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Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

Primary Purpose

Adult T-Cell Lymphoma (ATL)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
HBI-8000
Sponsored by
HUYABIO International, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult T-Cell Lymphoma (ATL)

Eligibility Criteria

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

Inclusion Criteria:

  1. Histopathological, or cytological diagnosis of ATL confirmed as seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody
  2. Acute, lymphoma or unfavorable chronic types. The unfavorable chronic type is defined by the presence of at least 1 of the following: serum albumin <3.5 g/dL, lactic dehydrogenase (LDH) >300 U/L, or blood urea nitrogen (BUN) >25 mg/dL. The patient must have at least 1 of measurable lesion, or evaluable lesion in either of peripheral blood or skin
  3. Relapsed or refractory disease after receiving prior systemic therapy with mogamulizumab, or ≥1 prior systemic therapy with cytotoxic chemotherapy in case of intolerance/contraindication for mogamulizumab. And there is no other available treatment which can be considered appropriate for patients
  4. Male or female, aged 20 years or older
  5. ECOG Performance Status of 0-2
  6. Life expectancy of greater than 3 months
  7. Meeting the following laboratory criteria for screening:

    • Absolute Neutrophil Count >1500/µL independent of growth factor support within 7 days of starting the study drug
    • Platelets >75,000/µL independent of transfusion within 14 days of starting the study drug
    • Hgb >8 g/dL independent of transfusion within 14 days of starting the study drug
    • Serum creatinine < upper limit of normal (ULN)
    • Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamyl pyruvic transaminase (ALT/SGPT) less than or equal to 3 X ULN
    • Serum Bilirubin less than or equal to 1.5 X ULN
  8. Negative serum pregnancy test for females of childbearing (reproductive) potential. Female patients of child bearing potential must use an effective method of birth control (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide) during treatment period and 1 month thereafter; Males must use an effective method of birth control (2 barrier methods) during treatment period and 3 months thereafter.

    Note: Female patients will be considered to be women of childbearing potential unless having undergone permanent contraception or postmenopausal. Postmenopausal is defined as at least 12 months without menses with no other medical reasons (e.g., chemical menopause because of treatment with anti-malignant tumor agents).

  9. Signed informed consent

Exclusion Criteria:

2.5.2 Exclusion Criteria:

  1. Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm)
  2. Male patients with QTcF > 450 msec at screening, female patients with QTcF > 470 msec at screening, or patients with congenital long QT syndrome, clinically significant arrhythmia, history of congestive heart failure (New York Heart Association Class III or IV) or acute myocardial infarction within 6 months of starting the study drug at screening.
  3. Patients with known hypersensitivity to benzamide class of compounds or any of the components of HBI-8000 tablets, and patients with prior exposure of HBI-8000;
  4. Patients with a history of second malignancy other than disease under study. The exceptions are disease that has been treated with curative intent with no evidence of recurrence in past 2 years including:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Cervical carcinoma in situ
    • Carcinoma in situ of the breast
    • An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
    • Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection
  5. Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug
  6. History of allogeneic stem cell transplantation
  7. Organ transplantation recipients except autologous hematopoietic stem cell transplantation
  8. Uncontrolled inter-current infection
  9. Hepatitis B surface antigen-positive, or hepatitis C virus antibody positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen negative, a hepatitis B virus DNA test (real-time PCR measurement) should be performed and if positive, the patient should be excluded from study
  10. Any history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  11. Uncontrolled diabetes mellitus, hypertension, endocrine disorder, bleeding disorder
  12. Major surgery or radiation therapy within 28 days of starting the study drug
  13. Receiving investigational agents or anti-cancer therapy within 28 days, nitrosourea or mitomycin C within 42 days, of starting the study drug
  14. Receiving antibody therapy for ATL within 12 weeks of starting the study drug
  15. Women who are breastfeeding or women who are not willing to stop breastfeeding during study treatment period and for 30 days after the last dose of study drug
  16. Potential for non-compliance or at increased risk based on investigator's judgement

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HBI-8000

Arm Description

Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Objective Response Rate by disease subtype
Median duration of progression-free survival (PFS)
Median duration of response (DOR)

