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

NCT ID: NCT02292446

Last Updated: 2019-07-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-21

Study Completion Date

2017-12-29

Brief Summary

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

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Detailed Description

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Conditions

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Polycythemia Vera

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally

Interventions

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Ruxolitinib

supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally

Intervention Type DRUG

Eligibility Criteria

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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; did 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 were pregnant or nursing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Linz, , Austria

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Novartis Investigative Site

Salzburg, , Austria

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Wels, , Austria

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Antwerp, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Yvoir, , Belgium

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, , Chile

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Santiago, , Chile

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Bayonne, Bayonne Cedex, France

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Le Mans, Cedex 09, France

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Angers, , France

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Avignon, , France

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Bordeaux, , France

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Chambéry, , France

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Marseille, , France

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Meaux, , France

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Metz, , France

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Mulhouse, , France

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Nice, , France

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Paris, , France

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Perpignan, , France

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Pringy, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Mannheim, Baden-Wurttemberg, Germany

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Soden, , Germany

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Berlin, , Germany

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Bottrop, , Germany

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Eisenach, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Frankfurt, , Germany

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Friedrichshafen, , Germany

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Hamburg, , Germany

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Hamm, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Koblenz, , Germany

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Mutlangen, , Germany

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Stuttgart, , Germany

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Würzburg, , Germany

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Monterrey, Nuevo León, Mexico

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Novartis Investigative Site

Fredrikstad, , Norway

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Novartis Investigative Site

Tromsø, , Norway

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Novartis Investigative Site

Lisbon, , Portugal

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Novartis Investigative Site

Lisbon, , Portugal

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Novartis Investigative Site

Luleå, , Sweden

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Novartis Investigative Site

Uddevalla, , Sweden

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Novartis Investigative Site

Khon Kaen, THA, Thailand

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Novartis Investigative Site

Bangkok, , Thailand

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Novartis Investigative Site

Bangkok, , Thailand

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Novartis Investigative Site

Chiang Mai, , Thailand

Site Status

Countries

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Austria Belgium Bulgaria Canada Chile France Germany Mexico Norway Portugal Sweden Thailand

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CINC424B2001X

Identifier Type: -

Identifier Source: org_study_id

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