Trial Outcomes & Findings for Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00138203)

Results Overview

Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)

Results posted on

2018-01-30

Participant Flow

Recruitment will occur at all participating sites from August 2005 - June 2007.

Participant milestones

Participant milestones
Measure	SAHA Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAHA n=16 Participants Suberoylanilide Hydroxamic Acid (SAHA)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 16 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	16 participants n=99 Participants

PRIMARY outcome

Timeframe: Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)

Population: Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.

Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.

Outcome measures

Outcome measures
Measure	SAHA n=14 Participants Suberoylanilide Hydroxamic Acid (SAHA)
Response Per RECIST Criteria	0 participants

SECONDARY outcome

Timeframe: From start of treatment to progression (average was 3.7 months)

Population: Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.

Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.

Outcome measures

Outcome measures
Measure	SAHA n=14 Participants Suberoylanilide Hydroxamic Acid (SAHA)
Time to Progression	2.3 months Interval 0.9 to 19.4

SECONDARY outcome

Timeframe: From treatment start to time of death

Population: All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation

Overall survial of subjects from the start of treatment to the time of death

Outcome measures

Outcome measures
Measure	SAHA n=14 Participants Suberoylanilide Hydroxamic Acid (SAHA)
Overall Survial	7.1 months Interval 1.4 to 30.0

SECONDARY outcome

Timeframe: From first dose of treatment until 30 days from the last dose of treatment

Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.

Outcome measures

Outcome measures
Measure	SAHA n=16 Participants Suberoylanilide Hydroxamic Acid (SAHA)
Toxicity	16 Participants

Adverse Events

SAHA

Serious events: 9 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SAHA n=16 participants at risk Suberoylanilide Hydroxamic Acid (SAHA)
Vascular disorders Thrombosis	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy
Vascular disorders Cerebrovascular accident	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy
Skin and subcutaneous tissue disorders Neutropenia	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy
Vascular disorders Pulmonary embolism	12.5% 2/16 • Number of events 2 • From the time subjects started therapy until 30 days after they completed therapy
Blood and lymphatic system disorders Neutropenia	12.5% 2/16 • Number of events 2 • From the time subjects started therapy until 30 days after they completed therapy
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy
Endocrine disorders Hyperglycemia	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy

Other adverse events

Other adverse events
Measure	SAHA n=16 participants at risk Suberoylanilide Hydroxamic Acid (SAHA)
Respiratory, thoracic and mediastinal disorders Pnemonia	6.2% 1/16 • Number of events 1 • From the time subjects started therapy until 30 days after they completed therapy
Blood and lymphatic system disorders Lymphopenia	18.8% 3/16 • Number of events 3 • From the time subjects started therapy until 30 days after they completed therapy
Endocrine disorders Hyperglycemia	31.2% 5/16 • Number of events 5 • From the time subjects started therapy until 30 days after they completed therapy
General disorders Fatigue	25.0% 4/16 • Number of events 4 • From the time subjects started therapy until 30 days after they completed therapy
Blood and lymphatic system disorders Neutropenia	37.5% 6/16 • Number of events 6 • From the time subjects started therapy until 30 days after they completed therapy

Additional Information

Dr. Anne Traynor

University of Wisconsin Carbone Cancer Center

Phone: (608) 262-8158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60