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Hematologic MalignanciesPhase 1NCT02503033

A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing HMPL-523 in people with Hematologic Malignancies, run by Hutchison Medipharma Limited at 12 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered to patients with relapsed or refractory Hematologic Malignancies To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the dose limited toxicities associated with HMPL-523 when administered to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Malignancies
What is being tested?
HMPL-523
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
12 sitesAustralia
Study dates
Nov 2015to Mar 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form.
  • Ability to comply with the protocol.
  • Age>=18 years.
  • ECOG performance status of 0 or 1.
  • Histologically relapsed or refractory chronic lymphocytic leukemia, lymphoma, multiple myeloma(MM) In the dose expansion stage, the tumor types are restricted to relapsed or refractory CLL/SLL, MCL, FL (Grade 1-3a), MZL and WM/LPL.
  • Have failed at least one prior therapy or patients who are unable to tolerate standard therapy or no curative therapy or therapy of higher priority exists.
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  • In the dose-expansion stage, patients must have measurable disease for objective response assessment.
  • NOTE: measurable disease with FL, MCL, MZL, LPL, or SLL defined as at least 1 bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by computerized tomography [CT] scan)., as defined in appendix 9.
  • Expected survival of more than 24 weeks as determined by the investigator.
  • Male or female patients of child-bearing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), contraceptives (oral or parenteral), Implanon®, injectables or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment. Post-menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.

Who cannot join

  • Patients with primary CNS lymphoma.
  • Known active central nervous system or leptomeningeal lymphoma.
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count<1.5×109/L
  • Hemoglobin <80g/L.
  • Platelet<75 ×109/L. NOTE: in expansion stage patients with cell counts below the thresholds listed above may be considered eligible if in the investigators opinion the reason is believed to be due to bone marrow infiltration. The investigator will discuss the eligibility of such patients with the sponsor and only upon approval (confirmed in writing) by the sponsor will a patient be enrolled in the study.
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  • Inadequate organ function, defined by the following:
  • Total bilirubin >1.5the ULN with the following exception:
  • Patients with known Gilbert disease who have serum bilirubin level ≤3 the ULN and normal AST/ALT may be enrolled.
  • AST and/or ALT > 2.5 the ULN with the following exception:Patients with documented disease infiltration of the liver may have AST and/or ALT levels ≤ 5 the ULN.
  • Serum creatinine > 1.5 the ULN or estimated creatinine clearance < 50 mL/min.
  • Serum amylase or lipase > the ULN.
  • Triglycerides and/or cholesterol >1.5 the ULN.
  • International normalized ratio (INR)>1.5 the ULN or activated partial thromboplastin time (aPTT)>1.5 the ULN.
  • For patients requiring anticoagulation therapy with warfarin, a stable INR between 2-3 is required. If anticoagulation is required for a prosthetic heart valve, then INR should be between 2.5-3.5 for eligibility NOTE: patients may be considered for the study if liver or kidney function is impaired, but this impairment is believed to be a result of the patient's underlying disease. The investigator will discuss the eligibility of such patients with the Sponsor and only upon approval (confirmed in writing) by the Sponsor will a patient be enrolled in the study.
  • Subjects with presence of clinically detectable second primary malignant tumors at enrollment, or other malignant tumors within the last 2 years (with the exception of radically treated basal cell or squamous cell carcinoma of the skin, in situ cervix, or in situ breast cancer).
  • Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment.
  • Herbal therapy ≤1 week prior to initiation of study treatment.
  • Prior use of any anti-cancer vaccine.
  • Prior treatment with any SYK inhibitors (e.g. Fostamatinib).
  • Prior administration of radioimmunotherapy 3 months prior to initiation of study treatment.
  • Taking strong CYP3A inhibitors, and inducers and drugs metabolized by CYP3A, 2B6 and 1A2 that are identified as narrow therapeutic drugs within 7 days or 3 half-lives, whichever is longer, prior to administration of the first dose of study drug (refer to Appendix 15).
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1, except for alopecia.
  • Prior autologous transplant within 6 months prior to first dose of study drug.
  • Prior allogeneic stem cell transplant within 6 months prior to initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to initiation of study treatment.
  • Clinically significant active infection (pneumonia)
  • Major surgical procedure within 4 weeks prior to initiation of study treatment.
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
  • Active infection is defined as requiring treatment with antiviral therapy or presence of positive test results for hepatitis B (hepatitis B surface antigen and/or total hepatitis B core antibody) or HCV antibody.
  • Patients who test positive for hepatitis B core antibody are eligible only if test results are also positive for hepatitis B surface antibody and polymerase chain reaction (PCR) is negative for HBV DNA.
  • Patients who are positive for HCV serology are only eligible if testing for HCV RNA is negative.
  • Pregnant (positive pregnancy test) or lactating women.
  • New York Heart Association (NYHA) Class II or greater congestive heart failure.
  • Congenital long QT syndrome or QTc > 450 msec.
  • Currently use medication known to cause QT prolongation or Torsades de Pointes (http:// www.crediblemeds.org)
  • History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment.
  • History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment.
  • Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease.
  • Image evidence of gallstone or other bile duct disease within 6 months prior to initiation of study treatment.
  • Treatment within a clinical study within 30 days prior to initiation of study treatment.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Australia12 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Ballarat Regional Integrated Cancer Centre

