Trial Outcomes & Findings for Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck (NCT NCT01065844)

Results Overview

Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Every 1 to 3 months

Results posted on

2019-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Nelfinavir 1250 mg Nelfinavir twice daily Monday-Sunday Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfinavir 1250 mg Nelfinavir twice daily Monday-Sunday Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Overall Study Adverse Event	5

Baseline Characteristics

Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfinavir n=15 Participants 1250 mg Nelfinavir twice daily Monday-Sunday Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Age, Customized <=18 years	0 Participants n=99 Participants
Age, Customized Between 18 and 65 years	12 Participants n=99 Participants
Age, Customized >=65 years	3 Participants n=99 Participants
Sex/Gender, Customized Female	9 Participants n=99 Participants
Sex/Gender, Customized Male	6 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

PRIMARY outcome

Timeframe: Every 1 to 3 months

Population: Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures

Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Outcome measures

Outcome measures
Measure	Nelfinavir n=11 Participants 1250 mg Nelfinavir twice daily Monday-Sunday Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Tumor Progression Complete reponse (CR)	0 Participants
Tumor Progression Partial response (PR)	0 Participants
Tumor Progression Stable disease (SD)	7 Participants
Tumor Progression Progressive disease (PD)	4 Participants

Adverse Events

Nelfinavir

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nelfinavir n=15 participants at risk 1250 mg Nelfinavir twice daily Monday-Sunday Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday
Blood and lymphatic system disorders platelet count decreased	6.7% 1/15 • Number of events 1 • Adverse event data collected from day 1 of nelfinavir therapy through 30 days after final nelfinavir dose.
Nervous system disorders dizziness, grade 3	6.7% 1/15 • Number of events 1 • Adverse event data collected from day 1 of nelfinavir therapy through 30 days after final nelfinavir dose.
Metabolism and nutrition disorders hyponatremia, grade 4	6.7% 1/15 • Number of events 1 • Adverse event data collected from day 1 of nelfinavir therapy through 30 days after final nelfinavir dose.
Investigations Investigations - Other, liver enzymes increased, grade 3	13.3% 2/15 • Number of events 2 • Adverse event data collected from day 1 of nelfinavir therapy through 30 days after final nelfinavir dose.

Additional Information

John M. Buatti, M.D., Chair, Department of Radiation Oncology

The University of Iowa

Phone: 319-356-2699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place