NCT02662608

Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	Brontictuzumab	1.5 mg/Kg intravenously every three weeks.

Timeline

• Start date: 2015-12-29
• Primary completion: 2016-03-06
• Completion: 2016-03-06
• First posted: 2016-01-25
• Last updated: 2017-06-14
• Results posted: 2017-05-16

Locations

1 site across 1 country: United States