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NCT04725994 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
A Phase 1 study of Gastric Cancer, sponsored by Idience Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 14
- Study locations
NCT04725994: Recruiting Phase 1 study of Gastric Cancer, sponsored by Idience Co..
NCT04725994 is a Phase 1 study of Gastric Cancer that is actively recruiting participants, run by Idience Co.. The registered enrollment target is 100 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (69% lower). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725994, a Phase 1 study of Gastric Cancer, is actively recruiting participants, sponsored by Idience Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
Primary Outcome
To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined.
Conditions Studied
Interventions
- DRUG IDX-1197+XELOX
- DRUG IDX-1197+Irinotecan
Study Locations (14)
Other
- Beijing Cancer Hospital - Beijing
- The Sixth Affiliated Hospital of Sun Yat-Sen University - Guangzhou
- Shanghai East Hospital - Shanghai
- Dong-A University Hospital - Busan
- Seoul National University Bundang Hospital - Seongnam
- Korea University Anam Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- Seoul National University Hospital - Seoul
- Severance Hospital - Yonsei Cancer Center - Seoul
California
- USC Norris Comp. Cancer Ctr Hospital - Los Angeles
Louisiana
- Hematology Oncology Clinic Baton Rouge / Sarah Cannon - Baton Rouge
Massachusetts
- Dana Farber Cancer Institute - Boston
New Jersey
- Astera Cancer Care - East Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT04725994 shows while recruiting
NCT04725994 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions - of which IDX-1197+XELOX is the first listed.
NCT04725994 lists 14 locations in 5 states (Other, California, Louisiana).
Frequently Asked Questions
What is clinical trial NCT04725994 about?
NCT04725994 is a clinical study titled "Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer". This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
What is the current status of trial NCT04725994?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2021-06-28. Estimated completion is 2026-06-30.
What conditions does trial NCT04725994 study?
This clinical trial studies the following conditions: Gastric Cancer.
What interventions are being tested in trial NCT04725994?
The interventions under investigation include: IDX-1197+XELOX (DRUG), IDX-1197+Irinotecan (DRUG).
Who is sponsoring clinical trial NCT04725994?
This trial is sponsored by Idience Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04725994 being conducted?
This trial has 14 study locations across California, Louisiana, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04725994's enrollment target sits among peer trials
100 88th of 153 higher than 65 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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