Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

Not Applicable

Completed

• Conditions: Adenoid Cystic Carcinoma
• Interventions: Drug: Brontictuzumab

• Registration Number: NCT02662608
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2015-12-29
• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Primary Completion: 2016-03-06
• Study Completion: 2016-03-06
• Results First Submitted: 2017-04-03
• Results First Submitted QC: 2017-04-03
• Status Verified: 2017-05
• Results First Posted: 2017-05-16
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brontictuzumab	Brontictuzumab	1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease Progression	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

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States