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NCT02575339 · ClinicalTrials.gov registry record · Phase 1
MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma
A Phase 1 study, sponsored by Kathy Miller.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02575339: Clinical Trial Phase 1 study, sponsored by Kathy Miller.
NCT02575339 is a Phase 1 study that was terminated before completion, run by Kathy Miller. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02575339, a Phase 1 study, was terminated before completion, sponsored by Kathy Miller.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses. Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or the sorafenib arm.
Primary Outcome
The primary objective for phase I of this study is to determine the maximum tolerated dose (MTD) of MLN0128. Maximum Tolerated Dose is defined as the dose level at which fewer than 33% of subjects experience a dose limiting toxicity (DLT).
Interventions
- DRUG Sorafenib
- DRUG MLN0128
- DRUG MLN0128 (RP2D)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-07-18 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 1 |
Why NCT02575339 stopped before completion
NCT02575339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Sorafenib is the first listed.
NCT02575339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02575339 about?
NCT02575339 is a clinical study titled "MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma". This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses. Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or the sorafenib arm.
What is the current status of trial NCT02575339?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-07-18. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT02575339?
The interventions under investigation include: Sorafenib (DRUG), MLN0128 (DRUG), MLN0128 (RP2D) (DRUG).
Who is sponsoring clinical trial NCT02575339?
This trial is sponsored by Kathy Miller, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02575339's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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