A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours
1 other identifier
observational
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2011
Longer than P75 for all trials
1 active site
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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 3, 2013
May 1, 2013
3 years
May 23, 2011
May 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue.
Analysis
1 year
Secondary Outcomes (1)
To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics
1 Year
Study Arms (1)
Advanced solid tumours
Interventions
Eligibility Criteria
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.
You may qualify if:
- Advanced Solid Tumor
You may not qualify if:
- Non advanced solid tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, Singapore
Related Publications (2)
Yu H, Jove R. The STATs of cancer--new molecular targets come of age. Nat Rev Cancer. 2004 Feb;4(2):97-105. doi: 10.1038/nrc1275. No abstract available.
PMID: 14964307BACKGROUNDBuettner R, Mora LB, Jove R. Activated STAT signaling in human tumors provides novel molecular targets for therapeutic intervention. Clin Cancer Res. 2002 Apr;8(4):945-54.
PMID: 11948098BACKGROUND
Biospecimen
Blood samples
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
June 3, 2013
Study Start
May 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2015
Last Updated
June 3, 2013
Record last verified: 2013-05