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Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (ADORE)

Primary Purpose

Myelofibrosis

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Ruxolitinib

Siremadlin

Crizanlizumab

Sabatolimab

Rineterkib

NIS793

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring myelofibrosis, ruxolitinib, INC424, siremadlin, HDM201, crizanlizumab, SEG101, sabatolimab, MBG453, rineterkib, LTT462, NIS793, platform study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Core treatment phase Inclusion Criteria:

Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria
Palpable spleen of at least 5 cm from the left costal margin (LCM) to the point of greatest splenic protrusion or enlarged spleen volume of at least 450 cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first dose of study treatment can be accepted).
Have been treated with ruxolitinib for at least 12 weeks prior to first dose of study treatment
Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between 5 and 25 mg twice a day (BID)) for ≥ 4 weeks prior to first dose of study treatment

Extension treatment phase inclusion criteria:

Signed consent for the extension treatment phase
ongoing in the core treatment phase
demonstrates clinical benefit of treatment in core treatment phase per investigator's assessment.

Core treatment phase Exclusion Criteria:

Not able to understand and to comply with study instructions and requirements.
Received any investigational agent for the treatment of MF (except ruxolitinib) within 30 days of first dose of study treatment or within 5 half-lives of the study treatment, whichever is greater
Peripheral blood blasts count of > 10%.
has documented severe hypersensitivity reactions/immunogenicity (IG) to a prior biologic product or Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1 year of screening in NIS793, crizanlizumab or sabatolimab arms, or in rineterkib or siremadlin arms within <=4 weeks of screening or <=5 half-lives whichever is shorter
Splenic irradiation within 6 months prior to the first dose of study drug
Received blood platelet transfusion within 28 days prior to first dose of study treatment.

Extension treatment phase Exclusion Criteria:

meets any of study treatment discontinuation criteria
current evidence of treatment failure per investigator, following treatment in core treatment phase
enrolled in another interventional study
evidence of non-compliance to study procedures or withdrew consent in core treatment phase
currently has unresolved toxicities for which study treatment has been interrupted in the core treatment phase
local access to alternative myelofibrosis treatment including those currently under investigation in clinical trials as assessed suitable in the opinion of the investigator.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Part 1 Arm 1: Ruxolitinib + Siremadlin

Part 1 Arm 2: Ruxolitinib + Crizanlizumab

Part 1 Arm 3: Ruxolitinib + Sabatolimab

Part 2 Arm 1: Ruxolitinib + Siremadlin

Part 2 Arm 2: Ruxolitinib + Crizanlizumab

Part 2 Arm 3: Ruxolitinib + Sabatolimab

Part 2 Arm 6: Ruxolitinib monotherapy

Part 3 Arm 1: Ruxolitinib + Compound X

Part 3 Arm 2: Ruxolitinib cessation

Part 3 Arm 3: Ruxolitinib monotherapy

Part 1 Arm 4: Ruxolitinib + Rineterkib

Part 1 Arm 5: Ruxolitinib + NIS793

Part 2 Arm 4: Ruxolitinib + Rineterkib

Part 2 Arm 5: Ruxolitinib + NIS793

Arm Description

Dose escalation of siremadlin added to existing stable dose of ruxolitinib

Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib

Safety run-in of Sabatolimab added to existing stable dose of ruxolitinib

Siremadlin added to existing stable dose of ruxolitinib

Crizanlizumab added to existing stable dose of ruxolitinib

Sabatolimab added to existing stable dose of ruxolitinib

Existing stable dose of ruxolitinib as control for Part 2

Compound from Part 2 (to be confirmed) added to existing stable dose of ruxolitinib

Compound from Part 2 added to existing stable dose of ruxolitinib for 3 cycles followed by compound monotherapy

Existing stable dose of ruxolitinib as control for Part 3

Dose escalation of Rineterkib added to existing stable dose of ruxolitinib

Safety run-in of NIS793 added to existing stable dose of ruxolitinib

Rineterkib added to existing stable dose of ruxolitinib

NIS793 added to existing stable dose of ruxolitinib

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities within the first 2 cycles

Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study

Response rate at the end of cycle 6 or cycle 8

Composite of anemia improvement (hemoglobin level) and no spleen volume progression and no symptom worsening in Part 2 and Part 3 of the study. For a subject to be considered a responder, all three components of the composite have to be fulfilled

Secondary Outcome Measures

Percentage of subjects achieving an improvement in hemoglobin level of ≥ 1.5 g/dL from baseline

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 1.5 g/dL from baseline at each time point in Part 2 and Part 3 of the study.

