A Phase 2 interventional study of Dasatinib in Squamous Cell Lung Cancer, sponsored by Dana-Farber Cancer Institute. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-15.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
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.
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:
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Exclusion Criteria:
Dasatinib 140 mg by mouth each day
Drug: Dasatinib
140 mg orally, daily in 28 day cycles
Also known as: BMS-354825
Response Rate
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
Time frame: 2 years
Types and Frequency of DDR2 Mutations
Determine frequency of DDR2 mutations in study patients
Time frame: 2 years
Survival
Establish the overall survival of patients with SCC treated with dasatinib
Time frame: 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.
Time frame: 2 years
| Milestone | Dasatinib |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib
| percent | Dasatinib |
|---|---|
| Response Rate | NA |
Determine frequency of DDR2 mutations in study patients
| participants | Dasatinib |
|---|---|
| Types and Frequency of DDR2 Mutations | 0 |
Establish the overall survival of patients with SCC treated with dasatinib
| days | Dasatinib |
|---|---|
| Survival | 112 ± 85 |
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.
| grade 3 toxicities | Dasatinib |
|---|---|
| Toxicities | 3 |
Number of days participant remained on study
| days | Dasatinib |
|---|---|
| Time on Study | 22 ± 12 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dasatinib | — | 2/5 (40%) | 5/5 (100%) |
| Event | Dasatinib |
|---|---|
| HemoptysisRespiratory, thoracic and mediastinal disorders | 1/5 |
| DeathGeneral disorders | 1/5 |
| Event | Dasatinib |
|---|---|
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/5 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/5 |
| FatigueGeneral disorders | 1/5 |
| Elevated LFTsGastrointestinal disorders | 1/5 |
| AnorexiaGeneral disorders | 1/5 |
| NauseaGastrointestinal disorders | 1/5 |
| Age, Continuous(years) | Dasatinib |
|---|---|
| Mean | 59 (55 to 78) |
| Sex: Female, Male(Participants) | Dasatinib |
|---|---|
| Female | 2 |
| Male | 3 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dasatinib
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