Spots Global Cancer Trial Database for A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
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Trial Identification
Brief Title: A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
Official Title: A Multi-part, Phase 1, Multi-center, Open-label Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel or Pembrolizumab in Patients With Relapsed or Refractory Esophagogastric Malignancies
Study ID: NCT02013154
Study Description
Brief Summary: A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies
Detailed Description: This is a dose-escalating, open-label study conducted in multiple parts (Part A dose-escalation, Parts B-F expansion cohorts, and a monotherapy substudy). Parts A-E (DKN-01 plus paclitaxel) and the DKN-01 monotherapy substudy includes 28-day cycle treatment cycles; Part F (DKN-01 plus pembrolizumab) includes 21-day treatment cycles. Depending on their cancer type, subjects with histologically confirmed recurrent or refractory esophageal, gastro-esophageal junction tumors, or gastric adenocarcinoma will be enrolled in each study part to receive DKN-01 150 mg or 300 mg in combination with paclitaxel or pembrolizumab. Subjects who are unable to receive paclitaxel or pembrolizumab for any reason are allowed to receive single agent DKN-01 300 mg as part of a monotherapy substudy. Results are reported by treatment group, irrespective of the study part in which the subject was enrolled.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars Sinai Medical Care Foundation, Los Angeles, California, United States
Smilow Cancer Hospital at Yale - New Haven, New Haven, Connecticut, United States
Northwestern University, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Duke University, Durham, North Carolina, United States
Tennessee Oncology / Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University / VICC, Nashville, Tennessee, United States
Mary Crowley Cancer Center, Dallas, Texas, United States
CTRC @ The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: Cyndi Sirard, MD
Affiliation: Leap Therapeutics, Inc.
Role: STUDY_DIRECTOR
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