NCT01769768 is a Phase 1 clinical trial of LDE225 in Advanced Solid Tumor, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01769768?

NCT01769768 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01769768?

Interventions in NCT01769768: LDE225, Wafarin, Bupropion.

What condition does NCT01769768 study?

NCT01769768 studies Advanced Solid Tumor.

Is NCT01769768 still recruiting?

NCT01769768 is currently completed. Last updated 16 December 2020.

Last reviewed 2020-12-16 · How we verify

NCT01769768

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

A Phase Ib, Multi-center, Two Parallel Group, Open-label, Drug-drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 16 December 2020

What this trial tests

Phase 1 trial testing LDE225 in Advanced Solid Tumor in 114 participants. Completed in 1 August 2016.

Timeline

1 April 2013

Primary endpoint
1 August 2016

1 August 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	1 April 2013
Primary completion	1 August 2016
Estimated completion	1 August 2016
Sites	13 locations across United States

Drugs / interventions tested

LDE225 — full drug profile →
Wafarin — full drug profile →
Bupropion (bupropion) — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pharmacokinetics (PK) parameter AUClast for S- and R-warfarin
Time frame: 7 days
Pharmacokinetics of warfarin : Maximum observed plasma concentration after drug administration
PK parameter AUClast for bupropion
Time frame: 7 days
Pharmacokinetics bupropion : Maximum observed plasma concentration after drug administration
PK parameter AUCinf for bupropion
Time frame: 7 days
Pharmacokinetics of bupropion : Maximum observed plasma concentration after drug administration
PK parameter AUCinf for S- and R-warfarin
Time frame: 7 days
Pharmacokinetics of warfarin and bupropion : Maximum observed plasma concentration after drug administration
PK parameter Cmax for S- and R-warfarin
Time frame: 7 days
Pharmacokinetics of warfarin : Maximum observed plasma concentration after drug administration
PK parameters Cmax for bupropion
Time frame: 7 days
Pharmacokinetics of Bupropion : Maximum observed plasma concentration after drug administration

Sponsor's own description

This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.

Publications & conference data

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

Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022
Wound healing and cancer stem cells: inflammation as a driver of treatment resistance in breast cancer.
Arnold KM, Opdenaker LM, Flynn D, Sims-Mourtada J. · · 2015 · cited 84× · PMID 25674014 · DOI 10.4137/cgm.s11286
Cooperative integration between HEDGEHOG-GLI signalling and other oncogenic pathways: implications for cancer therapy.
Pandolfi S, Stecca B. · · 2015 · cited 66× · PMID 25660620 · DOI 10.1017/erm.2015.3
Molecular Mechanisms Involving the Sonic Hedgehog Pathway in Lung Cancer Therapy: Recent Advances.
Ma C, Hu K, Ullah I, Zheng QK, et al · · 2022 · cited 18× · PMID 35433472 · DOI 10.3389/fonc.2022.729088

Verify or expand the search:

Other trials of LDE225

Trials testing the same drug.

NCT01787552 — A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF · Phase 1, PHASE2 · completed
NCT01708174 — A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB) · Phase 2 · completed
NCT01327053 — A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Phase 2 · completed

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · 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 NCT01769768 (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: 16 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/NCT01769768.

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