Trial Outcomes & Findings for Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib (NCT NCT00570401)

Last Updated: 2016-01-22

Results Overview

To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Dasatinib Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Overall Study Adverse Event	2

Baseline Characteristics

Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=21 Participants Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Dasatinib n=19 Participants Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Determine the Overall Objective Response Stable Disease (SD)	6 participants
Determine the Overall Objective Response Progression of Disease (POD)	13 participants

Adverse Events

Dasatinib

Serious events: 12 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=21 participants at risk Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Gastrointestinal disorders Constipation	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 7/21 • Number of events 7
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Number of events 1
Infections and infestations Infection	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Small intestinal obstruction	4.8% 1/21 • Number of events 1
General disorders Back pain	4.8% 1/21 • Number of events 1
General disorders Pleuritic pain	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Thrombosis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1

Other adverse events

Other adverse events
Measure	Dasatinib n=21 participants at risk Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
Metabolism and nutrition disorders Albumin, low (hypoalbuminemia)	23.8% 5/21 • Number of events 5
Metabolism and nutrition disorders Alkaline phosphatase	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders ALT, SGPT	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Constipation	14.3% 3/21 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	14.3% 3/21 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	38.1% 8/21 • Number of events 8
General disorders Fatigue (asthenia, lethargy, malaise)	42.9% 9/21 • Number of events 9
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	19.0% 4/21 • Number of events 4
Blood and lymphatic system disorders Hemoglobin	19.0% 4/21 • Number of events 4
Blood and lymphatic system disorders Leukocytes (total WBC)	14.3% 3/21 • Number of events 3
Blood and lymphatic system disorders Lymphopenia	19.0% 4/21 • Number of events 4
Gastrointestinal disorders Nausea	9.5% 2/21 • Number of events 2
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Potassium, high (hyperkalemia)	9.5% 2/21 • Number of events 2

Additional Information

Dr. Gregory Riely

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place