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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Primary Purpose

Myelofibrosis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Selinexor
Selinexor
Placebo
Ruxolitinib
Sponsored by
Karyopharm Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring Myelofibrosis, Selinexor, Ruxolitinib, Janus kinase 2, Myeloproliferative neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of primary MF or post-essential thrombocythemic or post-polycythemia according to the 2016 world health organization (WHO) classification of MPN confirmed by the most recent local pathology report.
  • Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 cubic centimeter (cm^3) by MRI or CT-scan.
  • Participants with dynamic international prognostic scoring system (DIPSS) risk category of intermediate-1, intermediate-2, or high-risk.
  • Participants ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (≤) 2.
  • Platelet count ≥100 * 10^9/Liter (L).
  • Absolute neutrophil count (ANC) ≥1.5 * 10^9/L.
  • Serum direct bilirubin ≤1.5 * upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 * ULN.
  • Creatinine clearance (CrCl) greater than (>) 15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula.
  • Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is less than (<) 100 international units/milliliter (IU/mL).
  • Participants with untreated hepatitis C virus (HCV) are eligible there is documentation of negative viral load per institutional standard.
  • Participants with history of human immunodeficiency virus (HIV), are eligible if participants have cluster of differentiation 4 (CD4)+ T-cell counts ≥350 cells/microliter, negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
  • Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for one month following the last dose of study treatment. Childbearing potential excludes: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy.
  • Male participants who are sexually active must use highly effective methods of contraception throughout the study and for one month following the last dose of study treatment. Must agree not to donate sperm during the study treatment period.
  • Participants must sign the written informed consent in accordance with federal, local and institutional guidelines.

Exclusion Criteria:

  • >5% blasts in peripheral blood or >10% blasts in bone marrow (accelerated phase).
  • Received previous treatment with Janus kinase (JAK) inhibitors for MF (treatment with hydroxyurea for up to 2 weeks is allowed).
  • Previous treatment with selinexor or other exportin-1 (XPO1) inhibitors.
  • Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor.
  • Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing.
  • Major surgery <28 days prior to cycle 1 day 1 (C1D1).
  • Uncontrolled (i.e. clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, prevent the patient from giving informed consent, or being compliant with the study procedures.
  • Female participants who are pregnant or lactating.

Sites / Locations

  • City of HopeRecruiting
  • The Oncology Institute of Hope & Innovation
  • OhioHealthRecruiting
  • Vanderbilt Ingram Cancer Center
  • Huntsman Cancer Institute
  • VCU Massey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID

Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID

Phase 1b: Selinexor and Ruxolitinib BID

Phase 3: Selinexor 60 mg + Ruxolitinib BID

Phase 3: Placebo + Ruxolitinib BID

Arm Description

Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.

Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.

Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.

Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.

Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.

Outcomes

Primary Outcome Measures

Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24
Phase 3: Proportion of Participants with Total Symptom Score (TSS) Reduction of >= 50% (TSS50) at Week 24 Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0
Phase 1: Maximum Tolerated Dose (MTD)
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity

Secondary Outcome Measures

Phase 3: Proportion of Participants with Anemia Response at Week 24, as per the International Working Group Myeloproliferative Neoplasms Research and Treatment and European Leukemia Network (IWG-MRT and ELN) criteria
Phase 3: Overall Survival
Phase 3: Overall Response Rate as per IWG-MRT and ELN criteria
Phase 3: Proportion of Participants with SVR35 at any Time Point
Phase 3: Proportion of Participants with TSS50 at any Time as measured by the MFSAF V4.0
Phase 3: SVR35 Response in Participants
Phase 3: TSS50 Response in Participants
Phase 3: Anemia Response in Participants
Phase 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Phase 3: Area Under the Concentration-time Curve (AUC) of Selinexor
Phase 3: Maximum Plasma Concentration (Cmax) of Selinexor
Phase 3: Time at Which Cmax is Achieved (Tmax) of Selinexor
Phase 3: Proportion of Participants with at least Grade 1 Decrease in Bone Marrow Fibrosis
Phase 1: Percentage of Participants with TSS Reduction of >= 50% (TSS50) in the MFSAF V4.0 Based on Local Assessment
Phase 1: Percentage of Participants with Spleen Volume Reduction of >= 25% (SVR25) Based on Local Assessment
Phase 1: Percentage of Participants with Spleen Volume Reduction of >= 35% (SVR35) Based on Local Assessment
Phase 1: Overall Survival
Phase 1: Anaemia Response in Participants as per International Working Group -Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria
Phase 1: Duration of SVR35 Based on Local Assessment
Phase 1: Duration of SVR25 Based on Local Assessment
Phase 1: Duration of TSS50 Based on Local Assessment
Phase 1: Overall Response Rate Based on Local Assessment
Phase 1: Number of Participants with Adverse Events (AEs) by Occurrence, Nature, and Severity
Phase 1: Maximum Plasma Concentration (Cmax) of Selinexor and Ruxolitinib
Phase 1: Area Under the Concentration-time Curve (AUC) of Selinexor and Ruxolitinib

Full Information

First Posted
September 14, 2020
Last Updated
August 30, 2023
Sponsor
Karyopharm Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04562389
Brief Title
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Official Title
A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karyopharm Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
Keywords
Myelofibrosis, Selinexor, Ruxolitinib, Janus kinase 2, Myeloproliferative neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 1, open-label, selinexor dose escalation and expansion part (enrollment completed). Phase 3, randomized, double-blind, placebo-controlled part.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
Arm Type
Experimental
Arm Description
Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.
Arm Title
Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
Arm Type
Experimental
Arm Description
Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Arm Title
Phase 1b: Selinexor and Ruxolitinib BID
Arm Type
Experimental
Arm Description
Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Arm Title
Phase 3: Selinexor 60 mg + Ruxolitinib BID
Arm Type
Experimental
Arm Description
Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Arm Title
Phase 3: Placebo + Ruxolitinib BID
Arm Type
Active Comparator
Arm Description
Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a matching placebo of selinexor oral tablets QW
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Primary Outcome Measure Information:
Title
Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24
Time Frame
At Week 24
Title
Phase 3: Proportion of Participants with Total Symptom Score (TSS) Reduction of >= 50% (TSS50) at Week 24 Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0
Time Frame
At Week 24
Title
Phase 1: Maximum Tolerated Dose (MTD)
Time Frame
Approximately within the first cycle (28 days) of therapy
Title
Phase 1: Recommended Phase 2 Dose (RP2D)
Time Frame
Approximately within the first cycle (28 days) of therapy
Title
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
Time Frame
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Secondary Outcome Measure Information:
Title
Phase 3: Proportion of Participants with Anemia Response at Week 24, as per the International Working Group Myeloproliferative Neoplasms Research and Treatment and European Leukemia Network (IWG-MRT and ELN) criteria
Time Frame
At Week 24
Title
Phase 3: Overall Survival
Time Frame
From date of randomization to the date of death due to any cause or EoS (assessed at approximately 48 months)
Title
Phase 3: Overall Response Rate as per IWG-MRT and ELN criteria
Time Frame
From Cycle 1 Day 1 (28-day cycle) up to EoS (approximately 48 months)
Title
Phase 3: Proportion of Participants with SVR35 at any Time Point
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 3: Proportion of Participants with TSS50 at any Time as measured by the MFSAF V4.0
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 3: SVR35 Response in Participants
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 3: TSS50 Response in Participants
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 3: Anemia Response in Participants
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Time Frame
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Title
Phase 3: Area Under the Concentration-time Curve (AUC) of Selinexor
Time Frame
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2.5 hours post-dose on Cycle 2 Day 15 (28-day cycle)
Title
Phase 3: Maximum Plasma Concentration (Cmax) of Selinexor
Time Frame
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2.5 hours post-dose on Cycle 2 Day 15 (28-day cycle)
Title
Phase 3: Time at Which Cmax is Achieved (Tmax) of Selinexor
Time Frame
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and 2.5 hours post-dose on Cycle 2 Day 15 (28-day cycle)
Title
Phase 3: Proportion of Participants with at least Grade 1 Decrease in Bone Marrow Fibrosis
Time Frame
From Baseline up to EoS (approximately 48 months)
Title
Phase 1: Percentage of Participants with TSS Reduction of >= 50% (TSS50) in the MFSAF V4.0 Based on Local Assessment
Time Frame
From Baseline up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Percentage of Participants with Spleen Volume Reduction of >= 25% (SVR25) Based on Local Assessment
Time Frame
From Baseline up to Week 48
Title
Phase 1: Percentage of Participants with Spleen Volume Reduction of >= 35% (SVR35) Based on Local Assessment
Time Frame
From Baseline up to Week 48
Title
Phase 1: Overall Survival
Time Frame
From Baseline up to 12 months after last dose
Title
Phase 1: Anaemia Response in Participants as per International Working Group -Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria
Time Frame
From Baseline up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Duration of SVR35 Based on Local Assessment
Time Frame
From Baseline up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Duration of SVR25 Based on Local Assessment
Time Frame
From Baseline up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Duration of TSS50 Based on Local Assessment
Time Frame
From Baseline up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Overall Response Rate Based on Local Assessment
Time Frame
Cycle 1 Day 1 (28-day cycle) up to 28 days after last dose (approximately 48 months)
Title
Phase 1: Number of Participants with Adverse Events (AEs) by Occurrence, Nature, and Severity
Time Frame
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Title
