OPB-51602 in Locally Advanced Nasopharyngeal Carcinoma Prior to Definitive Chemoradiotherapy

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Brief Title

OPB-51602 in Locally Advanced Nasopharyngeal Carcinoma Prior to Definitive Chemoradiotherapy

Official Title

The Signal Transducer and Activator of Transcription (STAT)3 Pathway and the Development of STAT3 Phosphorylation Inhibitors as Cancer Therapy: Lead-In Phase I Dose-Escalating, Open-Label, Non-Randomised Study of A Weekly Regimen OPB-51602 in Advanced Refractory Solid Tumours With Enrichment Cohorts of Nasopharyngeal Carcinoma Followed By A Biomarker Study Evaluating OPB-51602 in Locally Advanced Nasopharyngeal Carcinoma Prior to Definitive Chemoradiotherapy

Brief Summary

      This is a lead-in dose escalation study to determine the safety, tolerability,
      pharmacokinetics, maximum tolerated dose (MTD), and recommended Phase II dose of OPB-51602
      administered on a weekly basis in subjects with advanced malignancies. Using the recommended
      phase II dose, the efficacy and tolerability of OPB-51602 administered prior to definitive
      chemoradiotherapy will be evaluated in locally advanced NPC patients. This study's
      overarching goal is the development of STAT3 inhibitors as a novel class of anti-cancer
      agents and the optimization of patient selection for STAT3 inhibitor therapy through parallel
      biomarker studies. This study hopes to establish a therapeutic window for OPB-51602 in solid
      tumours and will evaluate its potential as a targeted therapy of NPC, since this represents a
      critical unmet clinical need. The development of predictive and pharmacodynamic biomarkers in
      tandem with the clinical evaluation of OPB-51602 will be crucial to its therapeutic
      advancement and will enable an understanding of the genetic contexts of responsiveness and
      resistance to OPB-51602, which can in turn lead to the development of effective drug
      combinations to overcome resistance.The study hypothesizes that OPB-51602, a first-in-class
      STAT3 inhibitor, is efficacious in solid tumours with constitutively activated STAT3, such as
      NPC.
    

Detailed Description

      Part I This is a lead-in dose-finding, open-label, non-randomised study of OPB-51602 in
      patients with advanced refractory solid tumours who have biopsy-amenable lesions at study
      entry. Using a starting dose of 10mg per week, an accelerated dose titration escalation
      followed by a 3+3 design will be employed until MTD and recommended weekly dose are
      determined. Following this, an expansion cohort of 10 patients will be enrolled to establish
      safety of the recommended phase II dose. Additionally, it is also planned to explore the
      efficacy of the agent in an enrichment cohort of approximately 10 metastatic NPC patients.
      One treatment cycle is defined as a period of 28 days. Tumour biopsies will be performed at
      baseline while blood sampling for circulating biomarkers will be performed on days 1, 2, 3,
      8, 22 and upon completion of OPB-51602 dosing. Pharmacokinetic sampling will be done on Cycle
      1 Days 1, 8 and 22. Safety assessments will be performed weekly till week 8, bi-weekly till
      week 16, then monthly thereafter and response assessments will be performed every 8 weeks.
      The number of subjects estimated to participate in this study will depend on the number of
      cohorts enrolled.

      Part II This is a single-centre, open-label non-randomised phase II study evaluating
      OPB-51602 in stage III-IVB NPC conducted in the window period prior to definitive
      chemoradiotherapy. Eligible patients will receive OPB-51602 on a weekly basis (Day 1, 8, 15)
      at the recommended dose determined in part I for a total of 15 days prior to definitive
      chemoradiotherapy. Response assessment will be performed after OPB-51602 dosing on day 15
      using PET/CT scans and clinical tumour measurements, while other radiologic assessments will
      be performed on the completion of chemoradiotherapy. Safety assessments will be performed at
      weekly intervals until day 22 or until toxicities related to the study treatment have been
      resolved. Tumour biopsies will be performed at baseline and day 15 while circulating
      biomarker studies will be performed on days 1, 2, 3, 8, 15 and upon completion of
      chemoradiotherapy. There is no mandated rest period between the administration of study drug
      and definitive chemoradiotherapy. The decision to proceed with chemoradiotherapy is at the
      discretion of individual investigators, provided the subject has recovered or is recovering
      from all significant toxicities of the study drug. Chemoradiotherapy should be in accordance
      with the institutional standard and induction chemotherapy is not permitted. Proposed
      alternative treatment regimens must receive the approval of the Principal Investigator.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Recommended Phase II dose of OPB-51602


