Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

Adenoid Cystic Carcinoma Clinical Trial

Official title:

NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662608
• Other study ID #: CIND15-0074
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: January 18, 2017
• Start date: December 29, 2015
• Est. completion date: March 6, 2016

Study information

• Verified date: January 2017
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 6, 2016
• Est. primary completion date: March 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

2. 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.

3. Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression

4. Capability to understand and comply with the protocol and signed informed consent document.

Exclusion Criteria:

1. Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)

2. Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic

Intervention

Drug:
• Brontictuzumab
1.5 mg/Kg intravenously every three weeks.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression.	6 weeks

External Links

•   University of Texas MD Anderson Cancer Center Website