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Advanced Hepatocellular Carcinoma (HCC)Phase 2NCT01101906

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

A Phase 2 study testing OSI-906 in people with Advanced Hepatocellular Carcinoma (HCC), run by Astellas Pharma Inc at 41 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma (HCC)
What is being tested?
OSI-906
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
41 sitesin 10 countries
Study dates
10 Jan 2011to 28 Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

41 sites in 10 countries.

41 sites in 10 countries

France7 sites

  • Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie

    Bondy, 93143

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hopital de la Timone

    Marseille, 13385

  • Hopital l'Archet 2

    Nice, 6202

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital de Tenon

    Paris, 75020

  • Centre Rene Gauducheau

    Saint-Herblain, 44805

Other trials in France

United States6 sites

  • University of California - Los Angeles

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 52336

  • Tulane University Health Services Center

    New Orleans, Louisiana, 70112

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance University of Washington

    Seattle, Washington, 98109

Other trials in United States

South Korea6 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Kyungpook National University Hospital

    Daegu, 700-721

  • National Cancer Center

    Goyang-si, 410-769

  • Seoul National University Hospital

    Seoul, 110-774

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • China Medical University Hospital

    Taichung

  • Chang Gung Medical Foundation LinKou Branch

    Taoyuan, 333

Other trials in Taiwan

Germany4 sites

  • Universitatsklinikum Essen

    Essen, 45122

  • Universitätsklinikum Halle

    Halle, 06097

  • Universitatsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Magdeburg A.ö.R.

    Magdeburg, 39120

Other trials in Germany

Italy4 sites

  • Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I

    Milan, 20122

  • Ospedale Fatebenefratelli, Dipartimento Medicina Interna

    Naples, 80123

  • IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare

    Naples, 80131

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia

    Palermo, 90127

Other trials in Italy

Spain4 sites

  • Hospital Clinic Provincial

    Barcelona, 08036

  • Hospital Puerta de Hierro Majadahonda

    Madrid, 28220

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Coruna, 15706

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussells, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • Johns Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib

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.

Read the detailed description

Adult patients with advanced HCC previously treated with sorafenib will be randomized 2:1 to receive either single agent OSI-906 or placebo

Being tested
OSI-906, Placebo
Keywords
HCC, OSI-906, Hepatocellular Carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSI-906Drug

    OSI-906 administered orally

  • PlaceboDrug

    Matching placebo administered orally

Study groups in NCT01101906
Study groupRoleWhat they receive
Arm A: OSI-906Experimental150 mg BID
Receives: Drug: OSI-906
Arm B: PlaceboPlacebo comparatorPlacebo BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression (TTP)

    Time from randomization to radiological disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 20 months

Secondary outcomes (10)

  1. Overall Survival (OS)

    Date of randomization until the documented date of death

    Measured: 23 months

  2. Progression Free Survival (PFS)

    Time from randomization to radiological disease progression based on RECIST version 1.1 assessed by investigator or death due to any cause whichever occurs first

    Measured: 23 months

  3. Time to Progression (including clinical progression) (TTPc)

    Time from randomization to progression (either radiological disease progression based on RECIST version 1.1 or symptomatic clinical progression as assessed by investigator)

    Measured: 23 months

  4. Disease Control Rate (DCR)

    Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease based on RECIST version 1.1 criteria

    Measured: 23 months

  5. Overall Response Rate

    Proportion of patients with a best overall response of CR or PR based on RECIST version 1.1 criteria

    Measured: 23 months

  6. Time to progression in patients with hepatitis B virus (HBV) and/or hepatitis C virus (HVC)

    Measured: 23 months

  7. Progression Free Survival in patients with HBV and/or HCV

    Measured: 23 months

  8. Overall Survival in patients with HBV and/or HCV

    Measured: 23 months

  9. Overall Response Rate in patients with HBV and/or HCV

    Measured: 23 months

  10. Safety assessed via physical examination, vital signs, clinical laboratory tests, electrocardiograms (ECGs) and recording adverse events

    Measured: 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2010 (estimated)
  2. Study start10 Jan 2011
  3. Primary completion4 Nov 2011
  4. Study completion28 Dec 2011

Why it stopped: Company decided not to pursue the development of this drug in this patient population at this time

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101906
Sponsor's protocol ID
OSI-906-206
Other IDs
2010-018739-17
Status last verified
Nov 2024
First submitted
8 Apr 2010
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OSI-906 in people with Advanced Hepatocellular Carcinoma (HCC), run by Astellas Pharma Inc at 41 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in France, United States, South Korea, Taiwan, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company decided not to pursue the development of this drug in this patient population at this time). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (TTP) (time frame: 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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