Trial Outcomes & Findings for RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer (NCT NCT01057277)

Last Updated: 2020-02-17

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

1 year

Results posted on

2020-02-17

Participant milestones
Measure	RAD001(Afinitor) Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47 RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Withdrawal data not reported

RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer

Baseline characteristics by cohort
Measure	RAD001(Afinitor) n=3 Participants Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47 RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	58.6 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

Timeframe: 1 year

Outcome measures
Measure	RAD001(Afinitor) n=3 Participants Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47 RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT
Response	NA participants Study was stopped early and patient's were only assessed for 6 months post drug- no responses seen

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events
Measure	RAD001(Afinitor) n=3 participants at risk Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47 RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT
Investigations vomitting	33.3% 1/3 • Number of events 1
Investigations nausea	33.3% 1/3 • Number of events 1
Investigations colitis	33.3% 1/3 • Number of events 1
Investigations acute renal failure	33.3% 1/3 • Number of events 1

Other adverse events
Measure	RAD001(Afinitor) n=3 participants at risk Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47 RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT
Investigations mucositis	33.3% 1/3 • Number of events 1
Investigations obstructed trach- mucous	33.3% 1/3 • Number of events 1
Investigations vomitting	33.3% 1/3 • Number of events 1
Investigations nausea	66.7% 2/3 • Number of events 2
Investigations diarrhea	33.3% 1/3 • Number of events 1
Investigations dehydration	66.7% 2/3 • Number of events 2
Investigations pain-mouth	33.3% 1/3 • Number of events 1
Investigations wt loss	66.7% 2/3 • Number of events 2
Investigations fatigue	66.7% 2/3 • Number of events 2
Investigations edema-face	33.3% 1/3 • Number of events 1
Investigations tinnitus	33.3% 1/3 • Number of events 1
Investigations dysphagia	33.3% 1/3 • Number of events 1
Investigations URI	33.3% 1/3 • Number of events 1
Investigations wound infection	33.3% 1/3 • Number of events 1
Investigations neuropathy	33.3% 1/3 • Number of events 1
Investigations dyspepsia	33.3% 1/3 • Number of events 1
Investigations SOB	33.3% 1/3 • Number of events 1
Investigations lymphopenia	33.3% 1/3 • Number of events 1
Investigations increased creatinine	33.3% 1/3 • Number of events 1
Investigations increased BUN	33.3% 1/3 • Number of events 1

Brown University Oncology Research Group (BrUOG)

Phone: 4018633000