Phase 1: Maximum Plasma Concentration (Cmax) of Selinexor and Ruxolitinib
Time Frame
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and Cycle 1 Day 16 (28-day cycle)
Title
Phase 1: Area Under the Concentration-time Curve (AUC) of Selinexor and Ruxolitinib
Time Frame
Predose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 15 and Cycle 1 Day 16 (28-day cycle)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report. Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to screening are acceptable). Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk. Participants >=18 years of age. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2. Platelet count >= 100*10^9/liter (L) without platelet transfusion. Absolute neutrophil count (ANC) >=1.0 *10^9/L without need for growth factors within 7 days prior to C1D1. Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5*upper limit normal (ULN) and serum total bilirubin <= 2 × ULN. Calculated creatinine clearance (CrCl) greater than (>) 15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula. Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for > 8 weeks and the viral load is less than (<) 100 international units/milliliter (IU/mL). Participants with history of hepatitis C virus (HCV) are eligible if they have received adequate curative anti-HCV treatment and HCV viral load is below the limit of quantification. Participants with history of human immunodeficiency virus (HIV) are eligible if they have CD4+ T-cell counts >= 350 cells/microliter (cells/mcL), negative viral load, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year and should be on established antiretroviral therapy (ART) for at least 4 weeks. Female participants of childbearing potential must have a negative serum pregnancy test at screening and within 3 days prior to first dose on C1D1 and agree to use highly effective methods of contraception throughout the selinexor treatment period and for 90 days following the last dose of selinexor treatment. A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Male participants who are sexually active must use highly effective methods of contraception throughout the study treatment period and for 90 days following the last dose of selinexor treatment. Male participants must agree not to donate sperm during the study treatment period and for at least 90 days after the last dose of selinexor treatment. Participants must sign written informed consent in accordance with federal, local, and institutional guidelines. Active symptoms of MF as determined by presence of at least 2 symptoms with a score >=3 or total score of >= 10 at screening using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0. Participant currently not eligible for stem cell transplantation. Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study. Life expectancy of greater than 6 months in the opinion of the investigator. Participants with no other concomitant malignancies or history of another malignancy within 2 years prior to C1D1 except for adequately treated early-stage basal cell or squamous cell carcinoma of skin, adequately treated carcinoma in situ of breast or cervix or organ confined prostate cancer, or PV or ET. Exclusion Criteria: More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase). Previous treatment with JAK inhibitors for MF. Previous treatment with selinexor or other XPO1 inhibitors. Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting or diarrhea > CTCAE v 5.0 Grade 1). Received strong cytochrome P450 3A (CYP3A) inhibitors <= 7 days prior to selinexor dosing OR strong CYP3A inducers <= 14 days prior to selinexor dosing (Phase 1 participants only) Major surgery < 28 days prior to C1D1. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to C1D1; however, prophylactic use of these agents is acceptable (including parenteral). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participants safety, prevent the participant from giving informed consent, or being compliant with the study procedures, or confound the ability to interpret study results. Female participants who are pregnant or lactating. Prior splenectomy, or splenic radiation within 6 months prior to C1D1. Unable or unwilling to undergo CT scan or MRI per protocol. Participants with contraindications or known hypersensitivity to selinexor or ruxolitinib or excipients. History of pulmonary hypertension. History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack [TIA]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class > 2 within 6 months of C1D1. Participants unable to tolerate two forms of antiemetics prior to each dose for at least 2 cycles.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karyopharm Medical Information
Phone
(888) 209-9326
Email
clinicaltrials@karyopharm.com
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haris Ali, MD
Phone
626-356-4673
Email
harisali@coh.org
First Name & Middle Initial & Last Name & Degree
Haris Ali, MD
Facility Name
The Oncology Institute of Hope & Innovation
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basem William
Email
Basem.William@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Basem William
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
VCU Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keri Maher, DO
Phone
760-954-3800
Email
Keri.Maher@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Keri Maher, DO

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

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