Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)
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|ClinicalTrials.gov Identifier: NCT02662608|
Recruitment Status : Completed
First Posted : January 25, 2016
Results First Posted : May 16, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: Brontictuzumab||Not Applicable|
Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.
On Day 1 of Cycle 1 and then every 3 weeks from then on:
- Participant will have a physical exam
- Blood (about 3 teaspoons) will be drawn for routine tests.
Every 6 weeks, participant will have an MRI and CT scan to check the status of the disease.
Length of Treatment:
Participant may continue taking brontictuzumab for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the drug if the disease gets worse, they develop another illness that prevents receiving more treatment, or if intolerable side effects occur.
Brontictuzumab is not FDA approved or commercially available. It is currently being used for research purposes only.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations|
|Actual Study Start Date :||December 29, 2015|
|Actual Primary Completion Date :||March 6, 2016|
|Actual Study Completion Date :||March 6, 2016|
1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.
1.5 mg/Kg intravenously every three weeks.
Other Name: OMP-52M51
- Number of Participants With Disease Progression [ Time Frame: 6 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662608
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Renata Ferrarotto, MD||M.D. Anderson Cancer Center|