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Clinical Trial Finder

Search Results

A Study to Evaluate Safety and Efficacy of Selinexor in Combination With Ruxolitinib in Participants With Myelofibrosis

Study Purpose

This is a global, Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of selinexor plus ruxolitinib in treatment naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a of the study will be dose escalation (non-randomized dose finding study) to determine the maximum tolerated dose [MTD], recommended Phase 2 dose (RP2D), and evaluate safety and preliminary efficacy and will follow a standard 3+3 design. The Phase 1b of the study will be dose expansion (non-randomized efficacy exploration) at the determined RP2D to further assess the safety and preliminary efficacy at this dose level. The Phase 2 (randomized efficacy exploration) of the study will include MF participants who are treatment naïve randomized 1:1 to receive the combination therapy of selinexor and ruxolitinib versus (vs.#46; ruxolitinib monotherapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04562389
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Karyopharm Therapeutics Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis
Arms & Interventions

Arms

Experimental: Phase 1a: Cohort 1: Selinexor 40 mg and Ruxolitinib 15/20 mg

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

Experimental: Phase 1a: Cohort 2: Selinexor 60 mg and Ruxolitinib 15/20 mg

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

Experimental: Phase 1a: Cohort -1: Selinexor 20 mg and Ruxolitinib 15/20 mg

Participants with MF will receive a dose of 20 mg of selinexor oral tablet twice weekly (BIW) of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.

Experimental: Phase 1b: RP2D: Selinexor and Ruxolitinib 15/20 mg

Participants with MF will receive recommended safe dose (estimated in Phase 1a) of selinexor oral tablets on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.

Experimental: Phase 2: Selinexor RP2D and Ruxolitinib 15/20 mg

Participants with MF will receive recommended safe dose (estimated in Phase 1b) of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle and ruxolitinib oral tablets 15 or 20 mg BID.

Active Comparator: Phase 2: Ruxolitinib 15/20 mg

Participants with MF will receive ruxolitinib oral tablets 15 or 20 mg BID.

Interventions

Drug: - Selinexor

Formulation: 20 mg Tablet; Dose: 20, 40 (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg); Route of Administration: Oral

Drug: - Ruxolitinib

Formulation: 5, 10 mg Tablet; Dose: 15, 20 mg; Route of Administration: Oral

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Haris Ali, MD

harisali@coh.org

626-356-4673

Pasadena, California

Status

Recruiting

Address

The Oncology Institute of Hope & Innovation

Pasadena, California, 91105

Site Contact

Amitabha Mazumder

amazumder@airesearch.us

562-693-4477

Vanderbilt Ingram Cancer Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Sanjay Mohan, MD

sanjay.mohan@vumc.org

615-936-8422

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Srinivas Tantravahi

Srinivas.Tantravahi@hci.utah.edu

801-213-6170

VCU Massey Cancer Center, Richmond, Virginia

Status

Recruiting

Address

VCU Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Keri Maher, DO

Keri.Maher@vcuhealth.org

760-954-3800

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