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NCT02077933 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors
A Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT02077933: Completed Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Novartis Pharmaceuticals.
NCT02077933 is a Phase 1 study of Neoplasms and Breast Neoplasms that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 79 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077933, a Phase 1 study of Neoplasms and Breast Neoplasms, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.
Primary Outcome
To determine the MTD and/or RDE of alpelisib in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestane. A dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first 35 days of treatment with alpelisib plus everolimus or alpelisib plus everolimus plus exemestane and meets any of
Conditions Studied
Interventions
- DRUG everolimus
- DRUG exemestane
- DRUG alpelisib
Study Locations (20)
Other
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Hanover
- Novartis Investigative Site - Hong Kong
- Novartis Investigative Site - Budapest
- Novartis Investigative Site - Amsterdam
- Novartis Investigative Site - Utrecht
- Novartis Investigative Site - Madrid
Arkansas
- Highlands Oncology Group - Fayetteville
New York
- Memorial Sloan Kettering Cancer Center SC - BYL719Z2102 - New York
AN
- Novartis Investigative Site - Ancona
MI
- Novartis Investigative Site - Milan
MO
- Novartis Investigative Site - Modena
VR
- Novartis Investigative Site - Verona
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-05-14 |
| Est. Completion | 2019-04-12 |
| Phase | Phase 1 |
What the finished NCT02077933 record still lists
NCT02077933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which everolimus is the first listed.
NCT02077933 names 20 study sites across 8 states, led by Other, Arkansas, New York.
Frequently Asked Questions
What is clinical trial NCT02077933 about?
NCT02077933 is a clinical study titled "Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors". Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisi...
What is the current status of trial NCT02077933?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2014-05-14. Estimated completion is 2019-04-12.
What conditions does trial NCT02077933 study?
This clinical trial studies the following conditions: Neoplasms, Breast Neoplasms, Kidney Neoplasms, Pancreatic Neuroendocine Neoplasms (pNETs).
What interventions are being tested in trial NCT02077933?
The interventions under investigation include: everolimus (DRUG), exemestane (DRUG), alpelisib (DRUG).
Who is sponsoring clinical trial NCT02077933?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02077933 being conducted?
This trial has 20 study locations across Arkansas, New York, AN, MI, MO. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02077933's enrollment target sits among peer trials
79 83rd of 158 higher than 75 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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