Evaluation of Food Effect on Pharmacokinetics of Vismodegib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01174264
First received: July 30, 2010
Last updated: April 14, 2016
Last verified: April 2016
Results First Received: February 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Neoplasm
Interventions: Other: Pharmacological Study
Drug: Vismodegib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Vismodegib on Empty Stomach)

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

Arm II (Vismodegib After High Fat Meal)

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

Arm III (Vismodegib After Low Fat Meal)

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


Participant Flow for 2 periods

Period 1:   Single Dose Pharmacokinetics
    Arm I (Vismodegib on Empty Stomach)     Arm II (Vismodegib After High Fat Meal)     Arm III (Vismodegib After Low Fat Meal)  
STARTED     23     20     20  
COMPLETED     22     20     18  
NOT COMPLETED     1     0     2  
Early progressive disease                 1                 0                 1  
Patient entered hospice care                 0                 0                 1  

Period 2:   Steady-state Pharmacokinetics
    Arm I (Vismodegib on Empty Stomach)     Arm II (Vismodegib After High Fat Meal)     Arm III (Vismodegib After Low Fat Meal)  
STARTED     31 [1]   0 [2]   29 [3]
COMPLETED     25     0     27  
NOT COMPLETED     6     0     2  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Vismodegib on Empty Stomach)

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

Arm II (Vismodegib After High Fat Meal)

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

Arm III (Vismodegib After Low Fat Meal)

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 Total of all reporting groups

Baseline Measures
    Arm I (Vismodegib on Empty Stomach)     Arm II (Vismodegib After High Fat Meal)     Arm III (Vismodegib After Low Fat Meal)     Total  
Number of Participants  
[units: participants]
  23     20     20     63  
Age  
[units: years]
Median (Full Range)
  53  
  (34 to 74)  
  57  
  (24 to 71)  
  64  
  (46 to 84)  
  61  
  (24 to 84)  
Gender  
[units: participants]
       
Female     15     11     14     40  
Male     8     9     6     23  
Race/Ethnicity, Customized  
[units: participants]
       
White     16     17     16     49  
African-American     6     3     2     11  
Hispanic     1     0     2     3  
Region of Enrollment  
[units: participants]
       
United States     23     20     20     63  



  Outcome Measures
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1.  Primary:   Cmax Following Single Dose of Drug   [ Time Frame: 168 hours ]

2.  Primary:   AUC Following Single Dose of Drug   [ Time Frame: 168 hours ]

3.  Primary:   Tmax`Following Single Dose of Drug   [ Time Frame: 168 hours ]

4.  Primary:   Tlag Following Single Dose of Drug   [ Time Frame: 168 hours ]

5.  Primary:   Ctrough Following Steady State Exposure for 14 Days   [ Time Frame: 24 hours ]

6.  Primary:   Cmax Following Steady State Exposure for 14 Days   [ Time Frame: 24 hours ]

7.  Primary:   AUC Following Steady State Exposure for 14 Days   [ Time Frame: 24 hours ]

8.  Primary:   Tmax Following Steady State Exposure for 14 Days   [ Time Frame: 24 hours ]

9.  Secondary:   Objective Responses in Patients With Solid Tumors   [ Time Frame: Up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Theodore Karrison
Organization: University of Chicago
phone: 773-702-9326
e-mail: tkarrison@health.bsd.uchicago.edu



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 ( US NIH Grant/Contract Award Number )
U01CA069852 ( US NIH Grant/Contract Award Number )
Study First Received: July 30, 2010
Results First Received: February 16, 2016
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration