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Trial record 37 of 78 for:    vismodegib

Evaluation of Food Effect on Pharmacokinetics of Vismodegib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174264
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : March 15, 2016
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Neoplasm
Interventions Other: Pharmacological Study
Drug: Vismodegib
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Period Title: Single Dose Pharmacokinetics
Started 23 20 20
Completed 22 20 18
Not Completed 1 0 2
Reason Not Completed
Early progressive disease             1             0             1
Patient entered hospice care             0             0             1
Period Title: Steady-state Pharmacokinetics
Started 31 [1] 0 [2] 29 [3]
Completed 25 0 27
Not Completed 6 0 2
Reason Not Completed
Not evaluable             6             0             2
[1]
Includes 22 patients from period 1 fasting arm and 9 patients from period 1 high-fat arm
[2]
Patients in period 2 were randomized to fasting vs. fed state only.
[3]
Includes 11 patients from period 1 high-fat arm and 18 patients from period 1 low-fat arm
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal) Total
Hide Arm/Group Description

Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 23 20 20 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 20 participants 20 participants 63 participants
53
(34 to 74)
57
(24 to 71)
64
(46 to 84)
61
(24 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 20 participants 63 participants
Female
15
  65.2%
11
  55.0%
14
  70.0%
40
  63.5%
Male
8
  34.8%
9
  45.0%
6
  30.0%
23
  36.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 20 participants 63 participants
White 16 17 16 49
African-American 6 3 2 11
Hispanic 1 0 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 20 participants 20 participants 63 participants
23 20 20 63
1.Primary Outcome
Title Cmax Following Single Dose of Drug
Hide Description Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 22 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/ml
3244
(55%)
5666
(45%)
3511
(40%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm II (Vismodegib After High Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments Performed on log-transformed data.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.75
Confidence Interval (2-Sided) 90%
1.30 to 2.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments Performed on log-transformed data.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
0.81 to 1.44
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC Following Single Dose of Drug
Hide Description Area under the curve from 0-168 hours.
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 22 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
416635
(56%)
723822
(54%)
466566
(38%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm II (Vismodegib After High Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments Performed on log-transformed data.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.74
Confidence Interval (2-Sided) 90%
1.25 to 2.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method t-test, 2 sided
Comments Performed on log-transformed data.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.12
Confidence Interval (2-Sided) 90%
0.84 to 1.49
Estimation Comments [Not Specified]
3.Primary Outcome
Title Tmax`Following Single Dose of Drug
Hide Description Time of maximum drug concentration
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 22 20 18
Mean (Standard Deviation)
Unit of Measure: hours
57  (62) 44  (48) 62  (57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm II (Vismodegib After High Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Tlag Following Single Dose of Drug
Hide Description Time between drug administration and when it is first observed in the systemic circulation.
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 22 20 18
Mean (Standard Deviation)
Unit of Measure: hours
0.11  (0.17) 0.50  (0.29) 0.58  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm II (Vismodegib After High Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Ctrough Following Steady State Exposure for 14 Days
Hide Description Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 25 0 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/ml
10493
(37%)
12171
(35%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments Performed on log-transformed data.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.16
Confidence Interval (2-Sided) 90%
0.97 to 1.38
Estimation Comments [Not Specified]
6.Primary Outcome
Title Cmax Following Steady State Exposure for 14 Days
Hide Description Maximum drug concentration over 24 hours.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 25 0 27
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/ml
11449
(37%)
12950
(34%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method t-test, 2 sided
Comments Performed on log-transformed data.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.13
Confidence Interval (2-Sided) 90%
0.95 to 1.35
Estimation Comments [Not Specified]
7.Primary Outcome
Title AUC Following Steady State Exposure for 14 Days
Hide Description Area under the curve from 0 to 24 hours.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
3 and 2 patients with missing data, respectively
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 22 0 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
238740
(40%)
290896
(35%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments Performed on log-transformed data.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.22
Confidence Interval (2-Sided) 90%
1.00 to 1.48
Estimation Comments [Not Specified]
8.Primary Outcome
Title Tmax Following Steady State Exposure for 14 Days
Hide Description Time of maximum drug concentration.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 25 0 27
Mean (Standard Deviation)
Unit of Measure: hours
6.7  (9.1) 10.2  (10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Vismodegib on Empty Stomach), Arm III (Vismodegib After Low Fat Meal)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Objective Responses in Patients With Solid Tumors
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients in Arm I and 4 patients in Arm III were non-evaluable for response.
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description:

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Overall Number of Participants Analyzed 23 0 23
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame Up to 3 years.
Adverse Event Reporting Description Includes all patients who received at least one dose in the daily dosing phase of the study. Recorded are adverse events of any grade level, whether or not attributable to the study drug.
 
