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Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycythemia Vera

Intervention: Ruxolitinib (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +41613241111

Summary

The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) is to provide early access to ruxolitinib and evaluate safety information in patients with PV, who are HU resistant or intolerant and who have no other standard treatment option, nor do they qualify for another clinical study for PV.

Clinical Details

Official title: An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary outcome:

Change in hematocrit

Change in spleen

Change in MPN-SAF

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: •Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; does not have access to a comparable or satisfactory alternative treatment Exclusion Criteria: •Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who are pregnant or nursing. Other inclusion/exclusion criteria apply.

Locations and Contacts

Novartis Pharmaceuticals, Phone: +41613241111

Novartis Investigative Site, A-1090 Vienna, Austria; Recruiting

Novartis Investigative Site, Innsbruck 6020, Austria; Withdrawn

Novartis Investigative Site, Linz 4010, Austria; Withdrawn

Novartis Investigative Site, Linz A-4010, Austria; Completed

Novartis Investigative Site, Linz A-4020, Austria; Recruiting

Novartis Investigative Site, Rankweil A-6830, Austria; Completed

Novartis Investigative Site, Salzburg 5020, Austria; Recruiting

Novartis Investigative Site, Wels A-4600, Austria; Recruiting

Novartis Investigative Site, Santiago 8420383, Chile; Not yet recruiting

Novartis Investigative Site, Santiago, Chile; Not yet recruiting

Novartis Investigative Site, Santiago, Chile; Withdrawn

Novartis Investigative Site, Viña del Mar 2540364, Chile; Not yet recruiting

Novartis Investigative Site, Medellín, Colombia; Withdrawn

Novartis Investigative Site, Monteria, Colombia; Withdrawn

Novartis Investigative Site, Angers Cedex 1 49033, France; Recruiting

Novartis Investigative Site, Bayonne 64109, France; Recruiting

Novartis Investigative Site, Bordeaux 33076, France; Not yet recruiting

Novartis Investigative Site, Brest 29200, France; Not yet recruiting

Novartis Investigative Site, Creteil 94010, France; Withdrawn

Novartis Investigative Site, Dunkerque 59240, France; Not yet recruiting

Novartis Investigative Site, Grenoble 38043, France; Withdrawn

Novartis Investigative Site, Marseille 13273, France; Recruiting

Novartis Investigative Site, Meaux cedex 77104, France; Recruiting

Novartis Investigative Site, Metz 57000, France; Recruiting

Novartis Investigative Site, Mulhouse cedex 68070, France; Not yet recruiting

Novartis Investigative Site, Nantes Cedex 1 44093, France; Not yet recruiting

Novartis Investigative Site, Nice Cedex 06202, France; Not yet recruiting

Novartis Investigative Site, Orleans 45100, France; Not yet recruiting

Novartis Investigative Site, Paris 75010, France; Recruiting

Novartis Investigative Site, Perpignan 66046, France; Recruiting

Novartis Investigative Site, Pierre-Benite Cédex F-69495, France; Recruiting

Novartis Investigative Site, Pringy cedex 74374, France; Recruiting

Novartis Investigative Site, Rouen Cedex 1 76038, France; Withdrawn

Novartis Investigative Site, Toulouse Cedex 9 31059, France; Recruiting

Novartis Investigative Site, Vandoeuvre Les Nancy 54511, France; Recruiting

Novartis Investigative Site, Aachen 52074, Germany; Withdrawn

Novartis Investigative Site, Aschaffenburg 63739, Germany; Withdrawn

Novartis Investigative Site, Augsburg 86150, Germany; Withdrawn

Novartis Investigative Site, Augsburg 86156, Germany; Withdrawn

Novartis Investigative Site, Bad Soden 65812, Germany; Recruiting

Novartis Investigative Site, Berlin 10709, Germany; Withdrawn

Novartis Investigative Site, Berlin 13353, Germany; Withdrawn

Novartis Investigative Site, Berlin 13357, Germany; Recruiting

Novartis Investigative Site, Bonn 53119, Germany; Withdrawn

Novartis Investigative Site, Bonn 53113, Germany; Withdrawn

Novartis Investigative Site, Bonn 53105, Germany; Withdrawn

Novartis Investigative Site, Bottrop 46236, Germany; Recruiting

Novartis Investigative Site, Chemnitz 09113, Germany; Withdrawn

Novartis Investigative Site, Dresden 01127, Germany; Withdrawn

Novartis Investigative Site, Dresden 01307, Germany; Withdrawn

Novartis Investigative Site, Duesseldorf 40479, Germany; Withdrawn

Novartis Investigative Site, Eisenach 99817, Germany; Recruiting

Novartis Investigative Site, Erlangen 91054, Germany; Recruiting

Novartis Investigative Site, Frankfurt 60389, Germany; Recruiting

Novartis Investigative Site, Frankfurt 60596, Germany; Withdrawn

