Advanced or Metastatic Solid Tumours Clinical Trial
Official title:
Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Verified date | February 2014 |
Source | Aptose Biosciences Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Aptose Biosciences Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. | 8 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05021120 -
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
|
Early Phase 1 | |
Recruiting |
NCT03658070 -
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours
|
Phase 1 |