Squamous Cell Lung CancerPhase 2NCT01491633
Dasatinib in Advanced Squamous Cell Lung Cancer
A Phase 2 study testing Dasatinib in people with Squamous Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer
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.
Read the 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.
- Conditions
- Squamous Cell Lung Cancer
- Being tested
- Dasatinib
- Keywords
- Lung cancer, NSCLC, Stage IIIB, Stage IV
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-354825
140 mg orally, daily in 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib 140 mg by mouth each day Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
Measured: 2 years
Secondary outcomes (3)
Types and Frequency of DDR2 Mutations
Determine frequency of DDR2 mutations in study patients
Measured: 2 years
Survival
Establish the overall survival of patients with SCC treated with dasatinib
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionMay 2013
Why it stopped: Safety issues/concerns per DF/HCC PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Johnson, MD, Dana-Farber Cancer Institute
- Investigators
- Bruce Johnson, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491633
- Sponsor's protocol ID
- 11-142
- Status last verified
- Jun 2014
- First submitted
- 5 Oct 2011
- Last updated
- 15 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24128713
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01491633
- Acronym / sponsor ID
- 11-142
- Conditions
- Squamous Cell Lung Cancer
- Keywords
- Lung cancer, NSCLC, Stage IIIB, Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issues/concerns per DF/HCC PI
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Posted 15 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: DasatinibDasatinib 140 mg by mouth each day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: BMS-354825140 mg orally, daily in 28 day cycles | Drug | Dasatinib |
Primary outcome
Response Rate
Time frame: 2 years
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
3 secondary outcomes
Types and Frequency of DDR2 Mutations
Time frame: 2 years
Survival
Time frame: 2 years
Toxicities
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24128713Brunner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Johnson, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Squamous Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01491633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.