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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

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).

Condition or disease Intervention/treatment
Advanced Solid Tumors Other: Biomarker

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015

Group/Cohort Intervention/treatment
Advanced solid tumours Other: Biomarker



Primary Outcome Measures :
  1. Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue. [ Time Frame: 1 year ]
    Analysis


Secondary Outcome Measures :
  1. To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics [ Time Frame: 1 Year ]
    Analysis


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

Advanced Solid Tumor

Exclusion Criteria:

Non advanced solid tumor


Information from the National Library of Medicine

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): NCT01867073


Locations
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Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Publications:
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01867073    
Other Study ID Numbers: PG01/04/11
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013