Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Pleural Effusion

Lung Neoplasms

Pleural Effusion, Malignant

Lung Diseases

Pleural Diseases

Pleural Neoplasms

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Dasatinib

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dose escalation followed by dose expansion. Escalation cohort: Afatinib and Dasatinib. This study is divided into two parts. The first 8 - 18 people will be entered in the first part, called Phase 1A. Then this part will end.

Expansion cohort:: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B.

1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg.

Dasatinib - 1A

1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg.

Afatinib - 1A

In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.

Dasatinib - 1B

Afatinib - 1B

Ben Creelan, M.D.

The purpose of this study is to:

* Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer
* Learn how these two drugs work in cancer cells when they are combined
* Learn more about the side effects of these two drugs when combined
* Find the highest doses of the study drugs Afatinib and Dasatinib that can be given safely without causing serious side effects

Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)

Phase I Trial Evaluating Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Afatinib (BIBW 2992) in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Non-small Cell Lung Cancer (NSCLC)

The MTD for this combined treatment will be defined as either:

1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or,
2. Afatinib at the highest tolerated dose investigated (40 mg by mouth \[PO\] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).

Estimates objective response rate (complete response \[CR\] and partial response \[PR\]) in participants with acquired EGFR resistance

Estimate the 6-month progression free survival (PFS) rate in participants with acquired EGFR resistance. Response Criteria for Phase 1B will follow RECIST v.1.1: Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Boehringer Ingelheim

Bristol-Myers Squibb

H. Lee Moffitt Cancer Center and Research Institute

Participants were given 30 mg Afatinib and 100 mg Dasatinib

Part 1A Level 1

Participants were given 40 mg Afatinib and 100 mg Dasatinib

Part 1A Level 2

Participants given Afatinib 30 mg and 100 mg Dasatinib

Part 1B

All Participants Who Received Study Treatment

All Participants

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Thoracic CRO, attn: Dr. Ben Creelan

Dasatinib daily

Dose Escalation and Expansion

All participants who received at least one dose of Afatinib and Dasatinib.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)	NCT01999985	Lung Cancer Non-small Cell ...	Dasatinib - 1A Afatinib - 1A Dasatinib - 1B Afatinib - 1B	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)	NCT01999985	Lung Cancer Non-small Cell ...	Dasatinib - 1A Afatinib - 1A Dasatinib - 1B Afatinib - 1B	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for t790m mutation.