Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 10:15 PM
Study NCT ID:
NCT01692366
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase 2 Open-Label, Dose-Ranging Study of the Efficacy and Safety of Orally Administered SAR302503 in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
\- To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and combined for the response rate defined with the ≥35% reduction of spleen volume as determined by magnetic resonance imaging (MRI or computed tomography scan \[CT\] in patients with contraindications for MRI).
Secondary Objectives:
* To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual doses population.
* To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose.
* To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF).
* To evaluate the durability of splenic response.
* To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin fibrosis.
\- To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and combined for the response rate defined with the ≥35% reduction of spleen volume as determined by magnetic resonance imaging (MRI or computed tomography scan \[CT\] in patients with contraindications for MRI).
Secondary Objectives:
* To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual doses population.
* To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose.
* To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF).
* To evaluate the durability of splenic response.
* To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin fibrosis.
Detailed Description:
The duration of the study for an individual patient will include a period to assess eligibility (screening period 28 days), followed by a treatment period of at least 1 cycle (28 days) of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are deriving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1130-3710 | OTHER | UTN | View |