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Trial record 1 of 1 for:    NCT03779113
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An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779113
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2).

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: HMPL-523 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients With Relapsed or Refractory Lymphoma
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Treatment
All patients to received study drug (HMPL-523)
Drug: HMPL-523
Oral HMPL-523




Primary Outcome Measures :
  1. Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 [ Time Frame: From first dose to within 30 days after the last dose ]
    The safety and tolerability of HMPL-523 will be evaluated based on adverse events data.


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: From Cycle 1, Day 1, 5 min pre-dose 1st dose until Cycle 1, Day 28 8 hours post-dose. ]
    To Characterize the pharmacokinetic properties of HMPL-523 in patients with relapsed or refractory lymphoma

  2. Area under the concentration-time curve in a selected time interval (AUC0-t) [ Time Frame: From Cycle 1, Day 1, 5 min pre-dose 1st dose until Cycle 1, Day 28 8 hours post-dose. ]
    To characterize the pharmacokinetic properties of HMPL-523 in patients with relapsed or refractory lymphoma

  3. Objective response rate (ORR) defined as the proportion of patients who have a CR or PR [ Time Frame: From first dose to within 30 days after the last dose ]
    To evaluate the anti-tumor activity of HMPL-523 in patients with relapsed or refractory lymphoma according to: (1) Chronic Lymphocytic Leukemia (CLL) - modified International Workshop on CLL guidelines, (2) Waldenstrom's Macroglobulinemia (WM) - consensus of international workshops on WM, (3) Lymphomas other than CLL or WM: Lugano Response Criteria for Hodgkin and Non-Hodgkin's Lymphoma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form
  2. Age ≥18 years
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Histologically confirmed lymphoma, including Hodgkin's lymphoma and non-Hodgkin's lymphoma a. In the dose expansion stage, the tumor types are restricted to relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, mantel cell lymphoma, follicular lymphoma (Grade 1-3a), marginal zone lymphoma, and Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma.
  5. Patients with relapsed or refractory lymphoma who have exhausted approved therapy options
  6. In the dose expansion stage, patients must have measurable disease for objective response assessment, except for patients with chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma.
  7. Expected survival of more than 24 weeks as determined by the investigator
  8. Male or female patients of child-bearing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (oral or parenteral), Implanon®, injectables, or other measures to avoid pregnancy during the study and for 90 days after the last day of treatment. Post-menopausal females (>50 years old and without menses for >1 year) and women who are surgically postmenopausal are exempt from this criterion.

Exclusion Criteria:

  1. Patients with primary central nervous system lymphoma
  2. Any of the following laboratory abnormalities: Absolute neutrophil count <1.5×109/L, Hemoglobin <80 g/L, Platelets <75 ×109/L
  3. Inadequate organ function, defined by the following: Total bilirubin >1.5 times the upper limit of normal (× ULN), aspartate aminotransferase and/or alanine aminotransferase >2.5 × ULN, Estimated Creatinine Clearance (CrCl) per Cockcroft-Gault [Dose Escalation portion of trial (Stage 1) CrCl < 50 mL/min, Dose Expansion portion of trial (Stage 2) CrCl < 30 mL/min], Serum amylase or lipase >ULN, International normalized ratio >1.5 × ULN, or activated partial thromboplastin time >1.5 × ULN
  4. Patients with 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)
  5. Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment
  6. Herbal therapy within 1 week prior to initiation of study treatment
  7. Prior use of any anti-cancer vaccine
  8. Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib)
  9. Prior administration of radioimmunotherapy within 3 months before initiation of study treatment
  10. Use of strong cytochrome P450 isoform 3A inhibitors and inducers and drugs metabolized by cytochrome P450 isoform 3A, cytochrome P450 isoform 2B6, and cytochrome P450 isoform 1A2, and are identified as narrow therapeutic drugs within 7 days or 3 half-lives, whichever is longer, prior to initiation of study treatment
  11. Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
  12. Prior autologous stem cell transplant within 6 months prior to initiation of study treatment
  13. 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
  14. Clinically significant active infection (eg, pneumonia)
  15. Major surgical procedure within 4 weeks prior to initiation of study treatment
  16. Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
  17. Pregnant (positive serum beta human chorionic gonadotropin test) or lactating women
  18. New York Heart Association Class II or greater congestive heart failure
  19. Congenital long QT syndrome or correct QT interval using Fridericia's formula (QTcF) >480 msec
  20. Currently use medication known to cause QT prolongation or Torsades de Pointes
  21. History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
  22. History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment
  23. Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
  24. Treatment in a clinical study within 30 days prior to initiation of study treatment
  25. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779113


Contacts
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Contact: Tunde Lawrence, MD, PhD 973-786-2789 tundel@hmplglobal.com
Contact: Alisha Khullar 973-287-3081 alishak@hmplglobal.com

Locations
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United States, California
Compassionate Care Research Group Recruiting
Fountain Valley, California, United States, 92708
Contact: Barbara Lepthien    714-698-0300      
Principal Investigator: Haresh Jhangiani, MD         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jill Roemmich    864-455-3600    jRoemmich@ghs.org   
Principal Investigator: Elizabeth Cull, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gloria Martinez    877-632-6789    gkmartinez@mdanderson.org   
Principal Investigator: Paolo Strati, MD         
United States, Washington
Northwest Medical Specialities Recruiting
Tacoma, Washington, United States, 98405
Contact: Linda Dhaene    253-428-8700    LDhaene@nwmsonline.com   
Principal Investigator: Jorge Chaves, MD         
Italy
Ospedale San Raffaele Not yet recruiting
Milan, Italy
Contact: Daniela DeLorenzo       delorenzo.daniela@hsr.it   
Principal Investigator: Andres Ferreri, MD         
Poland
KO-MED Centra Kliniczne Not yet recruiting
Biała Podlaska, Poland
Contact: Dominika Chwedoruk       dominika.chwedoruk@komed-ck.pl   
Principal Investigator: Piotr Centkowski, MD         
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdańsk, Poland
Contact: Michal Taszner       mtaszner@uck.gda.pl   
Principal Investigator: Michal Taszner, MD         
BioResearch Group Sp. Z. o. o. Recruiting
Kajetany, Poland
Contact: Marta Marek       m.marek@bioresearch.pl   
Principal Investigator: Katarzyna Jarus-Dziedzic, MD         
Pratia McM Recruiting
Kraków, Poland
Contact: Anna Saweic, MD       anna.sawiec@pratia.com   
Principal Investigator: Wojciech Jurczak, MD         
Nasz Lekarz Przychodnie Medyczne Recruiting
Toruń, Poland
Contact: Judyta Rudzinska       j.rudzinska@naszlekarz.pl   
Principal Investigator: Dominik Chraniuk         
Spain
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Mafalda Rodrigues       amafaldanrodrigues@vhio.net   
Principal Investigator: Pau Abrisqueta, MD         
Institut Català d'Oncologia Not yet recruiting
Barcelona, Spain
Contact: Anna Valer Serra         
Contact: avaler@iconcologia.net         
Principal Investigator: Eva Gonzalez Barca, MD         
Fundacion Jimenez Diaz Not yet recruiting
Madrid, Spain
Contact: Adriana Armellini       adriana.armellini@startmadrid.com   
Principal Investigator: Raul Cordoba, MD         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Study Director: Tunde Lawrence, MD, PhD Hutchison Medipharma Limited
Principal Investigator: Nathan Fowler, MD MD Anderson
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03779113    
Other Study ID Numbers: 2018-523-US001
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
lymphoma
mantle cell
marginal zone
waldenstrom
chronic lymphocytic leukemia
follicular
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases