders     
Asthenia  1  1/114 (0.88%)  1/113 (0.88%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/114 (0.00%)  1/113 (0.88%) 
Immune system disorders     
Primary amyloidosis  1  0/114 (0.00%)  1/113 (0.88%) 
Infections and infestations     
Pneumonia  1  3/114 (2.63%)  0/113 (0.00%) 
Abscess limb  1  0/114 (0.00%)  1/113 (0.88%) 
Cellulitis  1  1/114 (0.88%)  0/113 (0.00%) 
Diverticulitis  1  0/114 (0.00%)  1/113 (0.88%) 
Gastrointestinal infection  1  0/114 (0.00%)  1/113 (0.88%) 
Kidney infection  1  0/114 (0.00%)  1/113 (0.88%) 
Pyelonephritis  1  0/114 (0.00%)  1/113 (0.88%) 
Pyelonephritis acute  1  0/114 (0.00%)  1/113 (0.88%) 
Subcutaneous abscess  1  0/114 (0.00%)  1/113 (0.88%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/114 (0.88%)  0/113 (0.00%) 
Hip fracture  1  0/114 (0.00%)  1/113 (0.88%) 
Humerus fracture  1  0/114 (0.00%)  1/113 (0.88%) 
Limb injury  1  1/114 (0.88%)  0/113 (0.00%) 
Thermal burn  1  0/114 (0.00%)  1/113 (0.88%) 
Arthropod bite  1  0/114 (0.00%)  1/113 (0.88%) 
Contusion  1  0/114 (0.00%)  1/113 (0.88%) 
Investigations     
Hepatic enzyme increased  1  1/114 (0.88%)  0/113 (0.00%) 
International normalized ratio increased  1  0/114 (0.00%)  1/113 (0.88%) 
Platelet count decreased  1  1/114 (0.88%)  0/113 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/114 (0.00%)  1/113 (0.88%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/114 (0.88%)  0/113 (0.00%) 
Back pain  1  0/114 (0.00%)  1/113 (0.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/114 (0.88%)  2/113 (1.77%) 
Metastatic squamous cell carcinoma  1  1/114 (0.88%)  0/113 (0.00%) 
Spindle cell sarcoma  1  0/114 (0.00%)  1/113 (0.88%) 
Squamous cell carcinoma of skin  1  1/114 (0.88%)  0/113 (0.00%) 
Malignant melanoma in situ  1  1/114 (0.88%)  0/113 (0.00%) 
Seminoma  1  1/114 (0.88%)  0/113 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/114 (0.88%)  0/113 (0.00%) 
Lethargy  1  0/114 (0.00%)  1/113 (0.88%) 
Nervous system disorder  1  0/114 (0.00%)  1/113 (0.88%) 
Post herpetic neuralgia  1  1/114 (0.88%)  0/113 (0.00%) 
Tremor  1  0/114 (0.00%)  1/113 (0.88%) 
Transient ischaemic attack  1  1/114 (0.88%)  1/113 (0.88%) 
Psychiatric disorders     
Depression  1  0/114 (0.00%)  1/113 (0.88%) 
Personality change  1  1/114 (0.88%)  0/113 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  0/114 (0.00%)  1/113 (0.88%) 
Calculus urinary  1  0/114 (0.00%)  1/113 (0.88%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/114 (0.88%)  1/113 (0.88%) 
Acute respiratory failure  1  0/114 (0.00%)  1/113 (0.88%) 
Chronic obstructive pulmonary disease  1  1/114 (0.88%)  0/113 (0.00%) 
Skin and subcutaneous tissue disorders     
Xanthelasma  1  1/114 (0.88%)  0/113 (0.00%) 
Vascular disorders     
Haematoma  1  0/114 (0.00%)  1/113 (0.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vismodegib Intermittent Schedule Vismodegib Induction Followed by Intermittent Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   107/114 (93.86%)   108/113 (95.58%) 
Gastrointestinal disorders     
Diarrhoea  1  20/114 (17.54%)  20/113 (17.70%) 
Nausea  1  23/114 (20.18%)  14/113 (12.39%) 
Abdominal pain  1  8/114 (7.02%)  12/113 (10.62%) 
Constipation  1  9/114 (7.89%)  8/113 (7.08%) 
Abdominal pain upper  1  9/114 (7.89%)  5/113 (4.42%) 
Vomiting  1  7/114 (6.14%)  4/113 (3.54%) 
General disorders     
Fatigue  1  24/114 (21.05%)  26/113 (23.01%) 
Asthenia  1  15/114 (13.16%)  21/113 (18.58%) 
Pyrexia  1  1/114 (0.88%)  8/113 (7.08%) 
Infections and infestations     
Nasopharyngitis  1  7/114 (6.14%)  12/113 (10.62%) 
Folliculitis  1  10/114 (8.77%)  8/113 (7.08%) 
Bronchitis  1  5/114 (4.39%)  8/113 (7.08%) 
Upper respiratory tract infection  1  7/114 (6.14%)  5/113 (4.42%) 
Investigations     
Weight decreased  1  24/114 (21.05%)  21/113 (18.58%) 
Blood creatine phosphokinase increased  1  11/114 (9.65%)  15/113 (13.27%) 
Alanine aminotransferase increased  1  7/114 (6.14%)  5/113 (4.42%) 
Metabolism and nutrition disorders     
Decreased appetite  1  21/114 (18.42%)  17/113 (15.04%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  83/114 (72.81%)  94/113 (83.19%) 
Arthralgia  1  18/114 (15.79%)  16/113 (14.16%) 
Myalgia  1  18/114 (15.79%)  12/113 (10.62%) 
Back pain  1  7/114 (6.14%)  7/113 (6.19%) 
Nervous system disorders     
Dysgeusia  1  76/114 (66.67%)  75/113 (66.37%) 
Ageusia  1  13/114 (11.40%)  14/113 (12.39%) 
Headache  1  10/114 (8.77%)  14/113 (12.39%) 
Psychiatric disorders     
Insomnia  1  5/114 (4.39%)  6/113 (5.31%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/114 (5.26%)  5/113 (4.42%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  72/114 (63.16%)  73/113 (64.60%) 
Pruritus  1  8/114 (7.02%)  13/113 (11.50%) 
Actinic keratosis  1  10/114 (8.77%)  8/113 (7.08%) 
Eczema  1  6/114 (5.26%)  0/113 (0.00%) 
Rash  1  3/114 (2.63%)  7/113 (6.19%) 
Seborrhoeic dermatitis  1  6/114 (5.26%)  2/113 (1.77%) 
Vascular disorders     
Hypertension  1  2/114 (1.75%)  6/113 (5.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01815840     History of Changes
Other Study ID Numbers: MO28295
2012-003305-10 ( EudraCT Number )
First Submitted: March 19, 2013
First Posted: March 21, 2013
Results First Submitted: June 27, 2016
Results First Posted: August 4, 2016
Last Update Posted: September 28, 2017