Trials Sponsors Conditions Drugs Pricing

Conditions

Lung Cancer Non-small Cell Lung Cancer (NSCLC)

Keywords

Epidermal Growth Factor Receptor (EGFR)Tyrosine kinase inhibitorsNeoplasmsLung DiseasesRespiratory Tract DiseasesPleural DiseasesPleural NeoplasmsLung NeoplasmsPleural EffusionPleural Effusion, MalignantRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteEGFR mutationAfatinibDasatinibCarcinoma, BronchogenicGene MutationT790M mutation.Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Maximum Tolerated Dose (MTD) of Afatinib (BIBW 2992) in Combination With Dasatinib
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).
Up to 6 Months

Secondary Outcomes (2)

Number of Participants With Objective Response
Up to 6 Months
Median Progression Free Survival
Up to 6 Months

Study Arms (1)

Dose Escalation and Dose Expansion

EXPERIMENTAL

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.

Drug: Dasatinib - 1ADrug: Afatinib - 1ADrug: Dasatinib - 1BDrug: Afatinib - 1B

Interventions

Dasatinib - 1ADrug

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

Also known as: SPRYCEL®, BMS-354825, tyrosine kinase inhibitor, SRC Kinase Inhibitor

Dose Escalation and Dose Expansion

Afatinib - 1ADrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Pathologically or cytologically documented Stage IIIB/IV non-small cell lung cancer, or unresectable recurrent disease following locoregional treatment.
For Phase 1B Extension Only:

Sponsors & Collaborators

H. Lee Moffitt Cancer Center and Research Institute
Otherlead
Bristol-Myers Squibb
Industrycollaborator
Boehringer Ingelheim

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasmsLung DiseasesRespiratory Tract DiseasesPleural DiseasesPleural NeoplasmsPleural EffusionPleural Effusion, MalignantRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteCarcinoma, Bronchogenic

Interventions

DasatinibTyrosine Kinase InhibitorsAfatinib

Results Point of Contact

Title: Thoracic CRO, attn: Dr. Ben Creelan
Organization: H. Lee Moffitt Cancer Center and Research Institute

Study Officials

Ben Creelan, M.D.
H. Lee Moffitt Cancer Center and Research Institute
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

December 31, 2013

Actual (reported)

Primary Completion

You may not qualify if:

Have previously completed or withdrawn from this study or any other study investigating dasatinib. Prior treatment with other tyrosine kinases, including afatinib, is acceptable.
Prior recent systemic or investigational therapy within 21 days of initiation of study treatment. An exception is that epidermal growth factor receptor (EGFR) inhibitor may be continued up until 3 days of initiation of study treatment.
Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment.
Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis and no longer require corticosteroids.
Patients with disease progression in the central nervous system (CNS) only.
Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the principal investigator).
Uncorrected severe electrolyte disorder, including severe potassium (\<3.0 mEq/L) or magnesium ( \< 1.0 mEq/L) deficiency.
Any gastrointestinal disorder with diarrhea as a major symptom, such as Crohn's, or pre-existing chronic diarrhea Common Toxicity Criteria (CTC) Grade ≥ 2 of any etiology. Included are malabsorption disorders that in the opinion of the study physician may affect absorption of either afatinib or dasatinib.
Prior major surgery or radiation therapy within 14 days of initiation of treatment.
Electrocardiogram (ECG) abnormalities indicative of arrhythmia (at the discretion of the investigator).
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to enrollment.
Baseline (\< 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram.
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, congenital long QT syndrome, or Torsades de pointes).
Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec for men and \>480 msec for women per American College of Cardiology/American Heart Association \[AHA/ACC\] 2011 scientific statement).
History of significant bleeding disorder unrelated to cancer, including diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
+7 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Dose Escalation and Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Dose Escalation and Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations