A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 25, 2014
February 1, 2014
2.5 years
January 20, 2011
February 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.
8 weeks
Study Arms (1)
LOR-253 HCl
EXPERIMENTALLOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female 18 years of age or older.
- Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
- Meet laboratory parameter requirements at study entry.
You may not qualify if:
- Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
- A hematologic malignancy.
- A history of brain or other central nervous system metastases.
- Have a presence of a significant infection.
- Clinically significant autoimmune disease.
- Uncontrolled intercurrent illness.
- With iron or copper overload syndromes.
- Pregnancy or breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Cercek, M.D.
Memorial Sloan Kettering Cancer Center
- PRINCIPAL INVESTIGATOR
Jennifer Wheler, MD
M.D. Anderson Cancer Center
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
January 20, 2011
First Posted
January 24, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2013
Study Completion
January 1, 2014
Last Updated
February 25, 2014
Record last verified: 2014-02