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 2.0 g/dL from baseline

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 2.0 g/dL from baseline at each time point in Part 2 and Part 3 of the study.

Change in spleen length from baseline

Change in spleen length measured in centimeters by manual palpation summarized at each time point using descriptive statistics in Part 1 (core and extension), Part 2 and Part 3 of the study

Change in spleen volume from baseline

Change in spleen volume measured by magnetic resonance imaging (MRI) or computed tomography (CT) from baseline summarized at each time point using descriptive statistics, including proportions of subjects who achieved (i) at least 35% spleen volume reduction and (ii) at least 25% spleen volume reduction at the end of Cycle 6 (or 8 for NIS793 arm) (24 weeks) from baseline and, at the end of Cycle 12 (or 16 in NIS793 arm) (48 weeks) from baseline respectively in Part 1 (core and extension) Part 2 and Part 3 of the study

Change in symptoms of MFSAF v4.0 from baseline

Change in total symptom scores (TSS) assessed by the Myelofibrosis (MF Symptom Assessment Form version 4.0 (MFSAF v4.0) at each time point in Part 2 and Part 3 of the study. The MFSAF v4.0 questionnaire focuses on the 7 core symptoms of MF: fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety and bone pain. Subjects record symptom severity at it worst for each of the 7 symptoms on an 11-point numeric rating scale, from 0 (absent) to 10 (worst imaginable). The Total Symptom Score (TSS) is the sum of all the scores for all 7 symptoms.

Change in symptoms of EORTC QLQ-C30 from baseline

Change in symptom scores assessed by European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30) at each time point in Part 2 and Part 3 of the study. The EORTC QLQ-C30 includes 5 functional scales (physical, emotional, social, role, cognitive), eight symptom scales (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond according to the past week recall period, with the exception of the first 5 questions that represent physical functioning and capture the subject's current status. Raw scores are linearly converted to a 0-100 scale. For functional and global health status/QoL higher scores indicate better QoL and level of functioning; for symptom scales, higher scores indicate greater level of symptoms or difficulties.

Changes in symptoms in MFSAF v4.0 (Part 1) from baseline

Change in total symptom scores (TSS) assessed by the Myelofibrosis (MF Symptom Assessment Form version 4.0 (MFSAF v4.0) from baseline including proportion of subjects who achieved at least 50% reduction.

Progression free survival, per progressive splenomegaly, accelerated phase, deteriorating cytopenia, leukemic transformation or death from any cause

Progressive splenomegaly is assessed by increasing spleen volume (by MRI/CT) of ≥ 25% from baseline. Accelerated phase: a circulating peripheral blood blast content of > 10% but < 20% confirmed after 2 weeks. Deteriorating cytopenia (dCP) independent from treatment defined for all patients by platelet count < 35 x10^9/L or neutrophil count < 0.75 x 10^9/L that lasts for at least 4 weeks. Leukemic transformation, a peripheral blood blast content of ≥ 20% associated with an absolute blast count of ≥ 1x10^9/L that lasts for at least 2 weeks or a bone marrow blast count of ≥ 20%.

Percentage of subjects achieving an improvement in bone marrow fibrosis of ≥ 1 grade from baseline

Percentage of subjects achieving an improvement in bone marrow fibrosis of >= 1 grade at each time point will be summarized in Part 2 and Part 3 of the study.

