89. Lymphangioleiomyomatosis Clinical trials / Disease details


Clinical trials : 38 Drugs : 38 - (DrugBank : 15) / Drug target genes : 18 - Drug target pathways : 118

  
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PhaseCountries
1EUCTR2020-000702-29-ES
(EUCTR)
07/06/202109/02/2021Evaluating the effect of Loratadine associated with Rapamune in Lymphagioleiomyomatosis (LAM).Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM). EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSIS
MedDRA version: 21.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Loratadina STADA 10 mg
Product Name: Loratadina Stada
INN or Proposed INN: LORATADINE
Other descriptive name: LORATADINE
IDIBELL (Institut d’Investigació Biomédica de Bellvitge)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
62Phase 2Spain
2NCT04388371
(ClinicalTrials.gov)
October 18, 201911/5/2020Glutamine PET Imaging in LAMGlutamine PET Imaging in LAMLymphangioleiomyomatosis (LAM)Drug: GlutamineVanderbilt University Medical CenterThe LAM FoundationCompleted18 YearsN/AFemale5Phase 1United States
3NCT04273334
(ClinicalTrials.gov)
October 1, 201915/2/2020Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic DisordersApplication of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.Lymphatic DisordersDrug: 68Ga-NEBPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll90Phase 1China
4NCT03253913
(ClinicalTrials.gov)
March 31, 201810/8/2017Resveratrol and Sirolimus in Lymphangioleiomyomatosis TrialResveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (RESULT)LymphangioleiomyomatosisDrug: Sirolimus;Drug: ResveratrolUniversity of CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting18 YearsN/AFemale25Phase 2United States
5NCT03131999
(ClinicalTrials.gov)
January 23, 201824/4/2017LAM Pilot Study With Imatinib MesylateLAM Pilot Study With Imatinib MesylateLymphangioleiomyomatosisDrug: Imatinib Mesylate 400Mg Capsule;Drug: Placebo - CapsuleMedical University of South CarolinaColumbia UniversityCompleted18 YearsN/AAll18Phase 1/Phase 2United States
6NCT03150914
(ClinicalTrials.gov)
January 1, 201810/5/2017Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease TrialMulticenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease TrialLAM;LymphangioleiomyomatosisDrug: SirolimusUniversity of CincinnatiNational Heart, Lung, and Blood Institute (NHLBI);National Center for Advancing Translational Science (NCATS);The LAM FoundationRecruiting18 YearsN/AFemale60Phase 3United States
7NCT03062943
(ClinicalTrials.gov)
December 6, 20167/10/2016A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)A Pilot Study of Nintedanib for LymphAngioleioMyomatosis (LAM)LymphangioleiomyomatosisDrug: NintedanibIRCCS MultimedicaNULLCompleted18 YearsN/AFemale30Phase 2Italy
8NCT02484664
(ClinicalTrials.gov)
June 15, 201625/6/2015COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSCCOLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSCLymphangioleiomyomatosis (LAM)Drug: CelecoxibBrigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Completed18 Years70 YearsFemale12Phase 2United States
9NCT02737202
(ClinicalTrials.gov)
April 201631/3/2016Safety and Efficacy of Saracatinib In Subjects With LymphangioleiomyomatosisSafety and Efficacy of Saracatinib In Subjects With LymphangioleiomyomatosisPulmonary LymphangioleiomyomatosisDrug: saracatinibBaylor College of MedicineUniversity of Cincinnati;Brigham and Women's Hospital;Stanford University;Loyola University;University of South Florida;National Institutes of Health (NIH)Terminated18 Years65 YearsFemale28Phase 2United States
10EUCTR2015-004919-20-IT
(EUCTR)
09/03/201611/08/2016A pilot study of nintedanib for lymphangioleiomyomatosis (LAM)A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) - A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) Female subjects affected by Llymphangioleiomyomatosis (LAM)
MedDRA version: 19.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: OfevMULTIMEDICA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
30Phase 3Italy
11NCT02432560
(ClinicalTrials.gov)
March 20154/3/2015Safety and Durability of Sirolimus for Treatment of LAMMulticenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)LymphangioleiomyomatosisDrug: Sirolimus;Drug: EverolimusUniversity of CincinnatiRare Diseases Clinical Research Network;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);The LAM FoundationRecruiting18 YearsN/AFemale600United States
12JPRN-UMIN000016677
2015/01/0102/03/2015Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosisEfficacy and safety of low dose sirolimus in lymphangioleiomyomatosis - Low dose sirolimus study lymphangioleiomyomatosissirolimus 1mg/day / sirolimus 2mg/dayNational Hospital Organization Kinki-chuo Chest Medical CenterNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
13NCT02116712
(ClinicalTrials.gov)
August 201415/4/2014The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1)The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1)Pulmonary LymphangioleiomyomatosisDrug: SaracatinibTony EissaUniversity of Texas;University of CincinnatiCompleted18 Years65 YearsBoth9Phase 1United States
