Dasatinib in Advanced Squamous Cell Lung Cancer
Primary Purpose
Squamous Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dasatinib
Sponsored by

About this trial
This is an interventional treatment trial for Squamous Cell Lung Cancer focused on measuring Lung cancer, NSCLC, Stage IIIB, Stage IV
Eligibility Criteria
Inclusion Criteria:
- Stage III/B or IV squamous NSCLC
- Measurable disease
- Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
- ECOG performance status of 0 or 1
- Estimated life expectancy greater than 12 weeks
- Normal organ and marrow function
- Confirmed availability of archival pathology samples
- Agrees to discontinue St. Johns Wort
- Able to take medications by mouth
- Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug
Exclusion Criteria:
- Pregnant or breast-feeding
- Chemotherapy or radiotherapy within 4 weeks prior to entering study
- Receiving any other investigational agents
- Known untreated or progressive brain metastases
- History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
- Taking medications known to be potent CYP3A4 inhibitors
- Currently taking H2 inhibitors or proton pump inhibitors
- Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
- HIV positive
- Clinically uncontrolled hypertension (blood pressure > 160/110)
- Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
- Active and uncontrolled clinically significant infection
- Chronic gastrointestinal disease
- Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
- Supplemental oxygen required for current malignancy
- Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
- Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasatinib
Arm Description
Dasatinib 140 mg by mouth each day
Outcomes
Primary Outcome Measures
Response Rate
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
Secondary Outcome Measures
Types and Frequency of DDR2 Mutations
Determine frequency of DDR2 mutations in study patients
Survival
Establish the overall survival of patients with SCC treated with dasatinib
Toxicities
Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.
Full Information
NCT ID
NCT01491633
First Posted
October 5, 2011
Last Updated
June 14, 2014
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01491633
Brief Title
Dasatinib in Advanced Squamous Cell Lung Cancer
Official Title
Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Safety issues/concerns per DF/HCC PI
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.
Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.
An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.
Detailed Description
Dasatinib will be taken orally, daily in cycles of 28 days.
On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:
Medical history and clinical exam
Safety blood tests
Measurement of Performance Status
Review of pill log
CT scans will be done every 8 weeks.
In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.
Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Lung Cancer
Keywords
Lung cancer, NSCLC, Stage IIIB, Stage IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
Dasatinib 140 mg by mouth each day
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Description
140 mg orally, daily in 28 day cycles
Primary Outcome Measure Information:
Title
Response Rate
Description
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Types and Frequency of DDR2 Mutations
Description
Determine frequency of DDR2 mutations in study patients
Time Frame
2 years
Title
Survival
Description
Establish the overall survival of patients with SCC treated with dasatinib
Time Frame
2 years
Title
Toxicities
Description
Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III/B or IV squamous NSCLC
Measurable disease
Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
ECOG performance status of 0 or 1
Estimated life expectancy greater than 12 weeks
Normal organ and marrow function
Confirmed availability of archival pathology samples
Agrees to discontinue St. Johns Wort
Able to take medications by mouth
Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug
Exclusion Criteria:
Pregnant or breast-feeding
Chemotherapy or radiotherapy within 4 weeks prior to entering study
Receiving any other investigational agents
Known untreated or progressive brain metastases
History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
Taking medications known to be potent CYP3A4 inhibitors
Currently taking H2 inhibitors or proton pump inhibitors
Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
HIV positive
Clinically uncontrolled hypertension (blood pressure > 160/110)
Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
Active and uncontrolled clinically significant infection
Chronic gastrointestinal disease
Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
Supplemental oxygen required for current malignancy
Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Johnson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24128713
Citation
Brunner AM, Costa DB, Heist RS, Garcia E, Lindeman NI, Sholl LM, Oxnard GR, Johnson BE, Hammerman PS. Treatment-related toxicities in a phase II trial of dasatinib in patients with squamous cell carcinoma of the lung. J Thorac Oncol. 2013 Nov;8(11):1434-7. doi: 10.1097/JTO.0b013e3182a47162.
Results Reference
result
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Dasatinib in Advanced Squamous Cell Lung Cancer
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