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A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT03934567
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Xynomic Pharmaceuticals, Inc.

Brief Summary:
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)

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

Detailed Description:
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Abexinostat 80 mg bis in die (BID)
Experimental: Abexinostat 80 mg BID
Drug: Abexinostat
Abexinostat tablets




Primary Outcome Measures :
  1. Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review [ Time Frame: up to 56 days ]
    Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) as assessed by an Independent Central Imaging Review


Secondary Outcome Measures :
  1. Objective Response [ Time Frame: up to 56 days ]
    Objective response rate (ORR) as assessed by the investigator

  2. Progression-free survival [ Time Frame: Up to 2 years ]
    Progression-free survival (PFS), defined as the time from the initiation of treatment to disease progression or death as assessed by the Independent Central Imaging Review and the investigator



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:

  1. Life expectancy ≥ 3 months
  2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
  3. Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)
  4. Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy
  5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  7. Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria:

  1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
  2. Current or history of central nervous system (CNS) lymphoma;
  3. Toxicity not yet recovered from previous anti-tumor therapies
  4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
  5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
  6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
  7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
  8. Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose
  9. Presence of active graft-versus-host disease
  10. Have undergone a major surgery within 28 days
  11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
  12. Have cardiac impairment as defined per protocol
  13. Have prior history of malignancies other than follicular lymphoma

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): NCT03934567


Contacts
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Contact: Bing Zhao, MD (01186)13716386801 bing.zhao@xynomicpharma.com
Contact: Sophia Paspal, Ph.D. RAC 610-405-5974 sophia.paspal@xynomicpharma.com

Sponsors and Collaborators
Xynomic Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Yuankai SHI, Prof Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Xynomic Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03934567     History of Changes
Other Study ID Numbers: XYN-605
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Xynomic Pharmaceuticals, Inc.:
refractory
relapsed
lymph nodes

Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
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