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Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

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ClinicalTrials.gov Identifier: NCT03600441
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Xynomic Pharmaceuticals, Inc.

Brief Summary:
This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Abexinostat Phase 2

Detailed Description:
Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Abexinostat
Abexinostat tablets will be administered orally at 80 mg (4 × 20 mg tablets) BID (twice a day) 4 hours apart for 7 days in a "one week on, one week off" schedule (on Days 1 to 7 and Days 15 to 21 of each 28-day cycle).
Drug: Abexinostat
Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.




Primary Outcome Measures :
  1. Clinical effect of abexinostat [ Time Frame: Time frame up to 100 months ]
    Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months. ]
    Duration of response defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve an objective response, according to the Lugano 2014 criteria as determined by an IRC.

  2. Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Defined as the time from the start of treatment until disease progression or death assessed using the Lugano 2014 criteria as determined by an IRC.

  3. Clinical Benefit [ Time Frame: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months. ]
    Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC.

  4. Overall survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Defined as the time from the start of treatment until death from any cause or last contact.

  5. Duration of response [ Time Frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Defined as the time from first documented evidence of CR or PR from any cause among patients who achieve an objective response, according to the RECIL 2017 as determined by an IRC. Duration of response will be evaluated once more using the RECIL 2017 with the inclusion of Minor Response (MR) lasting ≥ 6 months.

  6. Incidence of adverse events [ Time Frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Safety as measured by the incidence of adverse events

  7. Incidence of serious adverse events [ Time Frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Safety as measured by the serious of adverse events (SAE)

  8. Incidence of non-serious adverse events [ Time Frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Safety as measured by the non-serious of adverse events

  9. Change in the interval corrected for heart rate (QTc) interval [ Time Frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Change from baseline in the QTc interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
  • Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma.
  • Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy radiologically measuring ≥ 3 cm in its longest diameter).
  • Female patients must fulfil the following criteria:

    a. Be of non-childbearing potential, defined as follows: i. Postmenopausal (ie, ≥ 1 year without any menses) prior to Screening, or ii. Documented surgically sterile (≥ 1 month prior to Screening)

  • Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
  • Use highly effective forms of birth control (women of childbearing potential only), which include the following:

    i. Consistent and correct use of established oral contraception ii. Established intrauterine device or intrauterine system iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

  • Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
  • Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose.
  • Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.

Exclusion Criteria:

  • Has diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma
  • Has a history of central nervous system lymphoma (either primary or secondary).
  • Has had prior treatment with abexinostat.
  • Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment
  • Has any types of cardiac impairment at the time of enrollment
  • Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer
  • Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600441


Contacts
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Contact: Virgil Rose, MD +1 919 456 6615 virgil.Rose@ppdi.com
Contact: Chasey Zhang chasey.zhang@xynomicpharma.com

