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Trial record 5 of 234 for:    "Polycythemia vera"

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.

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ClinicalTrials.gov Identifier: NCT02292446
Recruitment Status : Recruiting
First Posted : November 17, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Drug: Ruxolitinib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 23, 2014
Estimated Primary Completion Date : January 2, 2018
Estimated Study Completion Date : January 2, 2018


Arm Intervention/treatment
Experimental: Ruxolitinib
All patients will receive ruxolitinib
Drug: Ruxolitinib



Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 0 to 39 months ]

Secondary Outcome Measures :
  1. Change in hematocrit [ Time Frame: Up to 39 months ]
    Change in Hct levels from Baseline to each visit where measured

  2. Change in spleen [ Time Frame: Up to 39 months ]
    Change in spleen length from Baseline to each visit where measured.

  3. Change in MPN-SAF [ Time Frame: Up to 39 months ]
    Change in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF) from baseline to each visit where measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292446


Contacts
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

  Show 77 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02292446     History of Changes
Other Study ID Numbers: CINC424B2001X
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
INC424
Ruxolitinib

Additional relevant MeSH terms:
Polycythemia Vera
Polycythemia
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors