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Terminated/Withdrawn
Astellas Study ID
OSI-906-206

A Randomized, Placebo-controlled, Double-blind Phase 2 Study with OSI-906 in Patients with Advanced HCC

Astellas Study ID
OSI-906-206
Clinicaltrials.gov ID
NCT01101906
EUCTIS ID
N/A
EudraCT ID
2010-018739-17
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.

Additional Study Details

Phase
2
Product
N/A
Product
OSI-906
Placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
23
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Download Document(s)
Plain Language Summary
Available Language(s): English
Download Document(s)

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Would you like more information about clinical trial sites that are recruiting participants for A Randomized, Placebo-controlled, Double-blind Phase 2 Study with OSI-906 in Patients with Advanced HCC? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

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    Terminated
    IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare
    Napoli, Italy, 80131
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    Terminated
    Hôpital Henri Mondor
    Creteil cedex, France, 94010
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    Terminated
    Oregon Health & Science University
    Portland, Oregon, United States, 97239
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    Terminated
    Ospedale Fatebenefratelli, Dipartimento Medicina Interna
    Napoli, Italy, 80123
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    Terminated
    Johns Hopkins Singapore International Medical Centre
    Singapore, Singapore, 308433
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    Terminated
    Pusan National University Hospital
    Busan, Republic of Korea, 602-739
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    Terminated
    Hospital Puerta de Hierro Majadahonda
    Madrid, Spain, 28220
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    Terminated
    Hôpital Saint-Antoine
    Paris cedex 12, France, 75012
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    Terminated
    Universitatsklinikum des Saarlandes
    Homburg, Germany, 66421
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    Terminated
    Changhua Christian Hospital
    Changhua, Taiwan, Province of China, 500
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    Terminated
    Singapore General Hospital
    Singapore, Singapore, 169608
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    Terminated
    Universitätsklinikum Magdeburg A.ö.R.
    Magdeburg, Germany, 39120
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    Terminated
    Seoul National University Hospital
    Seoul, Republic of Korea, 110-774
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    Terminated
    Severance Hospital
    Seoul, Republic of Korea, 120-752
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    Terminated
    Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I
    Milano, Italy, 20122
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    Terminated
    Hopital Jean Verdier – Dervice d’Hepato-Gastroenterologie
    Bondy Cedex, France, 93143
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    Terminated
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Taiwan, Province of China, 807
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    Terminated
    Cliniques Universitaires Saint-Luc
    Brussells, Belgium, 1200
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    Terminated
    Medical College of Wisconsin
    Milwaukee, Wisconsin, United States, 52336
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    Terminated
    Hospital Clinico Universitario de Santiago de Compostela
    Santiago de Compostela, Coruna, Spain, 15706
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    Terminated
    Tulane University Health Services Center
    New Orleans, Louisiana, United States, 70112
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    Terminated
    China Medical University Hospital
    Taichung, Taiwan, Province of China
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    Terminated
    Samsung Medical Center
    Seoul, Republic of Korea, 135-710
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    Terminated
    Hospital Clinic Provincial
    Barcelona, Spain, 08036
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    Withdrawn
    Sutter Pacific Medical Foundation
    San Francisco, California, United States, 94115
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    Terminated
    Hôpital de Tenon
    Paris cedex 12, France, 75020
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    Terminated
    Taichung Veterans General Hospital
    Taichung, Taiwan, Province of China, 40705
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    Terminated
    Clinica Universitaria de Navarra
    Pamplona, Spain, 31008
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    Terminated
    Kyungpook National University Hospital
    Daegu, Republic of Korea, 700-721
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    Terminated
    Hopital de la Timone
    Marseille Cedex 5, France, 13385
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    Terminated
    Hopital l'Archet 2
    Nice cedex 03, France, 6202
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    Terminated
    Universitatsklinikum Essen
    Essen, Germany, 45122
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    Terminated
    National Cancer Center
    Goyang-si, Republic of Korea, 410-769
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    Terminated
    Virginia Mason Medical Center
    Seattle, Washington, United States, 98101
