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Trial record 3 of 31 for:    ACITRETIN

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

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: NCT02050321
Recruitment Status : Terminated (Pharmaceutical company pulled support for the trial.)
First Posted : January 30, 2014
Results First Posted : April 19, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Melanoma
Interventions Drug: Acitretin
Drug: Vemurafenib
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acitretin and Vemurafenib
Hide Arm/Group Description

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Arm/Group Title Acitretin and Vemurafenib
Hide Arm/Group Description

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
53.5
(52 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Rate of Development of cSCC at 6 Months (Biopsy Confirmed).
Hide Description [Not Specified]
Time Frame 6 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per the PI: There is no measurable or interpretable data for this study. Only two patients were enrolled before the study closed to accrual due to recent FDA approvals of drugs for melanoma.Patients were removed from protocol prior to reaching data points or the completing the study.
Arm/Group Title Acitretin and Vemurafenib
Hide Arm/Group Description:

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame Baseline through 30 Days post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per the PI: Although there is no measurable or interpretable data for this study. One patient had higher than normal liver lab results and was removed from study treatment due to grade and severity. Patient safety was evaluated.
Arm/Group Title Acitretin and Vemurafenib
Hide Arm/Group Description:

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
Time Frame SAEs were collected on Day 1 and Day 15 of each of the 3 cycles. End of Treatment or Early Term SAEs were collected 30 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acitretin and Vemurafenib
Hide Arm/Group Description

Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.

Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months

All-Cause Mortality
Acitretin and Vemurafenib
Affected / at Risk (%)
Total   0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Acitretin and Vemurafenib
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Hepatobiliary disorders   
Elevated Liver Values   1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiatory Infection *  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acitretin and Vemurafenib
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lee Cranmer
Organization: University of Arizona Cancer Center
Phone: 520 626-0501
EMail: lcranmer@uacc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02050321     History of Changes
Other Study ID Numbers: 1312167559
First Submitted: January 24, 2014
First Posted: January 30, 2014
Results First Submitted: March 8, 2017
Results First Posted: April 19, 2017
Last Update Posted: December 25, 2018