Trial Outcomes & Findings for Dasatinib in Advanced Squamous Cell Lung Cancer (NCT NCT01491633)

NCT ID: NCT01491633

Last Updated: 2014-07-15

Results Overview

Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2014-07-15

Participant Flow

Participant milestones

Measure	Dasatinib Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Advanced Squamous Cell Lung Cancer

Baseline characteristics by cohort

Measure	Dasatinib n=5 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib

Outcome measures

Measure	Dasatinib n=5 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Response Rate	NA percent No subjects were evaluable for response

SECONDARY outcome

Timeframe: 2 years

Determine frequency of DDR2 mutations in study patients

Outcome measures

Measure	Dasatinib n=5 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Types and Frequency of DDR2 Mutations	0 participants

SECONDARY outcome

Timeframe: 2 years

Population: One subject who was alive at the end of the study was censored from the survival analysis

Establish the overall survival of patients with SCC treated with dasatinib

Outcome measures

Measure	Dasatinib n=4 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Survival	112 days Standard Deviation 85

SECONDARY outcome

Timeframe: 2 years

Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.

Outcome measures

Measure	Dasatinib n=5 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Toxicities	3 grade 3 toxicities

POST_HOC outcome

Timeframe: 2 years

Number of days participant remained on study

Outcome measures

Measure	Dasatinib n=5 Participants Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Time on Study	22 days Standard Deviation 12

Adverse Events

Dasatinib

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dasatinib n=5 participants at risk Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Respiratory, thoracic and mediastinal disorders Hemoptysis	20.0% 1/5 • Number of events 1
General disorders Death	20.0% 1/5 • Number of events 1

Other adverse events

Measure	Dasatinib n=5 participants at risk Dasatinib 140 mg by mouth each day Dasatinib: 140 mg orally, daily in 28 day cycles
Respiratory, thoracic and mediastinal disorders Pleural effusion	40.0% 2/5 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1
General disorders Fatigue	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Elevated LFTs	20.0% 1/5 • Number of events 1
General disorders Anorexia	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1

Additional Information

Dr. Peter Hammerman

Dana-Farber Cancer Institute

Phone: 617-632-3000

Email: phammerman@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place