Advanced or Metastatic Solid Tumours
Conditions
Brief summary
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
Interventions
DRUGLOR-253 HCl
LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.
Sponsors
Aptose Biosciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years of age or older. 2. Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy. 3. Meet laboratory parameter requirements at study entry.
Exclusion criteria
1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl. 2. A hematologic malignancy. 3. A history of brain or other central nervous system metastases. 4. Have a presence of a significant infection. 5. Clinically significant autoimmune disease. 6. Uncontrolled intercurrent illness. 7. With iron or copper overload syndromes. 8. Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. | 8 weeks |
Countries
United States
Outcome results
None listed