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A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced 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: NCT01867073
Recruitment Status : Unknown
Verified May 2013 by National University Hospital, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date May 23, 2011
First Posted Date June 3, 2013
Last Update Posted Date June 3, 2013
Study Start Date May 2011
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2013)
Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue. [ Time Frame: 1 year ]
Analysis
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 27, 2013)
To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics [ Time Frame: 1 Year ]
Analysis
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours
Official Title Not Provided
Brief Summary OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical Company, Ltd, and is currently undergoing clinical investigation at the National University Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic biomarker study is initiated and funded by the investigators, and will be conducted in conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic samples will be collected, stored and analysed at the local laboratory of the study site (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population The study will enroll patients from the extension cohort an ongoing phase I study of OPB51602, to study the tumour response in selected tumour types, as a proof of concept.
Condition Advanced Solid Tumors
Intervention Other: Biomarker
Study Groups/Cohorts Advanced solid tumours
Intervention: Other: Biomarker
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 27, 2013)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2015
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Advanced Solid Tumor

Exclusion Criteria:

Non advanced solid tumor

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT01867073
Other Study ID Numbers PG01/04/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National University Hospital, Singapore
Study Sponsor National University Hospital, Singapore
Collaborators Not Provided
Investigators Not Provided
PRS Account National University Hospital, Singapore
Verification Date May 2013