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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 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.

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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.

Conditions Studied

Neoplasms Breast Neoplasms Kidney Neoplasms Pancreatic Neuroendocine Neoplasms (pNETs)

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

FieldValue
Enrollment Target 79 participants
Start Date 2014-05-14
Est. Completion 2019-04-12
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT02077933

The ClinicalTrials.gov registry entry for NCT02077933 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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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.