search
Back to results

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

Primary Purpose

Follicular Lymphoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abexinostat
Sponsored by
Xynomic Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring cancer

Eligibility Criteria

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

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

Sites / Locations

  • Advocate Medical Group - Park Ridge, Luther Lane - Oncology
  • Norton Cancer Institute - St. Matthews Campus
  • Clinical Research Alliance Inc
  • Manhattan Hematology Oncology Center
  • Memorial Sloan Kettering Cancer Center
  • Bone Marrow Transplant Hematology Oncology Associates
  • Arlington Cancer Center
  • Central Texas Veterans Health Care System - NAVREF
  • Vista Oncology Inc. PS
  • Centre Hospitalier de Perpignan
  • Hospital Universitario de Donostia
  • Hospital Universitario Vall d'Hebrón
  • Hospital del Mar
  • C.H. Regional Reina Sofia
  • Hospital Universitario Infanta Leonor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abexinostat

Arm Description

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).

Outcomes

Primary Outcome Measures

Clinical effect of abexinostat
Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).

Secondary Outcome Measures

Duration of response
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.
Progression free survival
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.
Clinical Benefit
Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC.
Overall survival
Defined as the time from the start of treatment until death from any cause or last contact.
Duration of response
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.
Incidence of adverse events
Safety as measured by the incidence of adverse events
Incidence of serious adverse events
Safety as measured by the serious of adverse events (SAE)
Incidence of non-serious adverse events
Safety as measured by the non-serious of adverse events
Change in the interval corrected for heart rate (QTc) interval
Change from baseline in the QTc interval.

Full Information

First Posted
June 23, 2018
Last Updated
August 18, 2022
Sponsor
Xynomic Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03600441
Brief Title
Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
Acronym
FORERUNNER
Official Title
Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xynomic Pharmaceuticals, Inc.

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abexinostat
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Abexinostat
Intervention Description
Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
Primary Outcome Measure Information:
Title
Clinical effect of abexinostat
Description
Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
Time Frame
Time frame up to 100 months
Secondary Outcome Measure Information:
Title
Duration of response
Description
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.
Time Frame
At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
Title
Progression free survival
Description
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.
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
Title
Clinical Benefit
Description
Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC.
Time Frame
At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
Title
Overall survival
Description
Defined as the time from the start of treatment until death from any cause or last contact.
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
Title
Duration of response
Description
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.
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
Title
Incidence of adverse events
Description
Safety as measured by the 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
Title
Incidence of serious adverse events
Description
Safety as measured by the serious of adverse events (SAE)
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
Title
Incidence of non-serious adverse events
Description
Safety as measured by the non-serious 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
Title
Change in the interval corrected for heart rate (QTc) interval
Description
Change from baseline in the 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie W Batlevi, MD,PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Norton Cancer Institute - St. Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Clinical Research Alliance Inc
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Manhattan Hematology Oncology Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Bone Marrow Transplant Hematology Oncology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-2156
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Central Texas Veterans Health Care System - NAVREF
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Vista Oncology Inc. PS
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
State/Province
Pyrénées-Orientales
ZIP/Postal Code
66046
Country
France
Facility Name
Hospital Universitario de Donostia
City
Donostia-San Sebastián
State/Province
Guipúzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
28229
Country
Spain
Facility Name
C.H. Regional Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.fda.gov/Safety/Recalls/
Description
FDA Safety Alerts

Learn more about this trial

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

We'll reach out to this number within 24 hrs