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NCT02521844 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours
A Phase 1 study of Solid Tumors, sponsored by EDDC (Experimental Drug Development Centre), A*STAR Research Entities.
- Active
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
- 11
- Study locations
NCT02521844 is a Phase 1 study of Solid Tumors that is active but no longer recruiting, run by EDDC (Experimental Drug Development Centre), A*STAR Research Entities. The registered enrollment target is 89 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (69% lower). The trial reports 11 study locations across 9 states.
The verdict
NCT02521844, a Phase 1 study of Solid Tumors, is active but no longer recruiting, sponsored by EDDC (Experimental Drug Development Centre), A*STAR Research Entities.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
- 11
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG ETC-1922159
Study Locations (11)
Oregon
- Oregon Health and Science University-Knight Cancer Institute, 3485 S Bond Ave., Mail code 0C14CTSite 211 - Portland
- Oregon Health and Science University, 3181 Southwest Sam Jackson Park Road, Mail Code Cr 9-4, Site 211 - Portland
Other
- National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Site 101 - Singapore
- National Cancer Centre Singapore, 11 Hospital Drive, Site 102 - Singapore
Arizona
- University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203 - Tucson
California
- Chao Family Comprehensive Cancer Center,Stern Center for Cancer Clinical Trials and Research, 101 City Drive South, Site 209 - Orange
Colorado
- University of Colorado Hospital Anschutz Cancer Pavilion, 12648 East 17th Avenue; MSF 700, Site 202 - Aurora
Kansas
- University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Suite 2310, MS 6004, Site 210 - Fairway
Missouri
- Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place, Site 205 - St Louis
North Carolina
- Duke University Medical Center, Duke Cancer Center, 20 Duke Medicine Circle, Site 206 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2015-10 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02521844
The ClinicalTrials.gov registry entry for NCT02521844 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (69% lower). The listed sponsor is EDDC (Experimental Drug Development Centre), A*STAR Research Entities, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02521844 reports 11 study locations spanning 9 distinct geographic areas - top geographies include Oregon, Other, Arizona.
Frequently Asked Questions
What is clinical trial NCT02521844 about?
NCT02521844 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours". 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 sol...
What is the current status of trial NCT02521844?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2015-10. Estimated completion is 2024-10-31.
What conditions does trial NCT02521844 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT02521844?
The interventions under investigation include: Pembrolizumab (DRUG), ETC-1922159 (DRUG).
Who is sponsoring clinical trial NCT02521844?
This trial is sponsored by EDDC (Experimental Drug Development Centre), A*STAR Research Entities, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02521844 being conducted?
This trial has 11 study locations across Arizona, California, Colorado, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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