Area under the Plasma Concentration versus Time Curve (AUC)

AUC for each investigational drug in Part 1, Part 2 and Part 3 of the study

Maximum (peak) observed plasma drug concentration (Cmax)

Cmax for each investigational drug in Part 1, Part 2 and Part 3 of the study

Time to reach maximum (peak) plasma, blood, serum or other body fluid drug concentration after single dose administration (Tmax)

Tmax for each investigational drug in Part 1, Part 2 and Part 3 of the study

Concentration versus time profile

Concentration versus time profile for each investigational drug in Part 1, Part 2 and Part 3 of the study

Presence and/or concentration of anti-drug antibody

The presence and titer of anti-drug antibodies for crizanlizumab, sabatolimab and NIS793 in Part 1, Part 2 and Part 3 of the study

Full Information

NCT ID

NCT04097821

First Posted

September 17, 2019

Last Updated

June 7, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04097821

Brief Title

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Acronym

ADORE

Official Title

A Randomized, Open-label, Phase I/II Open Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 26, 2019 (Actual)

Primary Completion Date

June 13, 2022 (Actual)

Study Completion Date

March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the safety, pharmacokinetics and preliminary efficacy of combination treatment of ruxolitinib with 5 novel compounds: siremadlin, crizanlizumab, sabatolimab, rineterkib and NIS793 in myelofibrosis (MF) subjects.

Detailed Description

This open-label, multi-center, phase Ib/II platform study design consists of 3 parts. Part 1 is a phase Ib dose escalation and safety run-in for the 5 novel agents in combination with ruxolitinib to assess safety, tolerability and to confirm recommended Phase II dose. Dose escalation cohorts are treated with ruxoltinib + siremadlin or ruxolitinib + rineterkib. Safety run in cohorts are treated with either ruxolitinb + sabatolimab, ruxolitinb + crizanlizumab or ruxolitinib + NIS793 Parts 2 and 3 are phase II selection and expansion respectively, to assess preliminary efficacy of the combination treatments from Part 1 that are evaluated as safe and tolerable. The number of combination treatment arms opening in part 2 will depend on the results of Part 1. In Part 2, an interim analysis was planned to determine if combination treatment (s) can be expanded in Part 3. In June 2022, Novartis decided to permanently halt the study enrollment in all ongoing parts (part 1 and part 2) and part 3 (expansion) will not be initiated. With protocol amendment 8, an extension treatment phase of 12 cycles is added in Part 1 to allow access to the combination treatment for ongoing subjects deriving clinical benefit. in consideration of the enrollment halt, Parts 2 and 3 objectives will not be pursued and Part 1 objectives are updated accordingly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelofibrosis

Keywords

myelofibrosis, ruxolitinib, INC424, siremadlin, HDM201, crizanlizumab, SEG101, sabatolimab, MBG453, rineterkib, LTT462, NIS793, platform study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Masking

None (Open Label)

Masking Description

Open label

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 Arm 1: Ruxolitinib + Siremadlin

Arm Type

Experimental

Arm Description

Dose escalation of siremadlin added to existing stable dose of ruxolitinib

Arm Title

Part 1 Arm 2: Ruxolitinib + Crizanlizumab

Arm Type

Experimental

Arm Description

Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib

Arm Title

Part 1 Arm 3: Ruxolitinib + Sabatolimab

Arm Type

Experimental

Arm Description

Safety run-in of Sabatolimab added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 1: Ruxolitinib + Siremadlin

Arm Type

Experimental

Arm Description

Siremadlin added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 2: Ruxolitinib + Crizanlizumab

Arm Type

Experimental

Arm Description

Crizanlizumab added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 3: Ruxolitinib + Sabatolimab

Arm Type

Experimental

Arm Description

Sabatolimab added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 6: Ruxolitinib monotherapy

Arm Type

Active Comparator

Arm Description

Existing stable dose of ruxolitinib as control for Part 2

Arm Title

Part 3 Arm 1: Ruxolitinib + Compound X

Arm Type

Experimental

Arm Description

Compound from Part 2 (to be confirmed) added to existing stable dose of ruxolitinib

Arm Title

Part 3 Arm 2: Ruxolitinib cessation

Arm Type

Experimental

Arm Description

Compound from Part 2 added to existing stable dose of ruxolitinib for 3 cycles followed by compound monotherapy

Arm Title

Part 3 Arm 3: Ruxolitinib monotherapy

Arm Type

Active Comparator

Arm Description

Existing stable dose of ruxolitinib as control for Part 3

Arm Title

Part 1 Arm 4: Ruxolitinib + Rineterkib

Arm Type

Experimental

Arm Description

Dose escalation of Rineterkib added to existing stable dose of ruxolitinib

Arm Title

Part 1 Arm 5: Ruxolitinib + NIS793

Arm Type

Experimental

Arm Description

Safety run-in of NIS793 added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 4: Ruxolitinib + Rineterkib

