Trial Outcomes & Findings for Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC) (NCT NCT02662608)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-06-14

Participant Flow

Study recruitment was limited to single participant compassionate use in December 2015.

Participant milestones

Participant milestones
Measure	Brontictuzumab Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brontictuzumab n=1 Participants Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Sex: Female, Male Female	1 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	1 participants n=39 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Brontictuzumab n=1 Participants Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Number of Participants With Disease Progression	1 Participants

Adverse Events

Brontictuzumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brontictuzumab n=1 participants at risk Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • Adverse event collection with three week treatment cycle.

Additional Information

Dr. Renata Ferrarotto, Asst Professor/Thoracic/Head & Neck Medical Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place