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

NCT ID: NCT01867073

Last Updated: 2013-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Advanced Solid Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced solid tumours

Biomarker

Intervention Type OTHER

Interventions

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Biomarker

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Advanced Solid Tumor

Exclusion Criteria

Non advanced solid tumor
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 14964307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11948098 (View on PubMed)

Other Identifiers

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PG01/04/11

Identifier Type: -

Identifier Source: org_study_id

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