CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Dasatinib - 1A +3 moredrug
Likely dose
Dasatinib - 1A 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01999985
NCT01999985Phase 1Completed
CompareCT.gov

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)

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 3, 2013·Updated Nov 27, 2020

In Brief

A Phase 1 clinical trial evaluating Dasatinib - 1A, Afatinib - 1A, and 2 other interventions for Lung Cancer and Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 25 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Non-small Cell Lung Cancer (NSCLC)
CountriesUnited States
CollaboratorsBoehringer Ingelheim, Bristol-Myers Squibb

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 3, 2013
Enrollment StartDec 31, 2013
Primary CompletionMar 21, 2017
Study CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.6 years ago

Interventions

Dasatinib - 1Adrug

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

Afatinib - 1Adrug

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

Dasatinib - 1Bdrug

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.

Afatinib - 1Bdrug

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.