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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 is a Phase 2 study that has completed, run by Calithera Biosciences. The registered enrollment target is 118 participants.

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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.

Interventions

  • DRUG Exemestane
  • DRUG Fulvestrant
  • DRUG Sapanisertib

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2014-02-13
Est. Completion 2018-06-29
Phase Phase 2

Sponsor

Calithera Biosciences

22 total trials

What the Registry Record Tells You About NCT02049957

The ClinicalTrials.gov registry entry for NCT02049957 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.

NCT02049957 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.