Arm/Group Title Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Hide Arm/Group Description

Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.

Pharmacological Study: Correlative studies

Vismodegib: Given PO

All-Cause Mortality
Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/31 (48.39%)   0/0   14/30 (46.67%) 
Blood and lymphatic system disorders       
Anemia * 1  2/31 (6.45%)  0/0  1/30 (3.33%) 
Cardiac disorders       
Chest pain - cardiac * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Paroxysmal atrial tachycardia * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Ear and labyrinth disorders       
Vertigo * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/31 (3.23%)  0/0  1/30 (3.33%) 
Colonic obstruction * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Nausea * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Stomach pain * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Vomiting * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
General disorders       
Death NOS * 1  5/31 (16.13%)  0/0  3/30 (10.00%) 
Fatigue * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Non-cardiac chest pain * 1  1/31 (3.23%)  0/0  1/30 (3.33%) 
Pain * 1  3/31 (9.68%)  0/0  1/30 (3.33%) 
Infections and infestations       
Skin infection * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Investigations       
Alanine aminotransferase increased * 1  3/31 (9.68%)  0/0  0/30 (0.00%) 
Aspartate aminotransferase increased * 1  3/31 (9.68%)  0/0  0/30 (0.00%) 
Blood bilirubin increased * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Lymphocyte count decreased * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Neutrophil count decreased * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Metabolism and nutrition disorders       
Hypercalcemia * 1  1/31 (3.23%)  0/0  1/30 (3.33%) 
Hyponatremia * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other * 1  1/31 (3.23%)  0/0  1/30 (3.33%) 
Nervous system disorders       
Dizziness * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Memory impairment * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Psychiatric disorders       
Delirium * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Renal and urinary disorders       
Hematuria * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis * 1  1/31 (3.23%)  0/0  0/30 (0.00%) 
Cough * 1  0/31 (0.00%)  0/0  1/30 (3.33%) 
Dyspnea * 1  5/31 (16.13%)  0/0  5/30 (16.67%) 
Vascular disorders       
Thromboembolic event * 1  1/31 (3.23%)  0/0  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Vismodegib on Empty Stomach) Arm II (Vismodegib After High Fat Meal) Arm III (Vismodegib After Low Fat Meal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/31 (100.00%)   0/0   30/30 (100.00%) 
Blood and lymphatic system disorders       
Anemia * 1  14/31 (45.16%)  0/0  10/30 (33.33%) 
Ear and labyrinth disorders       
Ear pain * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Gastrointestinal disorders       
Abdominal pain * 1  4/31 (12.90%)  0/0  5/30 (16.67%) 
Bloating * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Constipation * 1  4/31 (12.90%)  0/0  8/30 (26.67%) 
Diarrhea * 1  7/31 (22.58%)  0/0  4/30 (13.33%) 
Dry mouth * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Gastrointestinal disorders - Other * 1  1/31 (3.23%)  0/0  2/30 (6.67%) 
Nausea * 1  12/31 (38.71%)  0/0  11/30 (36.67%) 
Vomiting * 1  7/31 (22.58%)  0/0  6/30 (20.00%) 
General disorders       
Chills * 1  3/31 (9.68%)  0/0  2/30 (6.67%) 
Edema limbs * 1  2/31 (6.45%)  0/0  4/30 (13.33%) 
Fatigue * 1  13/31 (41.94%)  0/0  15/30 (50.00%) 
