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

NCT02503033 | Unknown Phase 1

• 1 other identifier: 2015-523-00AU1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 12

Brief 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 patients with relapsed or refractory Hematologic Malignancies

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• dose limited toxicities evaluated with NCI CTCAE v4.03

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

  within 28days after the first dose

Secondary Outcomes (4)

• maximum plasma concentration calculated with Blood samples

  within 29 days after the first dose

• time to reach maximum concentration calculated with Blood samples

  within 29 days after the first dose

• Objective response rate

  within 30 days after the last dose

• adverse events evaluated by NCI CTCAE v4.03

  from the first dose to within 30days after the last dose

Study Arms (1)

HMPL-523

EXPERIMENTAL

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.

Drug: HMPL-523

Interventions

HMPL-523 DRUG

Oral administration, once daily

HMPL-523

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead
• Iqvia Pty Ltd: collaborator

Study Sites (12)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Location

Border Medical Oncology Research Unit

Albury, New South Wales, 2640, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, Australia

Location

Townsville Hospital

Townsville, Queensland, 4814, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Ballarat Regional Integrated Cancer Centre

Ballarat, Victoria, 3350, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, Australia

Location

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Austin Hospital

Heidelberg, Victoria, Australia

Location

Cabrini Health

Melbourne, Victoria, 3144, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Chen Yu, MD

  Hutchison Medi Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 20, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

AU (12)