    Ballarat, Victoria, 3350

  • Canberra Hospital

    Canberra, Australian Capital Territory

  • St Vincent's Hospital

    Fitzroy, Victoria

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria

  • Barwon Health

    Geelong, Victoria, 3220

  • Austin Hospital

    Heidelberg, Victoria

  • Liverpool Hospital

    Liverpool, New South Wales

  • Cabrini Health

    Melbourne, Victoria, 3144

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Townsville Hospital

    Townsville, Queensland, 4814

Other trials in Australia

About this study

Official title: A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered to patients with relapsed or refractory Hematologic Malignancies

To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the dose limited toxicities associated with HMPL-523 when administered to patients with relapsed or refractory Hematologic Malignancies

Read the detailed description

There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2).

Dose-escalation stage (stage 1). The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. Approximately 18 to 27 evaluable patients will be enrolled. The actual number of patients depends on the dose limited toxicities situation as well as the maximum tolerated dosage reached at this stage.

Dosing will include QD (quaque die) and bis in die (BID) cohorts. A cycle of study treatment will be defined as 28 days of continuous dosing.

Dose-expansion stage (stage 2). In this stage, approximately 40 patients with B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia will be enrolled with 600mg once daily as starting dose. The tumor types of the expansion stage are restricted to Chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Follicular Lymphoma (FL) (Grade 1-3a), Marginal zone lymphoma (MZL) and Waldenstrom's macroglobulinemia / Lymphoplasmacytic lymphoma (WM/LPL). Subjects will receive HMPL-523 600mg once daily with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first.

Being tested
HMPL-523
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • HMPL-523Drug

    Oral administration, once daily

Study groups in NCT02503033
Study groupRoleWhat they receive
HMPL-523ExperimentalOral administration, at a dose of 100, 200, 400, 600, 800 and 1000mg once daily or 300mg and 400mg twice daily at Dose-escalation stage. At the Dose-expansion stage, HMPL-523 600mg will be dosed once daily.
Receives: Drug: HMPL-523

What is being measured

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

  1. dose limited toxicities evaluated with NCI CTCAE v4.03

    Incidence of dose limited toxicities and associated dose of HMPL-523

    Measured: within 28days after the first dose

Secondary outcomes (4)

  1. maximum plasma concentration calculated with Blood samples

    Blood samples will be taken to measure the levels of study drug

    Measured: within 29 days after the first dose

  2. time to reach maximum concentration calculated with Blood samples

    Blood samples will be taken to measure the levels of study drug

    Measured: within 29 days after the first dose

  3. Objective response rate

    the proportion of subjects who have a Complete Response or Partial Response

    Measured: within 30 days after the last dose

  4. adverse events evaluated by NCI CTCAE v4.03

    Incidence of adverse events and associated dose of HMPL-523

    Measured: from the first dose to within 30days after the 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 posted20 Jul 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2020 (estimated)
  4. Study completionMar 2021 (estimated)

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
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02503033
Sponsor's protocol ID
2015-523-00AU1
Status last verified
Sep 2020
First submitted
13 Jul 2015
Last updated
11 Sep 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMPL-523 in people with Hematologic Malignancies, run by Hutchison Medipharma Limited at 12 sites in Australia.

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 10 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Australia. 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?

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?

dose limited toxicities evaluated with NCI CTCAE v4.03 (time frame: within 28days after the first dose). 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 NCT02503033.

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 11 Sep 2020.

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