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    Terminated
    Universitätsklinikum Halle
    Halle, Germany, 06097
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    Terminated
    Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia
    Palermo, Italy, 90127
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    Terminated
    University of California – Los Angeles
    Los Angeles, California, United States, 90095
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    Terminated
    Seattle Cancer Care Alliance University of Washington
    Seattle, Washington, United States, 98109
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    Terminated
    Chang Gung Medical Foundation LinKou Branch
    TaoYuan, Taiwan, Province of China, 333
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    Terminated
    Universitair Ziekenhuis Gent
    Gent, Belgium, 9000
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    Terminated
    Centre Rene Gauducheau
    Saint Herblain cedex, France, 44805
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    Terminated
    Queen Mary Hospital
    Hong Kong, Hong Kong
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    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Liver Cancer
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jan 2011 - Nov 2011
    Additional Study Details
    Inclusion Criteria
    • Histologically confirmed diagnosis of advanced HCC. Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients is acceptable. For patients without cirrhosis histological confirmation is mandatory
    • Patients must have received prior systemic treatment for advanced HCC with sorafenib and had confirmed disease progression or had discontinued sorafenib due to a drug related toxicity
    • Patient has received their last dose of sorafenib at least 14 days prior to randomization
    • Patient has recovered from sorafenib or investigational agent related toxicity to ≤ grade 2
    • Measurable disease according to RECIST (version 1.1)
    • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 1
    • Child-Pugh Status A or B(7)
    • Barcelona Clinic Liver Cancer (BCLC) stage B/C
    • Previous local therapy (eg, surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) is permitted if ≥ 21 days before randomization
    • Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization
    • Following laboratory parameters (determined by laboratory):
      • Platelets ≥ 60 x 10^9/L
      • Hemoglobin ≥ 8.5 g/dL
      • Absolute neutraphil count (ANC) ≥ 1.5 x 10^9/L
      • Potassium within normal limits (supplementation may be used)
      • Partial thrombopastin time (PTT) ≤ 2.3 x Upper Limit of Normal (ULN)
      • Magnesium within normal limits (supplementation may be used)
      • Calcium within normal limits (supplementation may be used)
    • Adequate organ function (for a HCC population):
      • Liver function test (LFT) ≤ 5 x ULN
      • Albumin ≥ 2.8 g/dL
      • Total bilirubin ≤ 2.8 mg/dL
      • Creatinine ≤ 1.5 x ULN
      • International normalized ratio (INR) ≤ 2.3
    • Estimated life expectancy ≥ 12 weeks based on an investigator assessment of recent changes in laboratory values, performance status, and other clinical criteria
    • Patients, both males and females, with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to randomization
    • Patients must provide written informed consent to participate in the study
    • Prior radiation therapy is permitted provided patients have recovered from the acute, toxic effects of radiotherapy prior to randomization. A minimum of 21 days must have elapsed between the end of radiotherapy and randomization; and
    • Prior surgery is permitted provided that the surgery was done ≤ 28 days prior to randomization and adequate wound healing has occurred prior to randomization
    MaximizeExclusion Criteria
    • Child-Pugh B (8 - 9) or C
    • Patients who are candidates for potentially curative intervention (ie, surgical resection or transplantation)
    • Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
    • Prior insulin-like growth factor - 1 receptor (IGF-1R) therapy
    • Patients requiring interferon
    • Patients with uncontrolled symptomatic ascites
    • Prior investigational agent within 21 days prior to randomization
    • History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease, ulcerative colitis, etc)
    • History of organ allograft including liver transplant
    • Malignancy other than HCC within the past 3 years:
      • Exceptions: resected basal cell or squamous cell carcinoma of the skin, cured in situ cervical carcinoma, cured ductal carcinoma in situ of the breast, and/or cured superficial bladder cancer
    • History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
    • History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded
    • QTcF interval at screening ≥ 450 msec
    • Use of drugs that have a known risk of causing Torsades de Pointes (TdP) ('Torsades List' on www.azcert.org/medical-pros/drug-lists/by category.cfm)are prohibited within 14 days prior to randomization
    • Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
    • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability
    • Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to randomization) that would impair the ability of the patient to receive study drug
    • History of human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)-related illness or serious acute or chronic illness
    • History of any psychiatric or neurologic condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
    • Pregnant or breast-feeding females
    • Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to randomization; and/or
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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