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NCT02551055 · ClinicalTrials.gov registry record · Phase 1
MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02551055: Clinical Trial Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT02551055 is a Phase 1 study that was terminated before completion, run by Millennium Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02551055, a Phase 1 study, was terminated before completion, sponsored by Millennium Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part 2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel, investigational TAK-659 or investigational alisertib in adult participants with advanced and metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose escalation phase (Part 1) and a dose expansion phase (Part 2).
Primary Outcome
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of following considered related to any of treatment by investigator: Grade 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>7 days; ≥ Grade 3 neutropenia with coincident fever or infection; Grade 4 thrombocytopenia for \>7 days; Grade 3 thrombocytopenia with clinically significant bleeding; Platelet count \<10,000/mm\^3 at any time; Delay in
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Alisertib
- DRUG TAK-659
- DRUG MLN1117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-10-15 |
| Est. Completion | 2017-02-17 |
| Phase | Phase 1 |
Why NCT02551055 stopped before completion
NCT02551055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT02551055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02551055 about?
NCT02551055 is a clinical study titled "MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma". The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part 2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel, investigational TAK-659 or investigational alisertib in adult participants with advanced and metastatic gastric or...
What is the current status of trial NCT02551055?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-10-15. Estimated completion is 2017-02-17.
What interventions are being tested in trial NCT02551055?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Alisertib (DRUG), TAK-659 (DRUG), MLN1117 (DRUG).
Who is sponsoring clinical trial NCT02551055?
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 NCT02551055's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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