NCT01999985

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Dasatinib - 1A	1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg.
DRUG	Afatinib - 1A	1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg.
DRUG	Dasatinib - 1B	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.
DRUG	Afatinib - 1B	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.

Timeline

• Start date: 2013-12-31
• Primary completion: 2017-03-21
• Completion: 2019-05-30
• First posted: 2013-12-03
• Last updated: 2020-11-27
• Results posted: 2019-06-14

Locations

1 site across 1 country: United States