Vandetanib in Advanced NSCLC With RET Rearrangement
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|ClinicalTrials.gov Identifier: NCT01823068|
Recruitment Status : Unknown
Verified April 2016 by Se-Hoon Lee, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : April 4, 2013
Last Update Posted : April 20, 2016
The purpose of this study is to investigate the efficacy and safety of vandetanib, in patients with advanced non-small-cell lung cancer harboring RET gene rearrangement. In 2011, gene rearrangement between RET and KIF5B gene (fusion) was discovered in a young, male lung cancer patient. The following studies showed that this gene rearrangement was critical for tumor initiation and maintenance. Of note, the growth and signaling properties mediated by KIF5B-RET were diminished after treatment with vandetanib.
Until now, RET rearrangements have been known in thyroid cancers. Vandetanib, a multi-kinase inhibitors with anti-RET activity, is an FDA-approved drug for the treatments of adults with metastatic medullary thyroid cancers who are ineligible for surgery and who have progressive or symptomatic disease. This study aimed to examine the efficacy and safety of this drug, for the treatment of advanced lung cancer harboring RET rearrangement.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Vandetanib||Phase 2|
Patients will be screened so as to confirm RET fusion in their tumor tissue. RET fusion will be tested using fluorescence in situ hybridization (FISH) at central laboratory. Central laboratory of this study is the department of pathology at Seoul National University Hospital (SNUH) and tumor specimen should be sent to department of pathology at SNUH. Only patients whose tumor have confirmed RET gene fusion are eligible for this study.
Enrolled patients will begin on once daily vandetanib at 300 mg with one cycle of 4 weeks. Renal-impaired patients (defined as patients with creatinine clearance ≥30 to <50 mL/min at screening) will start treatment at the lower dose of 200 mg. Treatment will be continued till progression, unacceptable toxicity, or till 1 year. Vandetanib can be administered after 1 year to the patients with benefit from vandetanib.
During the administration of vandetanib, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, ECG, adverse events and concomitant drugs will be evaluated every four weeks (one cycle, for the first 6 months) or eight weeks (two cycles, from 6 months to 1 year) and, if necessary, chest X-ray and pregnancy test will also be performed. CT for tumor assessment will be performed once every 8 weeks for 1 year. If the disease progression is suspected, the test can be additionally conducted at the investigator's discretion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Vandetanib in Patients With Non-small Cell Lung Cancer Harboring RET Rearrangement|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Vandetanib treatment arm
Vandetanib 300 mg once daily orally
Patients will begin on once daily vandetanib at 300 mg with one cycle of 4 weeks.
Other Name: Caprelsa
- Objective response rate (ORR) [ Time Frame: 1 year ]ORR will be evaluated through the frequency analysis with 95% confidence interval.
- Progression-free survival (PFS) [ Time Frame: 1 year ]PFS will be examined with Kaplan-Meier method.
- Disease-control rate (DCR) [ Time Frame: 1 year ]DCR will be evaluated through the frequency analysis with 95% confidence interval.
- Overall survival (OS) [ Time Frame: 2 years ]OS will be examined with Kaplan-Meier method.
- Number of Participants with Adverse Events [ Time Frame: 1 years ]Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823068
|Contact: Se-Hoon Lee, MD, PhDemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110744|
|Principal Investigator: Se-Hoon Lee, M.D., Ph.D.|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135710|
|Principal Investigator: Myung-Ju Ahn, M.D.|