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NCT02049957 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
A Phase 2 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT02049957: Completed Phase 2 study, sponsored by Calithera Biosciences.
NCT02049957 is a Phase 2 study that has completed, run by Calithera Biosciences. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02049957, a Phase 2 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.
Primary Outcome
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, re
Interventions
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Sapanisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2014-02-13 |
| Est. Completion | 2018-06-29 |
| Phase | Phase 2 |
What the finished NCT02049957 record still lists
NCT02049957 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT02049957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02049957 about?
NCT02049957 is a clinical study titled "Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer". This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatmen...
What is the current status of trial NCT02049957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2014-02-13. Estimated completion is 2018-06-29.
What interventions are being tested in trial NCT02049957?
The interventions under investigation include: Exemestane (DRUG), Fulvestrant (DRUG), Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT02049957?
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 NCT02049957's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 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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