Locations
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United States, Illinois
Advocate Medical Group - Park Ridge, Luther Lane - Oncology Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Hanna Mendyuk    847-410-0667    hanna.mendyuk@advocatehealth.com   
Contact: Kathy Tolzien    (847) 470-0658    kathy.tolzien@advocatehealth.com   
Principal Investigator: Jacob Bitran, MD         
United States, Kentucky
Norton Cancer Institute - St. Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
Contact: Heather Woolridge    502-899-3366 ext 19281    heather.woolridge@nortonhealthcare.org   
Contact: Dana Haycraft, RN    (502) 899-3366 ext 187    dana.haycraft@nortonhealthcare.org   
Principal Investigator: Don Stevens, MD         
United States, New York
Clinical Research Alliance Inc Recruiting
Lake Success, New York, United States, 11042
Contact: Regina Murawski    516-488-2918 ext 114    rmurawski@researchcra.com   
Contact: Victoria Travers    (516) 488-2918 ext 114    vtravers@researchcra.com   
Principal Investigator: Morton Coleman, MD         
Manhattan Hematology Oncology Center Recruiting
New York, New York, United States, 10016
Contact: Peter Okpara    212-689-6791    pokpara@mhony.com   
Principal Investigator: Karen Haglof, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Chelsea Nichols    646-449-1311    nicholsc@mskcc.org   
Contact: Stephanie DeFrank    (646) 449-1304    defranks@mskcc.org   
Principal Investigator: Connie Batlevi, MD         
United States, Pennsylvania
Bone Marrow Transplant Hematology Oncology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15224-2156
Contact: Melissa McMillen, RN    412-578-4493    melissa.mcmillen@ahn.org   
Contact: Rich Wonder, RN    (412) 578-4492    Rich.Wonder@ahn.org   
Principal Investigator: John Lister, MD         
United States, Texas
Arlington Cancer Center Recruiting
Arlington, Texas, United States, 76012
Contact: Lisa Carson    817-261-4906 ext 1371    lisacarson@texashealth.org   
Contact: Suzette Clark    (214) 483-6933      
Principal Investigator: Alfred DiStefano, MD         
Central Texas Veterans Health Care System - NAVREF Recruiting
Temple, Texas, United States, 76504
Contact: Michelle Kaspick    254-743-1226    april.kaspick@va.gov   
Contact: Renae Noriega    (254) 899-7525    renae.noriega@va.gov   
Principal Investigator: Juan Posada, MD         
United States, Washington
Vista Oncology Inc. PS Recruiting
Olympia, Washington, United States, 98506
Contact: Yun Li, RN, MSCR, MBBS    3608103625    yunli@vista-oncology.com   
Principal Investigator: Joseph Ye         
France
Centre Hospitalier de Perpignan Recruiting
Perpignan, Pyrénées-Orientales, France, 66046
Contact: Fatima Touhami    +33468618902    fatima.touhami@ch-perpignan.fr   
Contact: Kévin Quesada    +33468618902    kevin.quesada@ch-perpignan.fr   
Principal Investigator: Laurence Sanhes, MD         
Spain
Hospital Universitario de Donostia Recruiting
Donostia-San Sebastián, Guipúzcoa, Spain, 20014
Contact: Brigida Esteban Arranz, BSc    +34943007572    brigida.estebanarranz2@osakidetza.eus   
Contact: Gloria Nuñez Rueda    +34943007572    gloria.nunezrueda@osakidetza.eus   
Principal Investigator: Izaskun Ceberio Echechipia, MD         
Hospital Universitario Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Contact: Queralt Ferrer    +34932746100 ext 4976    qferrer@vhio.net   
Contact: Elena Sanchez Cuartielles    +34 93 274 60 00 ext 4976    esanchezcuartielles@vhio.net   
Principal Investigator: Pau Abrisqueta, MD         
Hospital del Mar Recruiting
Barcelona, Spain, 28229
Contact: Francesc Garcia    +34932483343    fgarcia1@imim.es   
Principal Investigator: Antonio Salar Silvestre, MD         
C.H. Regional Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Juan Miguel Serra Galasco    +34957736053    juanmiguelserragalaso@gmail.com   
Contact: Inmaculada Ruiz Caceres, BSc    +34957736053    datamanager1hurs@yahoo.com   
Principal Investigator: Joaquín Sánchez García, MD         
Hospital Universitario Infanta Leonor Recruiting
Madrid, Spain, 28031
Contact: Raquel Fernandez Ordoño    +34911918932    raquel.fernandezo@salud.madrid.org   
Contact: Maria Angeles Rodriguez-Calderita    +34911918508    marodriguezcalderita@salud.madrid.org   
Principal Investigator: Jose Angel Hernandez Rivas, MD         
Sponsors and Collaborators
Xynomic Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Connie W Batlevi, MD,PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Xynomic Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03600441     History of Changes
Other Study ID Numbers: XYN-601
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xynomic Pharmaceuticals, Inc.:
cancer

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Abexinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action