NCT02077933 is a Phase 1 clinical trial of alpelisib in Neoplasms, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02077933?

NCT02077933 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02077933?

Interventions in NCT02077933: alpelisib, everolimus, exemestane.

What condition does NCT02077933 study?

NCT02077933 studies Neoplasms, Breast Neoplasms, Kidney Neoplasms, Pancreatic Neuroendocine Neoplasms (pNETs).

Is NCT02077933 still recruiting?

NCT02077933 is currently completed. Last updated 8 December 2020.

Last reviewed 2020-12-08 · How we verify

NCT02077933

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 8 December 2020

What this trial tests

Phase 1 trial testing alpelisib in Neoplasms in 79 participants. Completed in 12 April 2019.

Timeline

14 May 2014

Primary endpoint
12 April 2019

12 April 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	79
Start date	14 May 2014
Primary completion	12 April 2019
Estimated completion	12 April 2019
Sites	22 locations across France, Hong Kong, Italy, Netherlands, United Kingdom, Germany, Hungary, United States

Drugs / interventions tested

alpelisib (alpelisib) — full drug profile →
everolimus (everolimus) — full drug profile →
exemestane (exemestane) — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →
Breast Neoplasms — all drugs for Breast Neoplasms →
Kidney Neoplasms — all drugs for Kidney Neoplasms →
Pancreatic Neuroendocine Neoplasms (pNETs) — all drugs for Pancreatic Neuroendocine Neoplasms (pNETs) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Neoplasms or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.
Mishra R, Patel H, Alanazi S, Kilroy MK, et al · · 2021 · cited 207× · PMID 33801659 · DOI 10.3390/ijms22073464
PI3K/Akt/mTOR inhibitors in breast cancer.
Lee JJ, Loh K, Yap YS. · · 2015 · cited 203× · PMID 26779371 · DOI 10.7497/j.issn.2095-3941.2015.0089
PI3K inhibitors as new cancer therapeutics: implications for clinical trial design.
Massacesi C, Di Tomaso E, Urban P, Germa C, et al · · 2016 · cited 171× · PMID 26793003 · DOI 10.2147/ott.s89967
Targeting Cancer Metabolism: Dietary and Pharmacologic Interventions.
Vernieri C, Casola S, Foiani M, Pietrantonio F, et al · · 2016 · cited 155× · PMID 27872127 · DOI 10.1158/2159-8290.cd-16-0615
Hypoxia as a barrier to immunotherapy in pancreatic adenocarcinoma.
Daniel SK, Sullivan KM, Labadie KP, Pillarisetty VG. · · 2019 · cited 148× · PMID 30931508 · DOI 10.1186/s40169-019-0226-9
Receptor tyrosine kinases and downstream pathways as druggable targets for cancer treatment: the current arsenal of inhibitors.
Montor WR, Salas AROSE, Melo FHM. · · 2018 · cited 80× · PMID 29455659 · DOI 10.1186/s12943-018-0792-2

Verify or expand the search:

Other trials of alpelisib

Trials testing the same drug.

NCT04285723 — Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib · completed
NCT04251533 — Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a · Phase 3 · terminated
NCT01923168 — Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women · Phase 2 · completed
NCT04085653 — Managed Access Programs for BYL719, Alpelisib · available
NCT03706573 — Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer · no longer available

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02077933 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 8 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02077933.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing