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NCT01857193 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT01857193 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 132 participants.
The verdict
NCT01857193, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).
Interventions
- DRUG Exemestane
- DRUG Everolimus (RAD001)
- DRUG ribociclib (LEE011)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2013-09-06 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857193
The ClinicalTrials.gov registry entry for NCT01857193 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT01857193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01857193 about?
NCT01857193 is a clinical study titled "Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer". Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in ...
What is the current status of trial NCT01857193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2013-09-06. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT01857193?
The interventions under investigation include: Exemestane (DRUG), Everolimus (RAD001) (DRUG), ribociclib (LEE011) (DRUG).
Who is sponsoring clinical trial NCT01857193?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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