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

NCT01999985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-11-27

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ben Creelan, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-03-21
Completion
2019-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999985 on ClinicalTrials.gov