A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2023-06-28

Brief Summary

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This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

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Detailed Description

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This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human.

This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.

Conditions

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Multiple Myeloma Relapsed and Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Drug: HG146 capsule HG146 capsule is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.

Other Name: HG280146, HG0146, HG280146, HG280146-P1

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HG146 capsule treat multiple myeloma

Experimental: 5/10/15/20 mg HG146 capsule 5 mg starting dose taken orally on Day 1, 3, 5, 7, 9, 11, 13 of each cycle, and off drug for 8 days (3 weeks).

Intervention: Drug: HG146 capsule

Group Type EXPERIMENTAL

HG146

Intervention Type DRUG

HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.

Interventions

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HG146

HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.

Intervention Type DRUG

Other Intervention Names

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HG280146, HG0146, HG280146, HG280146-P1

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of multiple myeloma requiring systemic therapy (International Myeloma Working Group \[IMWG\]) and 2 cycles of treatment including proteasome inhibitors and/or immunomodulators.
* Serum M protein≥ 10.0g / L, or urine M protein ≥ 200mg / 24h.
* Not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
* Expected survival of ≥3 months.
* Hemoglobin ≥ 80 g/L, Platelet≥75×10\^9/L, Absolute Neutrophil Count≧1.0×109/L (1000 cells/mm3), Prothrombin time(PT) and activated partial thromboplastin time ≤ 2 x Upper Limit of Normal (ULN).
* Bilirubin in serum\<1.5\*ULN (2.0mg/dL/20mg/L/34.2μmol/L); glutamic-pyruvic transaminase (ALT) and/or Aspartate Aminotransferase (AST)≤3\*ULN (upper limit of normal).
* Normal electrocardiogram, echocardiography and myocardial enzyme spectrumCalibration of blood calcium concentration≤ULN.
* Men and women, Non-pregnant women who did not consider giving birth during the trial or five years after the end of the trial.
* The patient is able to swallow the capsule.
* Patients must provide written consent.

Exclusion Criteria

* Severe allergies to the study drug or any of its excipients.
* The possibility of gene toxicity, mutagenesis and teratogenicity.
* Men and women who did not have sperm or egg cells stored in vitro before the trial and who planned to have children again within five years.
* Pregnant or lactating women.
* Perform autologous bone marrow transplantation 3 months before admission.
* Receive allogeneic bone marrow transplantation.
* Use HDAC inhibitors before.
* Two weeks prior to admission, received radiotherapy or bone marrow suppressive chemotherapy or biological treatment.
* Patients with history of other malignant tumors, except the tumor is in remission and has not been treated for at least 5 years.
* Patients with dysphagia or oral absorption disorder.
* The investigators determine the conditions not suitable for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No