A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01281592|
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : February 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumours||Drug: LOR-253 HCl||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||January 2014|
Experimental: LOR-253 HCl
LOR-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.
Drug: LOR-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.
Other Name: No other names are used.
- 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. [ Time Frame: 8 weeks ]
- To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281592
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Andrea Cercek, M.D.||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Jennifer Wheler, MD||M.D. Anderson Cancer Center|