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NCT01849874 · ClinicalTrials.gov registry record · Phase 3
A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 341
- Enrollment target
NCT01849874: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT01849874 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 341 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849874, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 341 participants
- Enrollment target
Study Summary
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.
Primary Outcome
PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a parti
Interventions
- DRUG Physician's choice chemotherapy
- DRUG MEK162, MEK inhibitor; oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2013-06-27 |
| Est. Completion | 2022-08-23 |
| Phase | Phase 3 |
Why NCT01849874 stopped before completion
NCT01849874 is an interventional study that assigns participants to a tested intervention. The registered 341 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Physician's choice chemotherapy is the first listed.
NCT01849874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849874 about?
NCT01849874 is a clinical study titled "A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer". The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen ...
What is the current status of trial NCT01849874?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 341 participants. The study started on 2013-06-27. Estimated completion is 2022-08-23.
What interventions are being tested in trial NCT01849874?
The interventions under investigation include: Physician's choice chemotherapy (DRUG), MEK162, MEK inhibitor; oral (DRUG).
Who is sponsoring clinical trial NCT01849874?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849874's enrollment target sits among peer trials
341 1053rd of 2000 higher than 948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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