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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02503033




Registration number
NCT02503033
Ethics application status
Date submitted
13/07/2015
Date registered
20/07/2015

Titles & IDs
Public title
A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies
Scientific 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
Secondary ID [1] 0 0
2015-523-00AU1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematologic Malignancies 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL-523

Experimental: HMPL-523 - Oral 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.


Treatment: Drugs: HMPL-523
Oral administration, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
dose limited toxicities evaluated with NCI CTCAE v4.03
Timepoint [1] 0 0
within 28days after the first dose
Secondary outcome [1] 0 0
maximum plasma concentration calculated with Blood samples
Timepoint [1] 0 0
within 29 days after the first dose
Secondary outcome [2] 0 0
time to reach maximum concentration calculated with Blood samples
Timepoint [2] 0 0
within 29 days after the first dose
Secondary outcome [3] 0 0
Objective response rate
Timepoint [3] 0 0
within 30 days after the last dose
Secondary outcome [4] 0 0
adverse events evaluated by NCI CTCAE v4.03
Timepoint [4] 0 0
from the first dose to within 30days after the last dose

Eligibility
Key inclusion criteria
1. Signed Informed Consent Form.
2. Ability to comply with the protocol.
3. Age>=18 years.
4. ECOG performance status of 0 or 1.
5. 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.
6. 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.
7. 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.
8. Expected survival of more than 24 weeks as determined by the investigator.
9. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with primary CNS lymphoma.
2. Known active central nervous system or leptomeningeal lymphoma.
3. Any of the following laboratory abnormalities:

1. Absolute neutrophil count<1.5×109/L
2. Hemoglobin <80g/L.
3. 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.
4. Inadequate organ function, defined by the following:

1. 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.
2. 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.
3. Serum creatinine > 1.5 the ULN or estimated creatinine clearance < 50 mL/min.
4. Serum amylase or lipase > the ULN.
5. Triglycerides and/or cholesterol >1.5 the ULN.
6. 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.
5. 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).
6. Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment.
7. Herbal therapy =1 week prior to initiation of study treatment.
8. Prior use of any anti-cancer vaccine.
9. Prior treatment with any SYK inhibitors (e.g. Fostamatinib).
10. Prior administration of radioimmunotherapy 3 months prior to initiation of study treatment.
11. 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).
12. Adverse events from prior anti-cancer therapy that have not resolved to Grade =1, except for alopecia.
13. Prior autologous transplant within 6 months prior to first dose of study drug.
14. 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.
15. Clinically significant active infection (pneumonia)
16. Major surgical procedure within 4 weeks prior to initiation of study treatment.
17. 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.
18. Pregnant (positive pregnancy test) or lactating women.
19. New York Heart Association (NYHA) Class II or greater congestive heart failure.
20. Congenital long QT syndrome or QTc > 450 msec.
21. Currently use medication known to cause QT prolongation or Torsades de Pointes (http:// www.crediblemeds.org)
22. History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment.
23. History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment.
24. Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease.
25. Image evidence of gallstone or other bile duct disease within 6 months prior to initiation of study treatment.
26. Treatment within a clinical study within 30 days prior to initiation of study treatment.
27. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2021
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Townsville Hospital - Townsville
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Ballarat Regional Integrated Cancer Centre - Ballarat
Recruitment hospital [7] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [9] 0 0
Barwon Health - Geelong
Recruitment hospital [10] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
Cabrini Health - Melbourne
Recruitment hospital [12] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2640 - Albury
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
4814 - Townsville
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
3350 - Ballarat
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
- Heidelberg
Recruitment postcode(s) [11] 0 0
3144 - Melbourne
Recruitment postcode(s) [12] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hutchison Medipharma Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chen Yu, MD
Address 0 0
Hutchison Medi Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02503033