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NCT01577758 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C
A Phase 1 study of Advanced Gastrointestinal Malignancies, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01577758: Completed Phase 1 study of Advanced Gastrointestinal Malignancies, sponsored by Millennium Pharmaceuticals.
NCT01577758 is a Phase 1 study of Advanced Gastrointestinal Malignancies that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01577758, a Phase 1 study of Advanced Gastrointestinal Malignancies, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.
Primary Outcome
DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy. 1. Grade 4 neutropenia (Absolute Neutrophil Count \< 500 cells/mm\^3). 2. Grade 3 or greater neutropenia with fever and/or infection. 3. Grade 4 thrombocytopenia (platelets \< 25,000/mm\^3). 4. Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time. 5. Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis. 6. G
Conditions Studied
Interventions
- DRUG MLN0264
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01577758 record still lists
NCT01577758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Advanced Gastrointestinal Malignancies appearing as the primary indexed condition, and to 1 intervention - of which MLN0264 is the first listed.
NCT01577758 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01577758 about?
NCT01577758 is a clinical study titled "Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C". This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.
What is the current status of trial NCT01577758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2012-06. Estimated completion is 2014-02.
What conditions does trial NCT01577758 study?
This clinical trial studies the following conditions: Advanced Gastrointestinal Malignancies.
What interventions are being tested in trial NCT01577758?
The interventions under investigation include: MLN0264 (DRUG).
Who is sponsoring clinical trial NCT01577758?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01577758 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01577758's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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