Fever * 1  4/31 (12.90%)  0/0  0/30 (0.00%) 
Flu like symptoms * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Non-cardiac chest pain * 1  3/31 (9.68%)  0/0  3/30 (10.00%) 
Pain * 1  6/31 (19.35%)  0/0  13/30 (43.33%) 
Injury, poisoning and procedural complications       
Fall * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  4/31 (12.90%)  0/0  8/30 (26.67%) 
Alkaline phosphatase increased * 1  9/31 (29.03%)  0/0  5/30 (16.67%) 
Aspartate aminotransferase increased * 1  6/31 (19.35%)  0/0  5/30 (16.67%) 
Blood bilirubin increased * 1  3/31 (9.68%)  0/0  5/30 (16.67%) 
Creatinine increased * 1  4/31 (12.90%)  0/0  3/30 (10.00%) 
Lymphocyte count decreased * 1  14/31 (45.16%)  0/0  6/30 (20.00%) 
Platelet count decreased * 1  2/31 (6.45%)  0/0  2/30 (6.67%) 
Weight loss * 1  7/31 (22.58%)  0/0  3/30 (10.00%) 
Metabolism and nutrition disorders       
Anorexia * 1  15/31 (48.39%)  0/0  14/30 (46.67%) 
Hypercalcemia * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Hyperglycemia * 1  17/31 (54.84%)  0/0  12/30 (40.00%) 
Hyperkalemia * 1  7/31 (22.58%)  0/0  5/30 (16.67%) 
Hypernatremia * 1  3/31 (9.68%)  0/0  2/30 (6.67%) 
Hypoalbuminemia * 1  8/31 (25.81%)  0/0  8/30 (26.67%) 
Hypocalcemia * 1  3/31 (9.68%)  0/0  5/30 (16.67%) 
Hypokalemia * 1  3/31 (9.68%)  0/0  0/30 (0.00%) 
Hypomagnesemia * 1  3/31 (9.68%)  0/0  3/30 (10.00%) 
Hyponatremia * 1  6/31 (19.35%)  0/0  3/30 (10.00%) 
Hypophosphatemia * 1  6/31 (19.35%)  0/0  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/31 (3.23%)  0/0  3/30 (10.00%) 
Back pain * 1  4/31 (12.90%)  0/0  6/30 (20.00%) 
Flank pain * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Generalized muscle weakness * 1  1/31 (3.23%)  0/0  3/30 (10.00%) 
Myalgia * 1  8/31 (25.81%)  0/0  8/30 (26.67%) 
Pain in extremity * 1  2/31 (6.45%)  0/0  2/30 (6.67%) 
Nervous system disorders       
Dizziness * 1  4/31 (12.90%)  0/0  4/30 (13.33%) 
Dysgeusia * 1  8/31 (25.81%)  0/0  13/30 (43.33%) 
Headache * 1  5/31 (16.13%)  0/0  3/30 (10.00%) 
Peripheral sensory neuropathy * 1  3/31 (9.68%)  0/0  7/30 (23.33%) 
Psychiatric disorders       
Depression * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Insomnia * 1  5/31 (16.13%)  0/0  1/30 (3.33%) 
Renal and urinary disorders       
Renal and urinary disorders - Other * 1  2/31 (6.45%)  0/0  1/30 (3.33%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/31 (16.13%)  0/0  4/30 (13.33%) 
Dyspnea * 1  8/31 (25.81%)  0/0  8/30 (26.67%) 
Nasal congestion * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Pneumothorax * 1  2/31 (6.45%)  0/0  0/30 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  5/31 (16.13%)  0/0  3/30 (10.00%) 
Dry skin * 1  0/31 (0.00%)  0/0  2/30 (6.67%) 
Skin and subcutaneous tissue disorders - Other * 1  3/31 (9.68%)  0/0  1/30 (3.33%) 
Vascular disorders       
Hypotension * 1  2/31 (6.45%)  0/0  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theodore Karrison
Organization: University of Chicago
Phone: 773-702-9326
EMail: tkarrison@health.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01174264     History of Changes
Other Study ID Numbers: NCI-2012-03099
NCI-2012-03099 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI 8395
09-149-B ( Other Identifier: University of Chicago Comprehensive Cancer Center )
8395 ( Other Identifier: CTEP )
P30CA014599 ( U.S. NIH Grant/Contract )
U01CA069852 ( U.S. NIH Grant/Contract )
First Submitted: July 30, 2010
First Posted: August 3, 2010
Results First Submitted: February 16, 2016
Results First Posted: March 15, 2016
Last Update Posted: May 19, 2017