Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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

NCT02077933 · View on ClinicalTrials.gov ↗

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.

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

792 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02077933

The ClinicalTrials.gov registry entry for NCT02077933 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02077933 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Arkansas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02077933?

The interventions under investigation include: everolimus (DRUG), exemestane (DRUG), alpelisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02077933?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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