Status:
COMPLETED
Sunitinib in Never-Smokers With Lung Adenocarcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" m...
Detailed Description
Primary Objectives \- To evaluate the objective response rate (ORR) to sunitinib in never-smokers with lung cancers that are wild-type for EGFR, KRAS, and ALK in a single-arm phase II trial Secondar...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer
- Adenocarcinoma histology of any variant, including adenosquamous histology
- Wild-type for mutations in EGFR, KRAS and ALK
- Must have \< 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol
- Disease must be measureable per RECIST 1.1
- At least one prior systemic therapy (adjuvant or palliative)
- 18 years or older
- Life expectancy of greater than 4 weeks
- Adequate ECOG performance status 0 or 1
- Adequate organ function as defined in the protocol
- Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue
Exclusion
- Pregnant or breastfeeding
- Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier
- Radiation therapy within 2 weeks prior to entering study
- Major surgery within 4 weeks prior to entering the study
- Receiving any other investigational agents
- Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
- Use of certain inhibitors and inducers of CYP3A4
- Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry
- History of significant bleeding disorder unrelated to cancer
- Poorly controlled hypertension
- Severe cardiovascular disease
- Prolongation of corrected QT interval
- History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer
- HIV positive on combination antiretroviral therapy
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01829217
Start Date
May 1 2013
End Date
January 1 2018
Last Update
October 31 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
2
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215