Overview

This trial is active, not recruiting.

Condition polycythemia vera
Treatments ruxolitinib tablets, best available therapy (bat)
Phase phase 3
Sponsor Incyte Corporation
Collaborator Novartis Pharmaceuticals
Start date October 2010
End date January 2014
Trial size 222 participants
Trial identifier NCT01243944, CINC424B2301

Summary

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in subjects with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
ruxolitinib tablets
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
(Other)
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
best available therapy (bat) BAT could include:
Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Primary Outcomes

Measure
The Percentage of Subjects Achieving a Primary Response at Week 32
time frame: 32 Weeks

Secondary Outcomes

Measure
The Percentage of Subjects Achieving a Durable Primary Response at Week 48
time frame: 48 Weeks
The Percentage of Subjects Achieving Complete Hematological Remission at Week 32
time frame: 32 Weeks
The Percentage of Subjects Who Achieved a Durable Complete Hematological Remission at Week 48
time frame: 48 Weeks
The Percentage of Subjects Who Achieved a Durable Hematocrit Control at Week 48
time frame: 48 Weeks
The Percentage of Subjects Who Achieved Durable Spleen Volume Reduction at Week 48
time frame: 48 Weeks
Estimated Duration of the Primary Response
time frame: Through study completion
The Percentage of Subjects Who Achieved Overall Clinicohematologic Response at Week 32
time frame: 32 Weeks
The Percentage of Subjects Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48
time frame: 48 Weeks
Estimated Duration of the Overall Clinicohematologic Response
time frame: Through study completion

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria - Subjects resistant to or intolerant of hydroxyurea - Subjects with a phlebotomy requirement - Subjects with a palpable splenomegaly and a spleen volume, as measured by MRI (or CT in applicable subjects), of greater than or equal to 450 cubic centimeters - Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: - Women who are pregnant or nursing - Subjects with inadequate liver or renal function - Subjects with significant bacterial, fungal, parasitic, or viral infection requiring treatment - Subjects with an active malignancy within the past 5 years, excluding specific skin cancers - Subjects with known active hepatitis or HIV positivity - Subjects who have previously received treatment with a JAK inhibitor - Subjects being treated with any investigational agent

Additional Information

Official title Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Incyte Corporation.