Novartis Investigative Site, Friedrichshafen 88045, Germany; Completed

Novartis Investigative Site, Goettingen 37073, Germany; Withdrawn

Novartis Investigative Site, Goslar 38642, Germany; Withdrawn

Novartis Investigative Site, Halle/'Saale 06120, Germany; Withdrawn

Novartis Investigative Site, Hamburg 20099, Germany; Withdrawn

Novartis Investigative Site, Hamburg 20246, Germany; Withdrawn

Novartis Investigative Site, Hamburg 20249, Germany; Withdrawn

Novartis Investigative Site, Hamburg 22081, Germany; Withdrawn

Novartis Investigative Site, Hamm 59063, Germany; Completed

Novartis Investigative Site, Hannover 30170, Germany; Withdrawn

Novartis Investigative Site, Heidelberg 69115, Germany; Withdrawn

Novartis Investigative Site, Heilbronn 74072, Germany; Recruiting

Novartis Investigative Site, Hildesheim 31135, Germany; Withdrawn

Novartis Investigative Site, Kaiserslautern 67655, Germany; Withdrawn

Novartis Investigative Site, Kassel 34119, Germany; Withdrawn

Novartis Investigative Site, Kassel 34125, Germany; Withdrawn

Novartis Investigative Site, Kiel D-24116, Germany; Withdrawn

Novartis Investigative Site, Koblenz 56068, Germany; Recruiting

Novartis Investigative Site, Köln 50937, Germany; Withdrawn

Novartis Investigative Site, Landshut 84028, Germany; Withdrawn

Novartis Investigative Site, Leer 26789, Germany; Withdrawn

Novartis Investigative Site, Lueneburg 21339, Germany; Withdrawn

Novartis Investigative Site, Magdeburg 39120, Germany; Withdrawn

Novartis Investigative Site, Marburg 35037, Germany; Withdrawn

Novartis Investigative Site, Minden 32429, Germany; Withdrawn

Novartis Investigative Site, Muelheim 45468, Germany; Withdrawn

Novartis Investigative Site, Muenster 48149, Germany; Withdrawn

Novartis Investigative Site, Mutlangen 73557, Germany; Completed

Novartis Investigative Site, Northeim 37154, Germany; Withdrawn

Novartis Investigative Site, Nuernberg 90403, Germany; Withdrawn

Novartis Investigative Site, Passau 94036, Germany; Withdrawn

Novartis Investigative Site, Potsdam 14467, Germany; Withdrawn

Novartis Investigative Site, Rehling 86508, Germany; Withdrawn

Novartis Investigative Site, Reutlingen 72764, Germany; Withdrawn

Novartis Investigative Site, Rostock 18057, Germany; Withdrawn

Novartis Investigative Site, Rostock 18107, Germany; Withdrawn

Novartis Investigative Site, Saarbruecken 66113, Germany; Withdrawn

Novartis Investigative Site, Speyer 67346, Germany; Withdrawn

Novartis Investigative Site, Stuttgart 70376, Germany; Withdrawn

Novartis Investigative Site, Ulm 89081, Germany; Withdrawn

Novartis Investigative Site, Wuerzburg 97080, Germany; Recruiting

Novartis Investigative Site, Jakarta 10430, Indonesia; Not yet recruiting

Novartis Investigative Site, Semarang 50244, Indonesia; Not yet recruiting

Novartis Investigative Site, Amman 11191, Jordan; Withdrawn

Novartis Investigative Site, Beirut 1107 2020, Lebanon; Withdrawn

Novartis Investigative Site, Beirut, Lebanon; Withdrawn

Novartis Investigative Site, Fredrikstad NO-1603, Norway; Recruiting

Novartis Investigative Site, Tromso 9038, Norway; Recruiting

Novartis Investigative Site, Trondheim 7006, Norway; Withdrawn

Novartis Investigative Site, Braga 4710-243, Portugal; Not yet recruiting

Novartis Investigative Site, Coimbra 3000-075, Portugal; Not yet recruiting

Novartis Investigative Site, Lisboa 1099 - 023, Portugal; Not yet recruiting

Novartis Investigative Site, Lisboa 1749-035, Portugal; Not yet recruiting

Novartis Investigative Site, Singapore 119228, Singapore; Recruiting

Novartis Investigative Site, Singapore 169608, Singapore; Recruiting

Novartis Investigative Site, Bratislava 85107, Slovakia; Not yet recruiting

Novartis Investigative Site, Kosice 041 90, Slovakia; Not yet recruiting

Novartis Investigative Site, Martin 036 59, Slovakia; Not yet recruiting

Novartis Investigative Site, Bangkok 10400, Thailand; Recruiting

Novartis Investigative Site, Bangkok 10700, Thailand; Recruiting

Novartis Investigative Site, Chiang Mai 50200, Thailand; Recruiting

Novartis Investigative Site, Khon Kaen 40002, Thailand; Recruiting

Novartis Investigative Site, Mannheim, Baden-Württemberg 68305, Germany; Completed

Novartis Investigative Site, Vancouver, British Columbia V5Z 1M9, Canada; Recruiting

Novartis Investigative Site, México, Distrito Federal 14000, Mexico; Not yet recruiting

Novartis Investigative Site, Monterrey, Nuevo León 64020, Mexico; Not yet recruiting

Novartis Investigative Site, Monterrey, Nuevo Léon 64000, Mexico; Not yet recruiting

Novartis Investigative Site, Hamilton, Ontario L8V 5C2, Canada; Not yet recruiting

Additional Information

Starting date: November 2014
Last updated: August 11, 2015

Page last updated: August 23, 2015

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