Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02223819|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2014
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: Crizotinib||Phase 2|
Uveal melanoma is the most common primary intraocular malignancy in adults, and arises from melanocytes within the choroid plexus of the eye. Melanomas of the ocular and adnexal structures comprise approximately 5% of all melanomas and are biologically and prognostically distinct from cutaneous melanoma. In the United States, an estimated 2000 patients are diagnosed with this disease each year.
The development of metastasis in this disease is common and occurs in approximately 50% of patients with posterior uveal melanoma within 15 years after the initial diagnosis and treatment. Uveal melanoma is thought to be particularly resistant to systemic treatment, and no systemic therapy has yet been demonstrated to improve survival. Drugs commonly used to treat advanced cutaneous melanoma rarely achieve durable responses in patients with uveal melanoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Adjuvant Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration.
Other Name: Xalkori
- Relapse Free Survival (RFS) rate [ Time Frame: Up to 36 months ]RFS rate will be defined as the percentage of patients who do not experience any new tumor growth at any site on the body distant from the primary site or death from any cause from the time of study entry to the end of the relevant timepoint.
- Overall Survival (OS) rate [ Time Frame: Up to 36 months ]OS will be defined as the time from treatment start to date of death or last followup and estimated using Kaplan-Meier methodology.
- Disease-Specific Survival (DSS) time [ Time Frame: Up to 36 months ]DSS is defined as the time from treatment start to death due to disease or last followup.
- Prevalence of treatment discontinuation due to toxicity [ Time Frame: 48 weeks ]Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.
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): NCT02223819
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|United States, New York|
|Columbia Univeristy Medical Center|
|New York, New York, United States, 10032|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Richard Carvajal, MD||Associate Professor of Medicine at the Columbia University Medical Center|