A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours

• Sponsor: National University Hospital, Singapore (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01867073
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 48
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
Advanced Solid Tumors	Other: Biomarker

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2011
• Anticipated Primary Completion Date: May 1, 2014
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Advanced solid tumours	Other: Biomarker

Outcome Measures

Primary Outcome Measures

1. Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue. [1 year]

   Analysis

Secondary Outcome Measures

1. To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics [1 Year]

   Analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Advanced Solid Tumor

Exclusion Criteria:

Non advanced solid tumor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University Hospital	Singapore		Singapore

Sponsors and Collaborators

• National University Hospital, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Buettner 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. Review.
• Yu H, Jove R. The STATs of cancer--new molecular targets come of age. Nat Rev Cancer. 2004 Feb;4(2):97-105. Review.

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT01867073
• Other Study ID Numbers: PG01/04/11
• First Posted: Jun 3, 2013
• Last Update Posted: Jun 3, 2013
• Last Verified: May 1, 2013

Study Results

No Results Posted as of Jun 3, 2013