AzTrials
AzTrials

Multiple MyelomaPhase 1NCT03710915

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

A Phase 1 study testing HG146 in people with Multiple Myeloma and Relapsed and Refractory Multiple Myeloma, run by HitGen Inc. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
What is being tested?
HG146
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
12 Jan 2019to 28 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • HitGen Inc

    Chengdu, Sichuan, 610200

Other trials in China

About this study

Official title: A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma

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

Read the detailed description

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.

Being tested
HG146
Keywords
HDAC inhibitor, Dose escalation, HG146
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HG146Drug

    Also called HG280146, HG0146, HG280146, HG280146-P1

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

Study groups in NCT03710915
Study groupRoleWhat they receive
HG146 capsule treat multiple myelomaExperimentalExperimental: 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
Receives: Drug: HG146

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of HG146

    To determine the maximum tolerated dose of HG146 in relapsed and refractory multiple myeloma patients.

    Measured: Up to 3 months

Secondary outcomes (6)

  1. Peak Plasma Concentration (Cmax)

    To determine the Peak Plasma Concentration of HG146.

    Measured: In cycle 1 (each cycle is 21 days)

  2. Area under the plasma concentration versus time curve (AUC)

    To determine the Area under the plasma concentration versus time curve of HG146.

    Measured: In the middle of cycle 1 (each cycle is 21 days)

  3. Time of Peak Concentration (Tmax)

    To determine the time of peak concentration of HG146.

    Measured: In the middle of cycle 1 (each cycle is 21 days)

  4. Half life (T1/2)

    To determine the half-life of HG146.

    Measured: In the middle of cycle 1 (each cycle is 21 days)

  5. Incidence of adverse events related to treatments

    To evaluate the incidence of adverse events that are related to treatments in relapsed and refractory myeloma patients.

    Measured: Up to 21 days after last dose

  6. Incidence of laboratory abnormalities related to treatments

    To evaluate the incidence of laboratory abnormalities that are related to treatments in relapsed and refractory myeloma patients.

    Measured: Up to 1 month after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start12 Jan 2019
  3. Primary completion28 Sep 2022
  4. Study completion28 Jun 2023

Why it stopped: Company decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
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
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03710915
Sponsor's protocol ID
HG146-I-CRP-1.0
Status last verified
Sep 2023
First submitted
29 Sep 2018
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang B, Lu J, Wang X, Xiao Y, Zhao Y, Huang H, Liu J, Chen M, Gu J, Yuan S, Zheng D, Li Y, Huang X, Li J. Prognostic value of lactate dehydrogenase in Chinese patients with newly diagnosed transplant eligible multiple myeloma. Leuk Lymphoma. 2017 Jul;58(7):1740-1742. doi: 10.1080/10428194.2016.1252975. Epub 2016 Nov 23. No abstract available.

    PubMed 27881052

  • Lu J, Lu J, Chen W, Huo Y, Huang X, Hou J; Chinese Medical Doctor Association Hematology Branch. Clinical features and treatment outcome in newly diagnosed Chinese patients with multiple myeloma: results of a multicenter analysis. Blood Cancer J. 2014 Aug 15;4(8):e239. doi: 10.1038/bcj.2014.55.

    PubMed 25127393

  • Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.

    PubMed 25439696

  • Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer. 1975 Sep;36(3):842-54. doi: 10.1002/1097-0142(197509)36:33.0.co;2-u.

    PubMed 1182674

  • Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, Richardson P, Caltagirone S, Lahuerta JJ, Facon T, Bringhen S, Gay F, Attal M, Passera R, Spencer A, Offidani M, Kumar S, Musto P, Lonial S, Petrucci MT, Orlowski RZ, Zamagni E, Morgan G, Dimopoulos MA, Durie BG, Anderson KC, Sonneveld P, San Miguel J, Cavo M, Rajkumar SV, Moreau P. Revised International Staging System for Multiple Myeloma: A Report From International Myeloma Working Group. J Clin Oncol. 2015 Sep 10;33(26):2863-9. doi: 10.1200/JCO.2015.61.2267. Epub 2015 Aug 3.

    PubMed 26240224

  • Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.

    PubMed 28106903

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HG146 in people with Multiple Myeloma and Relapsed and Refractory Multiple Myeloma, run by HitGen Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of HG146 (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03710915, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in