Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

NCT01184807 | Completed Phase 1

• 1 other identifier: 266-09-801-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose.

Conditions

Malignant Solid Tumour

Keywords

Advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• safety and tolerability

  AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment

  3 weeks

Secondary Outcomes (3)

• Pharmacokinetics

  duration of the treatment

• safety and tolerability

  duration of treatment

• efficacy

  duration of treatment

Study Arms (1)

OPB-51602

OTHER

Drug: OPB-51602

Interventions

OPB-51602 DRUG

OPB-51602 at a dose of 2, 5, 10, 20, 40, 60, 80, or 100 mg/day,will be orally administered to subjects once daily for 2 weeks in each cycle of treatment in Dose Escalation Stage.A 2-day treatment-free interval will occur on Days 2 and 3 for PK sampling. Study drug administration will resume on Day 4 and continue until Day 17 in cycle 1.In Expansion stage part 1, OPB-51602 will be administered at recommend dose (4mg) for 3 weeks per cycle 9 2 weeks treatment and 1 week washout). There is also 2-day treatment free interval between Day 1 and Day 4 for PK sampling in cycle 1.In Expansion stage part 2, subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in Cycle 1. The same subjects will be treated at MTD(5mg)from cycle 2 onwards for 4 weeks per cycle.

OPB-51602

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically confirmed, locally advanced or metastatic solid tumors who are unresponsive to standard therapy or for whom standard therapy is intolerable or unsuitable
• Age: ≥21 years (at time of informed consent)
• ECOG performance status: ≤2 (Appendix 1)
• Life expectancy of longer than 3 months
• Adequate vital organ function as follows:
• Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin: ≥9.0 g/dL
• Hepatic function Aspartate transaminase (AST) and alanine transaminase(ALT): ≤2.5 ×institutional upper limit of normal(ULN) or ≤5.0 × institutional ULN if there is liver metastasis, serum total bilirubin: \<2.5 × institutional ULN
• Renal function Serum creatinine: \<1.5 × institutional ULN
• Capable of swallowing OPB-51602 tablets
• Ability to understand and willingness to sign written informed consent form (ICF) for participation in the trial
• No chemotherapy, radiotherapy, surgery, immunotherapy, or other therapy within 4 weeks prior to start of investigational medicinal product (IMP) administration and recovered from any prior toxicity
• If a subject has received more than 5 regimens of previous chemotherapy, the investigator must discuss with the sponsor regarding subject suitability prior to enrollment.

You may not qualify if:

• Uncontrolled central nervous system (CNS) metastasis
• Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart Association (NYHA) functional classification)
• Concurrent malignancy of a different type
• Immunocompromised subjects, including those who are known to be infected with human immunodeficiency virus (HIV)
• Psychiatric illness that would limit compliance with trial requirements
• Pregnant or breast-feeding women
• Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who cannot or will not use effective contraceptive measures
• Administration of another investigational agent within 6 weeks prior to start of IMP administration
• Use of any of the prohibited medications and other substances listed in Appendix 3 CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP administration or a period of at least 5 times the respective elimination halflife, whichever is longer
• Known severe gastrointestinal disorder, including malabsorption (at screening)

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (2)

National University Hospital (s) PTE LTD.

Singapore, Singapore, 119074, Singapore

Location

National Cancer Centre, Department of Medical Oncology

Singapore, 160610, Singapore

Location

Related Publications (1)

• Wong AL, Soo RA, Tan DS, Lee SC, Lim JS, Marban PC, Kong LR, Lee YJ, Wang LZ, Thuya WL, Soong R, Yee MQ, Chin TM, Cordero MT, Asuncion BR, Pang B, Pervaiz S, Hirpara JL, Sinha A, Xu WW, Yuasa M, Tsunoda T, Motoyama M, Yamauchi T, Goh BC. Phase I and biomarker study of OPB-51602, a novel signal transducer and activator of transcription (STAT) 3 inhibitor, in patients with refractory solid malignancies. Ann Oncol. 2015 May;26(5):998-1005. doi: 10.1093/annonc/mdv026. Epub 2015 Jan 21.

  PMID: 25609248 DERIVED

Study Officials

• Goh Boon Cher, Dr

  Department of Haematology-Oncology,National University Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Tan shao Weng, MD, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

SG (2)