Arm Type

Experimental

Arm Description

Rineterkib added to existing stable dose of ruxolitinib

Arm Title

Part 2 Arm 5: Ruxolitinib + NIS793

Arm Type

Experimental

Arm Description

NIS793 added to existing stable dose of ruxolitinib

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib

Other Intervention Name(s)

INC424, Jakavi

Intervention Description

5 mg tablets for oral use

Intervention Type

Drug

Intervention Name(s)

Siremadlin

Other Intervention Name(s)

HDM201

Intervention Description

10 mg, 20 mg, or 40 mg capsules for oral use

Intervention Type

Drug

Intervention Name(s)

Crizanlizumab

Other Intervention Name(s)

SEG101

Intervention Description

100 mg/mL concentrate for infusion for intravenous use

Intervention Type

Drug

Intervention Name(s)

Sabatolimab

Other Intervention Name(s)

MBG453

Intervention Description

100 mg/mL or 400 mg/4 mL concentrate for infusion for intravenous use

Intervention Type

Drug

Intervention Name(s)

Rineterkib

Other Intervention Name(s)

LTT462

Intervention Description

100 mg capsule for oral use

Intervention Type

Drug

Intervention Name(s)

NIS793

Intervention Description

700 mg/7 mL concentrate for intravenous use

Primary Outcome Measure Information:

Title

Incidence of dose limiting toxicities within the first 2 cycles

Description

Incidence and severity of dose limiting toxicities within the first 2 cycles (6 or 8 weeks) in Part 1 of the study

Time Frame

Baseline to the end of Cycle 2 (6 or 8 weeks)

Title

Response rate at the end of cycle 6 or cycle 8

Description

Time Frame

Baseline to the end of Cycle 6 or 8 (24 weeks)

Secondary Outcome Measure Information:

Title

Percentage of subjects achieving an improvement in hemoglobin level of ≥ 1.5 g/dL from baseline

Description

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 1.5 g/dL from baseline at each time point in Part 2 and Part 3 of the study.

Time Frame

Baseline to the end of Cycle 6 or 8 (24 weeks), and end of Cycle 12 or 16 (48 weeks)

Title

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 2.0 g/dL from baseline

Description

Percentage of subjects achieving an improvement in hemoglobin level of at least >= 2.0 g/dL from baseline at each time point in Part 2 and Part 3 of the study.

Time Frame

Baseline to the end of Cycle 6 or 8 (24 weeks), and end of Cycle 12 or 16 (48 weeks)

Title

Change in spleen length from baseline

Description

Change in spleen length measured in centimeters by manual palpation summarized at each time point using descriptive statistics in Part 1 (core and extension), Part 2 and Part 3 of the study

Time Frame

Baseline to day 1 and day 15 of Cycle 1, 2 and 3, day 1 of all subsequent cycles, and the end of 12 or 16 cycles (48 weeks)

Title

Change in spleen volume from baseline

Description

Time Frame

Baseline to the end of Cycle 6 or 8 (24 weeks), the end of Cycle 12 or 16 (48 weeks) and at the end of treatment if not performed in the past 12 weeks (up to 48 weeks)

Title

Change in symptoms of MFSAF v4.0 from baseline

Description

Time Frame

Baseline to day 1 of Cycle 1, day 1 of all subsequent cycles of treatment (each cycle is 28 days except for arms containing NIS793, which are 21 days), as well as the end of treatment visit (approximately 52 weeks)

Title

Change in symptoms of EORTC QLQ-C30 from baseline

Description

Time Frame

Title

Changes in symptoms in MFSAF v4.0 (Part 1) from baseline

Description

Time Frame

Baseline to end of Cycle 3 or 4 (week 16), and end of Cycle 6 or 8 (week 24weeks), or end Cycle 12 or 16 (48 weeks)

Title

Progression free survival, per progressive splenomegaly, accelerated phase, deteriorating cytopenia, leukemic transformation or death from any cause

Description

Time Frame

Baseline to disease progression, which is up to 24 weeks for Part 1 or through study completion, an average of 1 year, for Part 2 and Part 3

Title

Percentage of subjects achieving an improvement in bone marrow fibrosis of ≥ 1 grade from baseline

Description

Percentage of subjects achieving an improvement in bone marrow fibrosis of >= 1 grade at each time point will be summarized in Part 2 and Part 3 of the study.

