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NCT03449030 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03449030: Clinical Trial Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT03449030 is a Phase 1 study that was terminated before completion, run by Millennium Pharmaceuticals. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449030, a Phase 1 study, was terminated before completion, sponsored by Millennium Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
Primary Outcome
DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count \[ANC\] less than (\<) 500 cells/cubic millimeter \[mm\^3\]), thrombocytopenia (platelets \<25,000/mm\^3), febrile neutropenia (ANC \<100
Interventions
- DRUG TAK-164
- DRUG 89Zr-TAK-164
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 1 |
Why NCT03449030 stopped before completion
NCT03449030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-164 is the first listed.
NCT03449030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03449030 about?
NCT03449030 is a clinical study titled "A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)". The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
What is the current status of trial NCT03449030?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2018-04-23. Estimated completion is 2020-02-27.
What interventions are being tested in trial NCT03449030?
The interventions under investigation include: TAK-164 (DRUG), 89Zr-TAK-164 (DRUG).
Who is sponsoring clinical trial NCT03449030?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03449030's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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