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NCT01968213 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
A Phase 3 study, sponsored by pharmaand.
- Completed
- Registry status
- Phase 3
- Development phase
- 564
- Enrollment target
NCT01968213: Completed Phase 3 study, sponsored by pharmaand.
NCT01968213 is a Phase 3 study that has completed, run by pharmaand. The registered enrollment target is 564 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968213, a Phase 3 study, has completed, sponsored by pharmaand.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 564 participants
- Enrollment target
Study Summary
Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Primary Outcome
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of
Interventions
- DRUG Placebo
- DRUG Rucaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 564 participants |
| Start Date | 2014-04-07 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 3 |
What the finished NCT01968213 record still lists
NCT01968213 is an interventional study that assigns participants to a tested intervention. The registered 564 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 (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01968213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968213 about?
NCT01968213 is a clinical study titled "Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)". Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous re...
What is the current status of trial NCT01968213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 564 participants. The study started on 2014-04-07. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT01968213?
The interventions under investigation include: Placebo (DRUG), Rucaparib (DRUG).
Who is sponsoring clinical trial NCT01968213?
This trial is sponsored by pharmaand, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01968213's enrollment target sits among peer trials
564 668th of 2000 higher than 1,333 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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