Trial Outcomes & Findings for Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer (NCT NCT00821951)

Results Overview

maximum tolerated dose of vorinostat when given concurrently with radiation

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

1 Year

Results posted on

2020-11-20

Participant Flow

Patients at Yale New Haven Hospital were recruited for a dose escalation trial between 2009 and 2010. Eligibility criteria included a histologic diagnosis of NSCLC, and an indication for palliative thoracic radiation in patients with either metastatic disease or locally advanced disease that precluded potentially curative therapy.

ECOG PS of 0 to 2, and adequate hematologic, hepatic, and renal function were required. Patients with prolonged QT syndrome or significant cardiovascular disease were excluded, as were patients with untreated brain metastases. Prior thoracic radiation was permitted as long as a treatment field could be designed without significant overlap

Participant milestones

Participant milestones
Measure	Vorinostat and Radiotherapy Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat and Radiotherapy n=17 Participants Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	68.5 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: All participants who received any drug

maximum tolerated dose of vorinostat when given concurrently with radiation

Outcome measures

Outcome measures
Measure	Vorinostat and Radiotherapy n=16 Participants Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.
The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.	400 mg

SECONDARY outcome

Timeframe: 1 Year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year

Outcome measures

Outcome data not reported

Adverse Events

Vorinostat and Radiotherapy

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vorinostat and Radiotherapy n=16 participants at risk Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.
Metabolism and nutrition disorders hypoglycemia	6.2% 1/16 • Number of events 1 • 1 year
General disorders fatigue	12.5% 2/16 • Number of events 2 • 1 year
Metabolism and nutrition disorders hyponatremia	6.2% 1/16 • Number of events 1 • 1 year
Blood and lymphatic system disorders anemia	12.5% 2/16 • Number of events 2 • 1 year
Blood and lymphatic system disorders thrombocytopenia	6.2% 1/16 • Number of events 1 • 1 year
Blood and lymphatic system disorders hypophosphatemia	6.2% 1/16 • Number of events 1 • 1 year

Additional Information

Dr. Roy H Decker, MD PhD

Yale University

Phone: 203 737-2758

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place