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Trial record 12 of 128 for:    Adenoid Cystic Carcinoma

Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

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: NCT02662608
Recruitment Status : Completed
First Posted : January 25, 2016
Results First Posted : May 16, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenoid Cystic Carcinoma
Intervention Drug: Brontictuzumab
Enrollment 1
Recruitment Details Study recruitment was limited to single participant compassionate use in December 2015.
Pre-assignment Details  
Arm/Group Title Brontictuzumab
Hide Arm/Group Description Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Brontictuzumab
Hide Arm/Group Description Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Participants With Disease Progression
Hide Description Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brontictuzumab
Hide Arm/Group Description:
Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame Adverse event collection with three week treatment cycle.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brontictuzumab
Hide Arm/Group Description Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
All-Cause Mortality
Brontictuzumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brontictuzumab
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brontictuzumab
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Diarrhea  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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. Renata Ferrarotto, Asst Professor/Thoracic/Head & Neck Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02662608     History of Changes
Other Study ID Numbers: CIND15-0074
First Submitted: January 22, 2016
First Posted: January 25, 2016
Results First Submitted: April 3, 2017
Results First Posted: May 16, 2017
Last Update Posted: June 14, 2017