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Trial record 24 of 1147 for:    "Follicular lymphoma"

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

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ClinicalTrials.gov Identifier: NCT03600441
Recruitment Status : Active, not recruiting
First Posted : July 25, 2018
Last Update Posted : July 11, 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 : 139 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, 2020
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


Locations
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United States, Illinois
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Norton Cancer Institute - St. Matthews Campus
Louisville, Kentucky, United States, 40207
United States, New York
Clinical Research Alliance Inc
Lake Success, New York, United States, 11042
Manhattan Hematology Oncology Center
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Bone Marrow Transplant Hematology Oncology Associates
Pittsburgh, Pennsylvania, United States, 15224-2156
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Central Texas Veterans Health Care System - NAVREF
Temple, Texas, United States, 76504
United States, Washington
Vista Oncology Inc. PS
Olympia, Washington, United States, 98506
France
Centre Hospitalier de Perpignan
Perpignan, Pyrénées-Orientales, France, 66046
Spain
Hospital Universitario de Donostia
Donostia-San Sebastián, Guipúzcoa, Spain, 20014
Hospital Universitario Vall d'Hebrón
Barcelona, Spain, 08035
Hospital del Mar
Barcelona, Spain, 28229
C.H. Regional Reina Sofia
Córdoba, Spain, 14004
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
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: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Follicular
Lymphoma
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