14NCT02061397
(ClinicalTrials.gov)
March 201423/1/2014Safety of Simvastatin in LAM and TSCThe Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC)Lymphangioleiomyomatosis;Tuberous Sclerosis ComplexDrug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral ProductUniversity of PennsylvaniaThe LAM FoundationCompleted18 YearsN/AFemale10Phase 1/Phase 2United States
15NCT01799538
(ClinicalTrials.gov)
June 10, 201323/2/2013Nebulized or Inhaled Albuterol for LymphangioleiomyomatosisBronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With LymphangioleiomyomatosisLymphangioleiomyomatosisDrug: albuterol inhaler;Drug: albuterol nebulizer;Procedure: PFTNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting18 YearsN/AFemale100Phase 1/Phase 2United States
16JPRN-JMA-IIA00096
05/09/201217/08/2012multicenter lymphangioleiomyomatosis sirolimus trial for safetymulticenter lymphangioleiomyomatosis sirolimus trial for safety lymphangioleiomyomatosisIntervention type:DRUG. Intervention1:Srolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years and modified dosage between 1mg and 3mg QD depend on the plasma concentration monitoring..Koh Nakata, MD, PhDYoshikazu InoueKuniaki SeyamaRyushi TazawaToshinori TakadaCompleted>=18 YEARSNo LimitFemale65Phase 2Japan
17NCT01687179
(ClinicalTrials.gov)
September 20122/8/2012Safety Study of Sirolimus and Hydroxychloroquine in Women With LymphangioleiomyomatosisTargeting Autophagy for the Treatment of TSC and LAM: a Phase I Trial of Hydroxychloroquine and SirolimusLymphangioleiomyomatosisDrug: Sirolimus and Hydroxychloroquine 200 mg;Drug: Sirolimus and Hydroxychloroquine 400 mgBrigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Completed18 Years85 YearsFemale14Phase 1United States
18JPRN-UMIN000007387
2012/03/3101/04/2012Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosisClinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis - Long-term administration of sirolimus for lymphangioleiomyomatosis lymphangioleiomyomatosissirolimusKobe University Graduate School of MedicineNULLComplete: follow-up completeNot applicableNot applicableFemale1Not applicableJapan
19JPRN-JMA-IIA00037
01/10/201115/03/2010MLLTS trialMulticenter Lymphangioleiomyomatosis Long Term Sirolimus Trial lymphangioleiomyomatosisIntervention type:DRUG. Intervention1:sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years..Koh Nakata, MD, Ph.DRyushi TazawaOther>=18 YEARSNo LimitFemale50Phase 2Japan
20NCT01353209
(ClinicalTrials.gov)
May 201111/5/2011Trial of Aromatase Inhibition in LymphangioleiomyomatosisA TRIAL OF LETROZOLE IN PULMONARY LYMPHANGIOLEIOMYOMATOSISLymphangioleiomyomatosisDrug: Letrozole;Drug: PlaceboUniversity of CincinnatiDepartment of DefenseCompleted18 YearsN/AFemale17Phase 2United States
21EUCTR2010-019825-32-IT
(EUCTR)
28/07/201018/05/2010An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - NDAn exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - ND Lymphangioleiomyomatosis
MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis
INN or Proposed INN: Everolimus
INN or Proposed INN: Everolimus
INN or Proposed INN: Everolimus
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: no
24France;Italy
22EUCTR2010-019825-32-FR
(EUCTR)
29/06/201028/05/2010An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosisAn exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosis Lymphangioleiomyomatosis
MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis
Product Code: RAD001
INN or Proposed INN: everolimus
Trade Name: Afinitor
Product Code: RAD001
INN or Proposed INN: everolimus
Trade Name: Afinitor
Product Code: RAD001
INN or Proposed INN: everolimus
Novartis Pharma Service AGNULLNot RecruitingFemale: yes
Male: no
24France;Italy
23EUCTR2008-002113-48-NL
(EUCTR)
16/03/201002/04/2009A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99France;Spain;Germany;Netherlands;Italy;United Kingdom
24NCT01059318
(ClinicalTrials.gov)
January 201028/1/2010A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With LymphangioleiomyomatosisAn Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With LymphangioleiomyomatosisLymphangioleiomyomatosisDrug: EverolimusNovartis PharmaceuticalsNULLCompleted18 YearsN/AFemale24Phase 2United States;France;Italy;Germany
25EUCTR2008-002113-48-IT
(EUCTR)
03/09/200907/09/2009A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - NDA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - ND Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 12.0;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: Everolimus
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
99France;Spain;Netherlands;Germany;United Kingdom;Italy
26EUCTR2008-002113-48-GB
(EUCTR)
06/08/200922/05/2009Efficacy and Safety of RAD001 in patients aged 18 and over with Angiomyolipoma associated with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 17.0;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Trade Name: Afinitor 5mg Tablets
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
118 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;Japan;United Kingdom
27NCT00989742
(ClinicalTrials.gov)
