Clinical Trials Logo
  1. Home
  2. Hematopoietic Neoplasm
  3. NCT01523171
  4. Details
NCT01523171 Clinical Trial

Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib

Hematopoietic Neoplasm Clinical Trial

— JAKARTA2  

Official title:
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01523171
Other study ID # ARD12181
Secondary ID 2011-005226-21U1
Status Completed
Phase Phase 2
First received January 27, 2012
Last updated February 17, 2016
Start date April 2012
Est. completion date April 2014

Study information
Verified date February 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;

Secondary Objectives:

- To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary

- To evaluate the durability of splenic response

- To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6

- To evaluate the splenic response to SAR302503 at the end of Cycle 3

- To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden

- To evaluate the safety and tolerability of SAR302503 in this population

- To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

Description:

The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subjects who will not continue the treatment after completing the 6 cycles of SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit which should occur 30 days after the last administration of SAR302503. Patients who continue to benefit clinically will be allowed to remain on study medication beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.

Read more »

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SAR302503
Pharmaceutical form:capsule Route of administration: oral
See more »

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response Rate (RR), defined as the proportion of subjects who have a =35% reduction from baseline in volume of spleen at the end of Cycle 6 as measured by Magnetic Resonance Imaging (MRI) (or CT scan in subjects with contraindications for MRI) 6 months Yes
Secondary Symptom Response Rate (SRR): Proportion of subjects with a =50% reduction from baseline to the end of Cycle 6 in the total symptom score using the modified MFSAF 6 months No
Secondary Duration of spleen response, measured by MRI (or CT scan in subjects with contraindications for MRI) 6 months No
Secondary Proportion of subjects with a =50% reduction in length of spleen by palpation from baseline at the end of Cycle 6 6 months No
Secondary Response Rate at the end of Cycle 3, defined as the proportion of subjects who have a =35% reduction from baseline in volume of spleen at the end of Cycle 3 as measured by MRI (or CT scan in subjects with contraindications for MRI) 6 months No
Secondary Percent change of spleen volume at the end of Cycles 3 and 6 from baseline as measured by MRI (or CT scan in subjects with contraindications for MRI) 6 months No
Secondary Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03 approximately 5 years Yes
Secondary Plasma concentrations of SAR302503 4 months No
Secondary The effect of SAR302503 on the JAK2V617F allele burden 2 years No
See also
  Status Clinical Trial Phase
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
Completed NCT01420783 - Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia Phase 2
Recruiting NCT05759975 - Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT N/A
Completed NCT01437787 - Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis Phase 3
Completed NCT03377010 - UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors
Completed NCT01420770 - Phase 2 Study of SAR302503 in Patients With Myelofibrosis Phase 2