Full Information

First Posted
November 1, 2016
Last Updated
October 2, 2020
Sponsor
HUYABIO International, LLC.
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02955589
Brief Title
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
Official Title
A Phase 2b Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HUYABIO International, LLC.
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)
Detailed Description
This is a Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3 to 4 days between dosing. A treatment cycle is defined as 28 consecutive days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult T-Cell Lymphoma (ATL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBI-8000
Arm Type
Experimental
Arm Description
Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
HBI-8000
Intervention Description
Oral, twice weekly
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Until disease progression or unacceptable toxicity, assessed up to 18 months
Secondary Outcome Measure Information:
Title
Objective Response Rate by disease subtype
Time Frame
Until disease progression or unacceptable toxicity, assessed up to 18 months
Title
Median duration of progression-free survival (PFS)
Time Frame
Until disease progression or unacceptable toxicity, assessed up to 18 months
Title
Median duration of response (DOR)
Time Frame
Until disease progression or unacceptable toxicity, assessed up to 18 months
Other Pre-specified Outcome Measures:
Title
Median duration of overall survival (OS)
Time Frame
Until disease progression or unacceptable toxicity, assessed up to 18 months
Title
Safety and tolerability, evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
30 ± 3 days after the last dosing of the study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathological, or cytological diagnosis of ATL confirmed as seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody Acute, lymphoma or unfavorable chronic types. The unfavorable chronic type is defined by the presence of at least 1 of the following: serum albumin <3.5 g/dL, lactic dehydrogenase (LDH) >300 U/L, or blood urea nitrogen (BUN) >25 mg/dL. The patient must have at least 1 of measurable lesion, or evaluable lesion in either of peripheral blood or skin Relapsed or refractory disease after receiving prior systemic therapy with mogamulizumab, or ≥1 prior systemic therapy with cytotoxic chemotherapy in case of intolerance/contraindication for mogamulizumab. And there is no other available treatment which can be considered appropriate for patients Male or female, aged 20 years or older ECOG Performance Status of 0-2 Life expectancy of greater than 3 months Meeting the following laboratory criteria for screening: Absolute Neutrophil Count >1500/µL independent of growth factor support within 7 days of starting the study drug Platelets >75,000/µL independent of transfusion within 14 days of starting the study drug Hgb >8 g/dL independent of transfusion within 14 days of starting the study drug Serum creatinine < upper limit of normal (ULN) Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamyl pyruvic transaminase (ALT/SGPT) less than or equal to 3 X ULN Serum Bilirubin less than or equal to 1.5 X ULN Negative serum pregnancy test for females of childbearing (reproductive) potential. Female patients of child bearing potential must use an effective method of birth control (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide) during treatment period and 1 month thereafter; Males must use an effective method of birth control (2 barrier methods) during treatment period and 3 months thereafter. Note: Female patients will be considered to be women of childbearing potential unless having undergone permanent contraception or postmenopausal. Postmenopausal is defined as at least 12 months without menses with no other medical reasons (e.g., chemical menopause because of treatment with anti-malignant tumor agents). Signed informed consent Exclusion Criteria: 2.5.2 Exclusion Criteria: Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm) Male patients with QTcF > 450 msec at screening, female patients with QTcF > 470 msec at screening, or patients with congenital long QT syndrome, clinically significant arrhythmia, history of congestive heart failure (New York Heart Association Class III or IV) or acute myocardial infarction within 6 months of starting the study drug at screening. Patients with known hypersensitivity to benzamide class of compounds or any of the components of HBI-8000 tablets, and patients with prior exposure of HBI-8000; Patients with a history of second malignancy other than disease under study. The exceptions are disease that has been treated with curative intent with no evidence of recurrence in past 2 years including: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Cervical carcinoma in situ Carcinoma in situ of the breast An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b) Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug History of allogeneic stem cell transplantation Organ transplantation recipients except autologous hematopoietic stem cell transplantation Uncontrolled inter-current infection Hepatitis B surface antigen-positive, or hepatitis C virus antibody positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen negative, a hepatitis B virus DNA test (real-time PCR measurement) should be performed and if positive, the patient should be excluded from study Any history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Uncontrolled diabetes mellitus, hypertension, endocrine disorder, bleeding disorder Major surgery or radiation therapy within 28 days of starting the study drug Receiving investigational agents or anti-cancer therapy within 28 days, nitrosourea or mitomycin C within 42 days, of starting the study drug Receiving antibody therapy for ATL within 12 weeks of starting the study drug Women who are breastfeeding or women who are not willing to stop breastfeeding during study treatment period and for 30 days after the last dose of study drug Potential for non-compliance or at increased risk based on investigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Lee, MD
Organizational Affiliation
HUYA Bioscience International, LLC
Official's Role
Study Chair
Facility Information:
City
Fukuoka
Country
Japan
City
Isehara
Country
Japan
City
Kagoshima
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Maebashi
Country
Japan
City
Miyazaki
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Oita
Country
Japan
City
Okayama
Country
Japan
City
Omura
Country
Japan
City
Osakasayama
Country
Japan
City
Saga
Country
Japan
City
Sapporo
Country
Japan
City
Suita
Country
Japan
City
Tokyo
Country
Japan
City
Yamagata
Country
Japan
City
Yufu
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

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