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NCT04420884 · ClinicalTrials.gov registry record · Phase 1
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
A Phase 1 study of Solid Neoplasms, sponsored by Takeda.
- Active
- Registry status
- Phase 1
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT04420884 is a Phase 1 study of Solid Neoplasms that is active but no longer recruiting, run by Takeda. The registered enrollment target is 248 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT04420884, a Phase 1 study of Solid Neoplasms, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG 5-fluorouracil
- DRUG Platinum
- DRUG Dazostinag
Study Locations (20)
Missouri
- Siteman Cancer Center - St. Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Washington University School of Medicine Siteman Cancer Center - St Louis
- Siteman Cancer Center - South County - St Louis
California
- University of California San Diego Moores Cancer Center - La Jolla
- Norris Comprehensive Cancer Center - Los Angeles
- UCI Health - Chao Family Comprehensive Cancer Center - Orange
- University of California Los Angeles - Jonsson Comprehensive Cancer Center - Santa Monica
Ohio
- University of Cincinnati Health Barrett Cancer Center - Cincinnati
- University of Cincinnati Health Barrett Cancer Center - Cincinnati
- West Chester Hospital - West Chester
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- SCRI - HealthOne Denver - Denver
Connecticut
- Yale Cancer Center - New Haven
Florida
- Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology - Gainesville
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04420884
The ClinicalTrials.gov registry entry for NCT04420884 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04420884 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Missouri, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04420884 about?
NCT04420884 is a clinical study titled "A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors". The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two...
What is the current status of trial NCT04420884?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 248 participants. The study started on 2020-07-22. Estimated completion is 2026-03-31.
What conditions does trial NCT04420884 study?
This clinical trial studies the following conditions: Solid Neoplasms.
What interventions are being tested in trial NCT04420884?
The interventions under investigation include: Pembrolizumab (DRUG), 5-fluorouracil (DRUG), Platinum (DRUG), Dazostinag (DRUG).
Who is sponsoring clinical trial NCT04420884?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04420884 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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