July 20092/10/2009Doxycycline In Lymphangioleiomyomatosis (LAM)A Randomised, Double Blind, Placebo Controlled Trial of Doxycycline in Lymphangioleiomyomatosis.Lymphangioleiomyomatosis;Tuberous SclerosisDrug: Doxycycline;Drug: PlaceboUniversity of NottinghamNULLCompleted18 YearsN/AFemale24Phase 4United Kingdom
28NCT00790400
(ClinicalTrials.gov)
April 200910/11/2008Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)Tuberous Sclerosis Complex (TSC);Lymphangioleiomyomatosis (LAM)Drug: Everolimus (RAD001);Drug: Everolimus PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll118Phase 3United States;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom
29EUCTR2008-002113-48-FR
(EUCTR)
18/03/200919/03/2009A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99Phase 3France;Spain;Netherlands;Germany;Italy;United Kingdom
30EUCTR2007-003745-32-GB
(EUCTR)
12/12/200826/11/2010A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAMA randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM Lymphangioleiomyomatosis
MedDRA version: 9.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis
MedDRA version: 9.1;Level: PT;Term: Lymphangioleiomyomatosis
Trade Name: Doxycycline 100 mg Capsules
INN or Proposed INN: doxycycline
University of NottinghamNULLNot RecruitingFemale: yes
Male: no
United Kingdom
31NCT00792766
(ClinicalTrials.gov)
December 200817/11/2008Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM)Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;AngiolipomaDrug: everolimus (RAD001)Children's Hospital Medical Center, CincinnatiNovartisCompleted18 Years65 YearsBoth20Phase 1/Phase 2United States
32JPRN-JMA-IIA00011
08/05/200829/06/2007Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial)Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) Lymphangioleiomyomatosis (LAM)Intervention type:DRUG. Intervention1:Sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:12 months on, 12 months off. Control intervention1:Placebo, Dose form:TABLET, Route of administration:ORAL, Intended dose regimen:12 months on, 12 months off.Frank McCormack, M.D., University of Cincinnati Medical Center Director, Division of Pulmonary and Critical Care Medicinea.Alan F. Barker, M.D. - Oregon Health & Sciences University b.Kevin Brown, M.D., - National Jewish Medical & Research Center c.Edwin K. Silverman, M.D., Ph.D. - Harvard/Brigham & Women's Hospital d.James M. Stocks, M.D. - University of Texas Health Centere.James K. Stoller, M.D. - Cleveland Clinic Foundation f.Charlie Strange, M.D. - Medical University of South Carolina g.Bruce Trapnell, M.D.-Cincinnati Children's Medical Centerh.Mark Brantly, M.D.-University of Florida, Gainesvillei.Yosdhikazu Inoue, M.D., National Hospital Organization (NHO) Kinki-Chuo Chest Medical Centerj.Koh Nakata, M.D., Ph.D., Bioscience Medical Research Center, Niigata University Medical and Dental Hospitalk.Joel Moss, M.D., Ph.D-National Institutes of HealthCompleted>=18 YEARSFemale120Phase 3Japan, United States, Canada
33NCT00414648
(ClinicalTrials.gov)
December 200620/12/2006Efficacy and Safety of Sirolimus for Treating Lymphangioleiomyomatosis (LAM)Lymphangioleiomyomatosis Efficacy and Safety TrialLymphangioleiomyomatosisDrug: Sirolimus;Drug: Placebo sirolimusOffice of Rare Diseases (ORD)FDA Office of Orphan Products DevelopmentActive, not recruiting18 YearsN/AFemale120Phase 3United States;Canada;Japan
34NCT00490789
(ClinicalTrials.gov)
October 200521/6/2007Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAMA Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: sirolimusCardiff UniversityUniversity of Nottingham;St Georges Hospital Medical School;Royal Sussex County Hospital;The Tuberous Sclerosis Association;Wyeth is now a wholly owned subsidiary of PfizerActive, not recruiting18 Years65 YearsBoth14Phase 2United Kingdom
35NCT00457964
(ClinicalTrials.gov)
August 20056/4/2007RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAMRAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: RAD001Children's Hospital Medical Center, CincinnatiNovartis PharmaceuticalsCompleted18 Years65 YearsBoth36Phase 1/Phase 2United States
36NCT00457808
(ClinicalTrials.gov)
December 20026/4/2007Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAMRapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: Rapamycin, sirolimusChildren's Hospital Medical Center, CincinnatiThe LAM Foundation;Tuberous Sclerosis AllianceCompleted18 Years65 YearsBoth25Phase 2United States
37NCT00005906
(ClinicalTrials.gov)
June 20009/6/2000Treatment With Octreotide in Patients With LymphangioleiomyomatosisTreatment With Octreotide in Patients With LymphangioleiomyomatosisLymphangioleiomyomatosis;Lymphangiomyomas;Pleural Effusions;AscitesDrug: OctreotideNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted18 Years65 YearsFemale4Phase 2United States
38EUCTR2008-002113-48-DE
(EUCTR)
12/02/2009Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 16.1;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Afinitor
Product Name: RAD001 5mg
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
118Phase 3France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan