A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01981850 |
Recruitment Status :
Completed
First Posted : November 13, 2013
Results First Posted : January 5, 2022
Last Update Posted : January 5, 2022
|
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Primary Myelofibrosis Polycythemia Vera Post-Essential Thrombocythemia Myelofibrosis |
Interventions |
Biological: RO7490677 Drug: Ruxolitinib |
Enrollment | 125 |
Participant Flow
Recruitment Details | A total of 125 participants were enrolled at sites in 8 different countries. |
Pre-assignment Details | One randomized participant in Stage 2 did not receive the study treatment, bringing the total number of treated participants to 124. |
Arm/Group Title | Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) | Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) | Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib | Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib | Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W | Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W | Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W | OLE Stage 1: RO7490677 10 mg/kg IV Q4W | OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib | OLE Stage 2: RO7490677 10 mg/kg IV Q4W |
---|---|---|---|---|---|---|---|---|---|---|
![]() |
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. | Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. | Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle. | Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle. | Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle. |
Period Title: Main Phase Stage 1 | ||||||||||
Started | 8 | 7 | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
Completed [1] | 5 | 5 | 4 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
Not Completed | 3 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Reason Not Completed | ||||||||||
Death | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Informed Consent Withdrawn | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Lack of Efficacy | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Various reasons | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[1]
Main Study
|
||||||||||
Period Title: Main Phase Stage 2 | ||||||||||
Started | 0 | 0 | 0 | 0 | 33 | 32 | 32 | 0 | 0 | 0 |
Completed [1] | 0 | 0 | 0 | 0 | 20 | 16 | 15 | 0 | 0 | 0 |
Not Completed | 0 | 0 | 0 | 0 | 13 | 16 | 17 | 0 | 0 | 0 |
Reason Not Completed | ||||||||||
Adverse Event | 0 | 0 | 0 | 0 | 6 | 5 | 7 | 0 | 0 | 0 |
Informed Consent Withdrawn | 0 | 0 | 0 | 0 | 4 | 3 | 3 | 0 | 0 | 0 |
Lack of Efficacy | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
Various reasons | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
Progressive Disease | 0 | 0 | 0 | 0 | 0 | 6 | 6 | 0 | 0 | 0 |
[1]
Main Study
|
||||||||||
Period Title: Open Label Extension (OLE) | ||||||||||
Started [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 5 | 48 |
Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 5 | 48 |
Reason Not Completed | ||||||||||
Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 8 |
Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 19 |
Various reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 3 |
Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 9 |
Informed Consent Withdrawn | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
[1]
Continued in OLE
|
Baseline Characteristics
Arm/Group Title | Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW) | Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W) | Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib | Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib | Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W | Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W | Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W | Total | |
---|---|---|---|---|---|---|---|---|---|
![]() |
Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. | Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. | Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. | Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 7 | 6 | 6 | 33 | 32 | 32 | 124 | |
![]() |
Stage 1 & Stage 2 reported separately.
|
||||||||
Age, Continuous
[1] [2] Mean (Standard Deviation) Unit of measure: Years |
|||||||||
Number Analyzed | 8 participants | 7 participants | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants | 27 participants | |
64.3 (11.4) | 70.7 (6.3) | 66.0 (7.3) | 66.2 (8.6) | 66.7 (8.7) | |||||
[1]
Measure Description: Participants in the Main Phase Stage 1 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 1 reported separately from Main Phase Stage 2.
|
|||||||||
Age, Continuous
[1] [2] Mean (Standard Deviation) Unit of measure: Years |
|||||||||
Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 33 participants | 32 participants | 32 participants | 97 participants | |
70.6 (7.1) | 70.2 (6.5) | 69.4 (8.9) | 70.1 (7.5) | ||||||
[1]
Measure Description: Participants in the Main Phase Stage 2 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 2 reported separately from Main Phase Stage 1.
|
|||||||||
Sex: Female, Male
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 8 participants | 7 participants | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants | 27 participants | |
Female |
5 62.5%
|
2 28.6%
|
3 50.0%
|
5 83.3%
|
15 55.6%
|
||||
Male |
3 37.5%
|
5 71.4%
|
3 50.0%
|
1 16.7%
|
12 44.4%
|
||||
[1]
Measure Description: Participants in the Main Phase Stage 1 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 1 reported separately from Main Phase Stage 2.
|
|||||||||
Sex: Female, Male
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 33 participants | 32 participants | 32 participants | 97 participants | |
Female |
16 48.5%
|
8 25.0%
|
11 34.4%
|
35 36.1%
|
|||||
Male |
17 51.5%
|
24 75.0%
|
21 65.6%
|
62 63.9%
|
|||||
[1]
Measure Description: Participants in the Main Phase Stage 2 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 2 reported separately from Main Phase Stage 1.
|
|||||||||
Ethnicity (NIH/OMB)
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 8 participants | 7 participants | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants | 27 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
1 3.7%
|
||||
Not Hispanic or Latino |
8 100.0%
|
7 100.0%
|
4 66.7%
|
6 100.0%
|
25 92.6%
|
||||
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
1 3.7%
|
||||
[1]
Measure Description: Participants in the Main Phase Stage 1 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 1 reported separately from Main Phase Stage 2.
|
|||||||||
Race (NIH/OMB)
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 8 participants | 7 participants | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants | 27 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
1 3.7%
|
||||
Asian |
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
1 3.7%
|
||||
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
||||
Black or African American |
1 12.5%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
2 7.4%
|
||||
White |
7 87.5%
|
7 100.0%
|
3 50.0%
|
6 100.0%
|
23 85.2%
|
||||
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
||||
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
||||
[1]
Measure Description: Participants in the Main Phase Stage 1 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 1 reported separately from Main Phase Stage 2.
|
|||||||||
Race (NIH/OMB)
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 33 participants | 32 participants | 32 participants | 97 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|||||
Asian |
0 0.0%
|
1 3.1%
|
2 6.3%
|
3 3.1%
|
|||||
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|||||
Black or African American |
0 0.0%
|
1 3.1%
|
0 0.0%
|
1 1.0%
|
|||||
White |
33 100.0%
|
29 90.6%
|
29 90.6%
|
91 93.8%
|
|||||
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|||||
Unknown or Not Reported |
0 0.0%
|
1 3.1%
|
1 3.1%
|
2 2.1%
|
|||||
[1]
Measure Description: Participants in the Main Phase Stage 2 part of the study
[2]
Measure Analysis Population Description: Main Phase Stage 2 reported separately from Main Phase Stage 1.
|
Outcome Measures
Adverse Events