Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Sponsor
HUYABIO International, LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT02953652
Collaborator
Quintiles, Inc. (Industry)
40
23
1
63.5
1.7
0

Study Details

Study Description

Brief Summary

Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R PTCL).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Peripheral T-cell Lymphoma (PTCL)
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Feb 17, 2022
Actual Study Completion Date :
Feb 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HBI-8000

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.

Drug: HBI-8000
Orally twice weekly

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate [Until disease progression or unacceptable toxicity up to 12 months]

Secondary Outcome Measures

  1. Objective response rate by disease subtype [Until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption up to 12 months]

  2. Median duration of progression-free survival (PFS) [Until disease progression or unacceptable toxicity up to 18 months]

  3. Median duration of response (DOR) [Until disease progression or unacceptable toxicity up to 18 months]

  4. Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v.4.0 [30 ± 3 days after the last dosing of the study drug]

Other Outcome Measures

  1. Median duration of overall survival (OS) [Until disease progression or unacceptable toxicity up to 18 months]

  2. Pharmacokinetics (selected sites) [28 days]

    Peak Plasma Concentration (Cmax) PK sampling on Cycle 1 Day 1 (C1D1) [pre-dose and 1 h (±15 mins), 2h (±15 mins), 3h (±15 mins), 4h (±15 mins), 5h (±30 mins), and 7h (±30 mins), then 24 ±1, 48 ±1 and 72 ± 1 hours in consenting patients]; and C2D1 [pre-dose and 1 h (±15 mins), 2h (±15 mins), 3h (±15 mins), and 4h (±15 mins)].

  3. Pharmacokinetics (selected sites) [28 days]

    Area under the plasma concentration versus time curve (AUC) PK sampling on Cycle 1 Day 1 (C1D1) [pre-dose and 1 h (±15 mins), 2h (±15 mins), 3h (±15 mins), 4h (±15 mins), 5h (±30 mins), and 7h (±30 mins), then 24 ±1, 48 ±1 and 72 ± 1 hours in consenting patients]; and Cycle 2 Day 1 (C2D1) [pre-dose and 1 h (±15 mins), 2h (±15 mins), 3h (±15 mins), and 4h (±15 mins)].

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histological or cytological diagnosis of the following peripheral T-cell lymphoma (PTCL) subtypes as defined by the WHO classification (2008) may be included:

  2. PTCL, NOS

  3. Angioimmunoblastic T-cell lymphoma (AITL)

  4. Anaplastic large-cell lymphoma (ALCL), ALK+

  5. Anaplastic large-cell lymphoma (ALCL), ALK-

  6. Enteropathy-associated T-cell lymphoma (EATL)

  7. Hepatosplenic T-cell lymphoma

  8. Subcutaneous panniculitis-like T-cell lymphoma

  9. Patients for whom at least 1 measurable lesion is confirmed by the lesion assessment at baseline; an evaluable lesion is defined as more than 1.5 cm in greatest dimension and can be followed by imaging.

  10. Relapsed or refractory disease after receiving ≥1 prior systemic therapy with antitumor agent(s) and there is no other available treatment which can be considered appropriate for patients. Systemic therapy is defined as frontline chemotherapy or immunotherapy administered systemically.

  11. Male or female, age 20 years or older

  12. ECOG Performance Status of 0-2

  13. Life expectancy of greater than 3 months

  14. Meeting the following laboratory criteria for screening:

  15. Absolute Neutrophil Count >1500/µL independent of growth factor support within 7 days of starting the study drug

  16. Platelets >75,000/µL independent of transfusion within 14 days of starting the study drug

  17. Hgb >8 g/dL independent of transfusion within 14 days of starting the study drug

  18. Serum creatinine < 1.5 X ULN

  19. Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamyl pyruvic transaminase (ALT/SGPT) less than or equal to 3 X ULN

  20. Serum Bilirubin less than or equal to 1.5 X ULN

  21. 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)

  1. Signed informed consent
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

  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:

  5. Basal cell carcinoma of the skin

  6. Squamous cell carcinoma of the skin

  7. Cervical carcinoma in situ

  8. Carcinoma in situ of the breast

  9. An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)

  10. Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection

  11. Thyroid cancer with differentiated histology (e.g. papillary) treated with curative intent

  12. Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug

  13. History of allogeneic stem cell transplantation

  14. Organ transplantation recipients except autologous hematopoietic stem cell transplantation

  15. Uncontrolled inter-current infection

  16. 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

  17. Any history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

  18. Uncontrolled diabetes mellitus, hypertension, endocrine disorder, bleeding disorder

  19. Major surgery or radiation therapy within 28 days of starting the study drug

  20. Receiving investigational agents or anti-cancer therapy, within 28 days, nitrosourea or mitomycin C within 42 days of starting the study drug

  21. Receiving antibody therapy for PTCL within 12 weeks of starting the study drug

  22. 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

  23. Potential for non-compliance or at increased risk based on investigator's judgement

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akita Japan
2 Bunkyōku Japan
3 Chūōku Japan
4 Fukuoka Japan
5 Isehara Japan
6 Kagoshima Japan
7 Kobe Japan
8 Kotoku Japan
9 Kumamoto Japan
10 Kyoto Japan
11 Maebashi Japan
12 Nagoya Japan
13 Okayama Japan
14 Osakasayama Japan
15 Sapporo Japan
16 Suita Japan
17 Yamagata Japan
18 Ōmura Japan
19 Busan Korea, Republic of
20 Goyang-si Korea, Republic of
21 Incheon Korea, Republic of
22 Seongnam-si Korea, Republic of
23 Seoul Korea, Republic of

Sponsors and Collaborators

  • HUYABIO International, LLC.
  • Quintiles, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HUYABIO International, LLC.
ClinicalTrials.gov Identifier:
NCT02953652
Other Study ID Numbers:
  • HBI-8000-203
First Posted:
Nov 3, 2016
Last Update Posted:
Jun 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022