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Spots Global Cancer Trial Database for Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia

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Trial Identification

Brief Title: Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia

Official Title: A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea

Study ID: NCT01420783

Interventions

SAR302503

Study Description

Brief Summary: Primary Objective: * Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for : * Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and * Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia. * PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for: * Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and * Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET. Secondary Objectives: * To evaluate the safety of SAR302503. * To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility. * To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts. * To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8. * To evaluate splenic response as measured by spleen volume using MRI or CT. * To evaluate the pharmacokinetics of SAR302503 after single and repeat doses. * To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition. * To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life. * To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.

Detailed Description: The duration of the study for an individual patient is at least 40 weeks and will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of up to 8, 28-day cycles (32 weeks), and a follow-up visit 30 days following the last administration of study drug. Treatment may continue if the patient is deriving benefit and does not experience disease progression, unacceptable toxicity, or meet other study withdrawal criteria. Per Protocol Amendment No. 5, accrual of patients with essential thrombocythemia is closed.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Investigational Site Number 840008, Scottsdale, Arizona, United States

Investigational Site Number 840004, La Jolla, California, United States

Investigational Site Number 840005, Los Angeles, California, United States

Investigational Site Number 840011, Palo Alto, California, United States

Investigational Site Number 840010, Ann Arbor, Michigan, United States

Investigational Site Number 840007, Rochester, Minnesota, United States

Investigational Site Number 840003, St Louis, Missouri, United States

Investigational Site Number 840001, Houston, Texas, United States

Investigational Site Number 036001, Clayton, , Australia

Investigational Site Number 036002, Kingswood, , Australia

Investigational Site Number 036004, Kogarah, , Australia

Investigational Site Number 036003, Randwick, , Australia

Investigational Site Number 124002, Montreal, , Canada

Investigational Site Number 124003, Toronto, , Canada

Investigational Site Number 124001, Vancouver, , Canada

Investigational Site Number 250004, Brest, , France

Investigational Site Number 250003, Marseille, , France

Investigational Site Number 250001, Paris Cedex 10, , France

Investigational Site Number 276004, Frankfurt Am Main, , Germany

Investigational Site Number 276003, Mannheim, , Germany

Investigational Site Number 380003, Bologna, , Italy

Investigational Site Number 380001, Firenze, , Italy

Investigational Site Number 380004, Orbassano, , Italy

Investigational Site Number 410001, Seongnam, , Korea, Republic of

Investigational Site Number 410003, Seoul, , Korea, Republic of

Investigational Site Number 410004, Seoul, , Korea, Republic of

Investigational Site Number 410002, Seoul, , Korea, Republic of

Investigational Site Number 724004, Badalona, , Spain

Investigational Site Number 724001, Barcelona, , Spain

Investigational Site Number 724003, Madrid, , Spain

Investigational Site Number 724002, Valencia, , Spain

Investigational Site Number 826001, Belfast, , United Kingdom

Investigational Site Number 826006, Birmingham, , United Kingdom

Investigational Site Number 826003, London, , United Kingdom

Investigational Site Number 826004, London, , United Kingdom

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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