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NCT04729387 · ClinicalTrials.gov registry record · Phase 3
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
NCT04729387: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04729387 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 358 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04729387, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
Study Summary
The objective of this study was to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.
Primary Outcome
Progression-free survival (PFS) was defined as the time from randomization to the first documented disease progression or death from any cause, as determined by blinded independent review committee (BIRC) assessment. Participants without an event were censored at the date of their last adequate tumor assessment. Clinical deterioration without objective radiologic evidence was not considered disease progression in the primary efficacy analysis. Disease progression was defined according to Respon
Interventions
- DRUG Olaparib
- DRUG Paclitaxel
- DRUG Alpelisib
- DRUG Pegylated liposomal doxorubicin (PLD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2021-07-22 |
| Est. Completion | 2026-01-19 |
| Phase | Phase 3 |
Why NCT04729387 stopped before completion
NCT04729387 is an interventional study that assigns participants to a tested intervention. The registered 358 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 (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Olaparib is the first listed.
NCT04729387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04729387 about?
NCT04729387 is a clinical study titled "Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected". The objective of this study was to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.
What is the current status of trial NCT04729387?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2021-07-22. Estimated completion is 2026-01-19.
What interventions are being tested in trial NCT04729387?
The interventions under investigation include: Olaparib (DRUG), Paclitaxel (DRUG), Alpelisib (DRUG), Pegylated liposomal doxorubicin (PLD) (DRUG).
Who is sponsoring clinical trial NCT04729387?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04729387's enrollment target sits among peer trials
358 1022nd of 2000 higher than 978 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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