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Spots Global Cancer Trial Database for A Study of LY2801653 in Advanced Cancer

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Trial Identification

Brief Title: A Study of LY2801653 in Advanced Cancer

Official Title: A Phase 1 Study of LY2801653 in Patients With Advanced Cancer

Study ID: NCT01285037

Conditions

Cancer

Study Description

Brief Summary: Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653. Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma. Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin. Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus cisplatin. Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with gastric cancer when taken with ramucirumab.

Detailed Description: Parts C and D were added to the registration in November, 2013, per protocol amendment. Parts E and F were added to the registration in February, 2015, per protocol amendment.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Cancer Center, Tucson, Arizona, United States

Georgetown University Medical Center, Washington, District of Columbia, United States

Mount Sinai Medical Center, New York, New York, United States

University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Contact Details

Name: Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5hours, EST)

Affiliation: Eli Lilly and Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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