Condition

Nasopharyngeal Carcinoma

Intervention

OPB-51602

Study Arms / Comparison Groups

 Part I & Part II
Description:  Part I - This is a lead-in dose-finding, open-label, non-randomised arm of the study: Using a starting dose of 10mg per week, an accelerated dose titration escalation followed by a 3+3 design will be employed until MTD and recommended weekly dose are determined.
Part II - This is a single-centre, open-label non-randomised phase II study evaluating OPB-51602 in stage III-IVB NPC conducted in the window period prior to definitive chemoradiotherapy. Eligible patients will receive OPB-51602 on a weekly basis (Day 1, 8, 15) at the recommended dose determined in part I for a total of 15 days prior to definitive chemoradiotherapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

November 2013

Completion Date

May 2015

Primary Completion Date

May 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Part I only: Patients with pathologically confirmed, locally recurrent or metastatic
             solid tumours who have failed standard treatment options. In the enrichment cohort,
             NPC patients will be eligible as long as they have received prior platinum-based
             therapy, either in the curative or metastatic setting. At least one tumour lesion
             (primary or metastatic) that is suitable for baseline biopsy which is accessible
             either by free hand or image guided biopsy is required.

          -  Part II only: Patients with histologically confirmed WHO Type III NPC. Tumour stage
             III, IVA (T4 N0-2 M0) or IVB (Any T N3 M0) according to the American Joint Committee
             on Cancer (AJCC) 2010 criteria and planned for definitive chemoradiotherapy
             (radiotherapy at 70Gy/33# with concurrent IV cisplatin 40mg/m2/week for duration of
             radiotherapy) as per institutional standards. Patients who are planned for induction
             chemotherapy followed by concurrent chemoradiotherapy will not be included in the
             study. Patients receiving alternative chemoradiotherapy regimens may only be
             considered upon approval of the P.I.

          -  Age ≥ 21 years at the time of consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status < 1

          -  Life expectancy > 3 months

          -  Adequate organ function as defined by:

        Bone marrow function

          -  Haemoglobin ≥ 9g/dl

          -  Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

          -  Platelet count ≥ 75 x 109/L. Liver function

          -  Bilirubin  60mL/min for part II.

          -  Capable of swallowing OPB-51602 tablets

          -  Recovery from any previous drug- or procedure-related toxicity to National Cancer
             Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade
             0 or 1 (except alopecia), or to baseline preceding the prior treatment.

          -  Signed informed consent obtained before any study specific procedure. Subjects must be
             able to understand and be willing to sign the written informed consent.

        Exclusion Criteria:

          -  Part I only: Chemotherapy, radiotherapy, surgery, immunotherapy or other therapy
             within 4 weeks of starting investigational medicinal product (IMP).

          -  Part II only: Previous or concurrent anti-cancer chemotherapy, immunotherapy,
             radiotherapy or any other investigational therapy.

          -  Uncontrolled central nervous system metastasis (applicable to Part I)

          -  Any concomitant condition that could compromise the objectives of this study and/or
             the patient's compliance (eg. severe medical conditions such as uncontrolled
             infection, poorly controlled diabetes mellitus, hypercalcaemia, psychiatric
             disorders).

          -  Use of any of the prohibited medications and other substances listed in Appendix 2
             (CYP3A4 Inhibitors and Inducers) within 1 week prior to start of study drug
             administration

          -  Pregnancy or breastfeeding.

          -  Women of childbearing potential not employing adequate contraception. Women of
             childbearing potential must have a pregnancy test performed a maximum of 7 days before
             start of study medication, and a negative result must be documented before start of
             study medication. Women of childbearing potential and men, must agree to use adequate
             contraception (barrier method of birth control) upon signing the informed consent form
             until at least 3 months after the last study drug administration.

          -  Known or suspected allergy to the investigational agent or any agent given in
             association with this study.

          -  Previous or concurrent cancer which is distinct in primary site or histology from the
             cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
             cell carcinoma, superficial bladder tumours (Ta, Tis & T1) or any cancer curatively
             treated > 3 years prior to study entry.

          -  Interstitial lung disease with ongoing signs and symptoms at the time of screening.

          -  Patients with CTCAE Grade 2 or higher peripheral neuropathy.

          -  Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or
             pulmonary fibrosis

          -  History of significant cardiac disease: congestive cardiac failure > NYHA class II,
             ongoing unstable angina, new-onset angina or myocardial infarction within the past 3
             months
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrea Wong, MBBS, , 

Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT02058017

Organization ID

NP01/27/13

Secondary IDs

2013/00691

Responsible Party

Sponsor

Study Sponsor

National University Hospital, Singapore

Collaborators

 Otsuka Pharmaceutical Co., Ltd.

Study Sponsor

Andrea Wong, MBBS, Principal Investigator, National University Hospital, Singapore


Verification Date

June 2015