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NCT02756364 · ClinicalTrials.gov registry record · Phase 2
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
A Phase 2 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
NCT02756364: Completed Phase 2 study, sponsored by Calithera Biosciences.
NCT02756364 is a Phase 2 study that has completed, run by Calithera Biosciences. The registered enrollment target is 141 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02756364, a Phase 2 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Interventions
- DRUG Fulvestrant
- DRUG Sapanisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2016-07-28 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
What the finished NCT02756364 record still lists
NCT02756364 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT02756364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02756364 about?
NCT02756364 is a clinical study titled "Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy". The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.
What is the current status of trial NCT02756364?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2016-07-28. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT02756364?
The interventions under investigation include: Fulvestrant (DRUG), Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT02756364?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02756364's enrollment target sits among peer trials
141 510th of 2000 higher than 1,489 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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