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NCT02393209 · ClinicalTrials.gov registry record · Phase 1
Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02393209: Clinical Trial Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT02393209 is a Phase 1 study that was terminated before completion, run by Millennium Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02393209, a Phase 1 study, was terminated before completion, sponsored by Millennium Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when administered in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and in combination with docetaxel at the RP2D in participants with locally advanced or metastatic non-small cell lung cancer.
Primary Outcome
DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count \<10,000/mm\^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥
Interventions
- DRUG Docetaxel
- DRUG TAK-117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 1 |
Why NCT02393209 stopped before completion
NCT02393209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT02393209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02393209 about?
NCT02393209 is a clinical study titled "Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer". The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when administered in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and in combination with do...
What is the current status of trial NCT02393209?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-06-03. Estimated completion is 2017-01-20.
What interventions are being tested in trial NCT02393209?
The interventions under investigation include: Docetaxel (DRUG), TAK-117 (DRUG).
Who is sponsoring clinical trial NCT02393209?
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 NCT02393209's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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