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

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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)

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate

Secondary Outcome

 Objective Response Rate by disease subtype

Condition

Adult T-Cell Lymphoma (ATL)

Intervention

HBI-8000

Study Arms / Comparison Groups

 HBI-8000
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

23

Start Date

November 2016

Completion Date

November 2019

Primary Completion Date

December 2018

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gloria Lee, MD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02955589

Organization ID

HBI-8000-210


Responsible Party

Sponsor

Study Sponsor

HUYA Bioscience International

Collaborators

 Quintiles, Inc.

Study Sponsor

Gloria Lee, MD, Study Chair, HUYA Bioscience International, LLC


Verification Date

October 2020