Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours
Official Title: A Phase 1A/B Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours
Study ID: NCT02521844
Conditions
Study Description
Brief Summary: This is a Phase 1A/B study consisting of four parts. 1. Part A (completed) is a non-randomised, open-label, sequential evaluation of the safety, pharmacokinetics (PK), maximum tolerated dose (MTD), and recommended dose (RD) of ETC-1922159 in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. Dose escalation, with the goal of identifying the MTD and RD, is guided by an ordinal continual reassessment method (oCRM) model with a cohort size of one patient. 2. Part A extension (completed) is a non-randomised, non-comparative, open-label evaluation of the safety and tolerability of ETC-1922159 together with the bone protective treatment (denosumab) in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. 3. Part B dose escalation (completed) is a non-randomised, open-label, sequential evaluation of the MTD, RD, safety, PK, and PD (pharmacodynamics) of ETC 1922159 in combination with pembrolizumab in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. 4. Part B dose expansion will be a non-randomised, non-comparative, open-label study evaluation of the safety and tolerability of ETC-1922159 as a single agent until disease progression and then in combination with pembrolizumab at the RD identified in the Part B dose escalation segment, in patients with advanced or metastatic, or unresectable solid malignancies that are refractory, intolerant or not suitable for available treatment according to the treating physician. It is anticipated that the study will take approximately 78 months to complete (36 months for Part A and Part A Extension, approximately 6 months for Part B dose escalation and approximately 36 months for Part B dose expansion).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203, Tucson, Arizona, United States
Chao Family Comprehensive Cancer Center,Stern Center for Cancer Clinical Trials and Research, 101 City Drive South, Site 209, Orange, California, United States
University of Colorado Hospital Anschutz Cancer Pavilion, 12648 East 17th Avenue; MSF 700, Site 202, Aurora, Colorado, United States
University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Suite 2310, MS 6004, Site 210, Fairway, Kansas, United States
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place, Site 205, Saint Louis, Missouri, United States
Duke University Medical Center, Duke Cancer Center, 20 Duke Medicine Circle, Site 206, Durham, North Carolina, United States
Oregon Health and Science University-Knight Cancer Institute, 3485 S Bond Ave., Mail code 0C14CTSite 211, Portland, Oregon, United States
Oregon Health and Science University, 3181 Southwest Sam Jackson Park Road, Mail Code Cr 9-4, Site 211, Portland, Oregon, United States
Department of Investigational Cancer Therapeutics, 1400 Holcombe Blvd., Unit 455, Site 201, Houston, Texas, United States
National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Site 101, Singapore, , Singapore
National Cancer Centre Singapore, 11 Hospital Drive, Site 102, Singapore, , Singapore
Contact Details
Name: Venkateshan Srirangam Prativadibhayankara
Affiliation: EDDC, Medical Director
Role: STUDY_DIRECTOR
Name: Karuppan C Palaniappan
Affiliation: PPD, Medical Director
Role: STUDY_DIRECTOR
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