Back to resultsCompassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)
Primary Purpose
Adenoid Cystic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brontictuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Adenoid Cystic Carcinoma focused on measuring Brontictuzumab
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal.
- Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression
- Capability to understand and comply with the protocol and signed informed consent document.
Exclusion Criteria:
- Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
- Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brontictuzumab
Arm Description
1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Disease Progression
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02662608
First Posted
January 22, 2016
Last Updated
May 17, 2017
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02662608
Brief Title
Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)
Official Title
NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 29, 2015 (Actual)
Primary Completion Date
March 6, 2016 (Actual)
Study Completion Date
March 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.
Detailed Description
Treatment:
Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.
Clinic Visits:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Cystic Carcinoma
Keywords
Brontictuzumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brontictuzumab
Arm Type
Experimental
Arm Description
1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.
Intervention Type
Drug
Intervention Name(s)
Brontictuzumab
Other Intervention Name(s)
OMP-52M51
Intervention Description
1.5 mg/Kg intravenously every three weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Disease Progression
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal.
Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression
Capability to understand and comply with the protocol and signed informed consent document.
Exclusion Criteria:
Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Ferrarotto, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)
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