TriangleNCT02953652 · REGISTRY CONDITION SEARCH
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2024-09-19
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate
Objective Response Rate by Disease Subtype
Median Duration of Progression-free Survival (PFS)
Median Duration of Response (DOR)
Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0
Median Duration of Overall Survival (OS)
Pharmacokinetics (Cmax-selected Sites)
Pharmacokinetics AUC (0-INF)
Pharmacokinetics AUC (0-tau)
t 1/2
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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: 1. PTCL, NOS 2. Angioimmunoblastic T-cell lymphoma (AITL) 3. Anaplastic large-cell lymphoma (ALCL), ALK+ 4. Anaplastic large-cell lymphoma (ALCL), ALK- 5. Enteropathy-associated T-cell lymphoma (EATL) 6. Hepatosplenic T-cell lymphoma 7. Subcutaneous panniculitis-like T-cell lymphoma 2. 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. 3. 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. 4. Male or female, age 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: 1. Absolute Neutrophil Count \>1500/µL independent of growth factor support within 7 days of starting the study drug 2. Platelets \>75,000/µL independent of transfusion within 14 days of starting the study drug 3. Hgb \>8 g/dL independent of transfusion within 14 days of starting the study drug 4. Serum creatinine \< 1.5 X ULN 5. Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamyl pyruvic transaminase (ALT/SGPT) less than or equal to 3 X ULN 6. 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: 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: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Cervical carcinoma in situ 4. Carcinoma in situ of the breast 5. An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b) 6. Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection 7. Thyroid cancer with differentiated histology (e.g. papillary) treated with curative intent 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 PTCL 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
- healthy Volunteers
- false
- minimum Age
- 20 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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 Names
- Drug: HBI-8000
- label
- HBI-8000
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- HBI-8000
- description
- Orally twice weekly
- name
- HBI-8000
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 55
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- Overall survival is defined as the duration from the first dose of study medication to death from any cause.
- measure
- Median Duration of Overall Survival (OS)
- time Frame
- Up to approximately 55 months.
- description
- Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the C1D1 and C2D1 doses.
- measure
- Pharmacokinetics (Cmax-selected Sites)
- time Frame
- 0 (predose) up to 72 hours postdose on C1D1 and 0 (predose) up to 4 hours postdose on C2D1
- description
- Area under the plasma concentration time curve from zero (predose) extrapolated to infinity (ng\*h/mL) (Day 1 only), calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz. Calculated for the C1D1 dose only.
- measure
- Pharmacokinetics AUC (0-INF)
- time Frame
- 0 (predose) up to 72 hours postdose on C1D1
- description
- Area under the plasma concentration time curve over the dosing interval tau (ng\*h/mL), calculated by linear up/log down trapezoidal summation. Calculated for the C1D1 dose only. Actual elapsed sampling time at tau and the corresponding plasma concentration was used in the calculation of this parameter. If concentrations fall to BLQ before or at tau, AUCall (area under the plasma concentration time curve from zero \[predose\] to the time of the last observation within the dosing interval, calculated by linear up/log down trapezoidal summation) was used as the estimate of this parameter.
- measure
- Pharmacokinetics AUC (0-tau)
- time Frame
- 0 (predose) up to 72 hours postdose on C1D1
- description
- Apparent terminal half-life (h), calculated as (ln 2)/λz. Calculated for the C1D1 dose only.
- measure
- t 1/2
- time Frame
- 0 (predose) up to 72 hours postdose on C1D1
- primary Outcomes
- description
- Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.
- measure
- Objective Response Rate
- time Frame
- Up to approximately 47 months.
- secondary Outcomes
- description
- Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a CR or a PR according to IWC 2014 criteria and assessed by an IOERC. CR: Target nodes/nodal masses must regress to \<1.5 cm in LDi, no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no BM involvement. PR: ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions. Disease subtype (PTCL-NOS, AITL, ALCL, ALK, EATL) was assessed by Central Pathology Review (CPR).
- measure
- Objective Response Rate by Disease Subtype
- time Frame
- Up to approximately 47 months.
- description
- PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. PD was defined using the IWC 2014 criteria, as any new lesion or an individual node/lesion must be abnormal with: "LDi \>1.5 cm" and "increase by 50% from perpendicular diameters nadir" and "an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5 cm for lesions \<2 cm or 1.0 cm for lesions \>2 cm".
- measure
- Median Duration of Progression-free Survival (PFS)
- time Frame
- Up to approximately 47 months.
- description
- DOR was defined as the duration of response from first response (CR/PR) to disease progression or death, whichever occurs first. CR or PR according to the IWC 2014 criteria was assessed by an IOERC.
- measure
- Median Duration of Response (DOR)
- time Frame
- Up to approximately 47 months.
- description
- Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0. From date of first study drug to 30±3 days after the last dosing of the study drug or before the initiation of new cancer treatment.
- measure
- Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0
- time Frame
- Up to approximately 44 months.
Full 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).
- 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.
Source references
- references
- citation
- Rai S, Kim WS, Ando K, Choi I, Izutsu K, Tsukamoto N, Yokoyama M, Tsukasaki K, Kuroda J, Ando J, Hidaka M, Koh Y, Shibayama H, Uchida T, Yang DH, Ishitsuka K, Ishizawa K, Kim JS, Lee HG, Minami H, Eom HS, Kurosawa M, Lee JH, Lee JS, Lee WS, Nagai H, Shindo T, Yoon DH, Yoshida S, Gillings M, Onogi H, Tobinai K. Oral HDAC inhibitor tucidinostat in patients with relapsed or refractory peripheral T-cell lymphoma: phase IIb results. Haematologica. 2023 Mar 1;108(3):811-821. doi: 10.3324/haematol.2022.280996.
- pmid
- 36200417
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice