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NCT01420783 · ClinicalTrials.gov registry record · Phase 2
Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01420783 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 81 participants.
The verdict
NCT01420783, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study 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
Interventions
- DRUG SAR302503
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01420783
The ClinicalTrials.gov registry entry for NCT01420783 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAR302503 is the first listed.
NCT01420783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01420783 about?
NCT01420783 is a clinical study titled "Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia". 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% ...
What is the current status of trial NCT01420783?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2011-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01420783?
The interventions under investigation include: SAR302503 (DRUG).
Who is sponsoring clinical trial NCT01420783?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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