Time Frame

Baseline to the end of Cycle 6 or 8 (24 weeks), the end of Cycle 12 or 16 (48 weeks) and at the end of treatment if not performed in the past 12 weeks (up to 48 weeks)

Title

Area under the Plasma Concentration versus Time Curve (AUC)

Description

AUC for each investigational drug in Part 1, Part 2 and Part 3 of the study

Time Frame

Days 1 and 5 of Cycle 1 and 2 for siremadlin and ruxolitinib, and Cycle 1 and Cycle 3 for crizanlizumab, sabatolimab and NIS793, and Days 1 and 15 of Cycle 1 for LTT462

Title

Maximum (peak) observed plasma drug concentration (Cmax)

Description

Cmax for each investigational drug in Part 1, Part 2 and Part 3 of the study

Time Frame

Days 1 and 5 of Cycle 1 and 2 for siremadlin and ruxolitinib, and Cycle 1 and Cycle 3 for crizanlizumab, sabatolimab and NIS793, and Days 1 and 15 of Cycle 1 for LTT462

Title

Time to reach maximum (peak) plasma, blood, serum or other body fluid drug concentration after single dose administration (Tmax)

Description

Tmax for each investigational drug in Part 1, Part 2 and Part 3 of the study

Time Frame

Days 1 and 5 of Cycle 1 and 2 for siremadlin and ruxolitinib, and Cycle 1 and Cycle 3 for crizanlizumab, sabatolimab and NIS793, and Days 1 and 15 of Cycle 1 for LTT462

Title

Concentration versus time profile

Description

Concentration versus time profile for each investigational drug in Part 1, Part 2 and Part 3 of the study

Time Frame

Days 1 and 5 of Cycle 1 and 2 for siremadlin and ruxolitinib, and Cycle 1 and Cycle 3 for crizanlizumab, sabatolimab and NIS793, and Days 1 and 15 of Cycle 1 for LTT462

Title

Presence and/or concentration of anti-drug antibody

Description

The presence and titer of anti-drug antibodies for crizanlizumab, sabatolimab and NIS793 in Part 1, Part 2 and Part 3 of the study

Time Frame

Baseline to 105 days after last study drug administration for crizanlizumab, to 150 days after last study drug administration for sabatolimab, or to 90 days after last study drug administration for NIS793

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Core treatment phase Inclusion Criteria: Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria Palpable spleen of at least 5 cm from the left costal margin (LCM) to the point of greatest splenic protrusion or enlarged spleen volume of at least 450 cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first dose of study treatment can be accepted). Have been treated with ruxolitinib for at least 12 weeks prior to first dose of study treatment Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between 5 and 25 mg twice a day (BID)) for ≥ 4 weeks prior to first dose of study treatment Extension treatment phase inclusion criteria: Signed consent for the extension treatment phase ongoing in the core treatment phase demonstrates clinical benefit of treatment in core treatment phase per investigator's assessment. Core treatment phase Exclusion Criteria: Not able to understand and to comply with study instructions and requirements. Received any investigational agent for the treatment of MF (except ruxolitinib) within 30 days of first dose of study treatment or within 5 half-lives of the study treatment, whichever is greater Peripheral blood blasts count of > 10%. has documented severe hypersensitivity reactions/immunogenicity (IG) to a prior biologic product or Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1 year of screening in NIS793, crizanlizumab or sabatolimab arms, or in rineterkib or siremadlin arms within <=4 weeks of screening or <=5 half-lives whichever is shorter Splenic irradiation within 6 months prior to the first dose of study drug Received blood platelet transfusion within 28 days prior to first dose of study treatment. Extension treatment phase Exclusion Criteria: meets any of study treatment discontinuation criteria current evidence of treatment failure per investigator, following treatment in core treatment phase enrolled in another interventional study evidence of non-compliance to study procedures or withdrew consent in core treatment phase currently has unresolved toxicities for which study treatment has been interrupted in the core treatment phase local access to alternative myelofibrosis treatment including those currently under investigation in clinical trials as assessed suitable in the opinion of the investigator. Other protocol-defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68305

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Novartis Investigative Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

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Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (ADORE)

Myelofibrosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial