Trial Outcomes & Findings for Dasatinib in Advanced Non-small Cell Lung Cancer (NSCL) With Ex Vivo and In Vivo Assessment of Tumor Target Modulation (NCT NCT00858403)

Last Updated: 2014-01-15

Results Overview

We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

1 year, 4 months

Results posted on

2014-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment With Dasatinib
Overall Study STARTED	7
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment With Dasatinib
Overall Study Withdrawal by Subject	1
Overall Study Death	3
Overall Study Disease Progression	1

Baseline Characteristics

Dasatinib in Advanced Non-small Cell Lung Cancer (NSCL) With Ex Vivo and In Vivo Assessment of Tumor Target Modulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Dasatinib n=7 Participants
Age, Customized Between 40 and 49 years	1 participants n=5 Participants
Age, Customized Between 60 and 69 years	4 participants n=5 Participants
Age, Customized Between 70 and 79 years	2 participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year, 4 months

Population: The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.

We planned to estimate the single agent response rate to dasatinib in this patient population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: We were able to assess 4 of the 7 participants at 6 months.

We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.

Outcome measures

Outcome measures
Measure	Treatment With Dasatinib n=4 Participants
Number of Participants With Progression Free Survival (PFS) at 6 Months	1 Participants

SECONDARY outcome

Timeframe: 1 year, 4 months

We evaluated toxicity of dasatinib in this patient population.

Outcome measures

Outcome measures
Measure	Treatment With Dasatinib n=7 Participants
Number of Participants With Serious Adverse Events (SAEs)	3 Participants

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.

We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.

We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.

To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.

Outcome measures

Outcome data not reported

Adverse Events

Treatment With Dasatinib

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment With Dasatinib n=7 participants at risk
Renal and urinary disorders Acute Renal Failure	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Cardiac disorders Cardiac ischemia/infarction	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Death Due to Disease Progression	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Fever in absence of neutropenia	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.

Other adverse events

Other adverse events
Measure	Treatment With Dasatinib n=7 participants at risk
General disorders Abdomen Pain	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Back Pain	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Eye disorders Blurred Vision	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Renal and urinary disorders Creatinine	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Gastrointestinal disorders Dehydration	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Dizziness	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Dyspnea - With Exertion	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Renal and urinary disorders Dysuria	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Blood and lymphatic system disorders Edema - Limb	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Fever	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Headaches	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Blood and lymphatic system disorders Hemoglobin - Anemia	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Hemorrhage - Hemoptysis	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Insomnia	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Nausea - Intermittent	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Gastrointestinal disorders Nausea - Intermittent	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Respiratory, thoracic and mediastinal disorders Pleural Effusion - Intermittent	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
General disorders Voice Hoarseness	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.
Gastrointestinal disorders Vomiting - Intermittent	14.3% 1/7 • Number of events 1 • 1 year, 4 months From first participant on study date to last participant off study date.

Additional Information

Eric Haura, M.D., via Moffitt Cancer Center

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-6827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place