A Study With Tasquinimod Treating Patients in Four Independent Cohorts of Hepatocellular, Ovarian, Renal Cell and Gastric Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01743469
First received: November 29, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This is an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma (Cohort H), ovarian carcinoma (Cohort O), renal cell carcinoma (Cohort R) and gastric carcinoma (Cohort G) who have progressed after standard therapies.


Condition Intervention Phase
Advanced or Metastatic Hepatocellular Cancer
Advanced or Metastatic Ovarian Cancer
Metastatic Renal Cell Cancer
Advanced or Metastatic Gastric Carcinoma
Drug: Tasquinimod
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Open Label, Early Stopping Design, Proof Of Concept Study With Tasquinimod In Treating Patients With Advanced Or Metastatic Hepatocellular, Ovarian, Renal Cell And Gastric Carcinomas.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Progression free survival [PFS] rate, defined as the proportion of patients who have neither progressed nor died as measured by RECIST v1.1 (both Cohorts H and R) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Progression free survival [PFS] rate, defined as the proportion of patients who have neither progressed nor died as measured by RECIST v1.1 (Cohort G) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Progression free survival [PFS] rate, defined as the proportion of patients who have neither progressed nor died as measured by RECIST v1.1 (Cohort O) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, defined by RECIST v1.1 (Cohorts H, R and O) and Choi criteria (Cohort H) [ Time Frame: Every 8 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
  • Response rate, defined by RECIST v1.1 (Cohort G) [ Time Frame: Every 6 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
  • Clinical benefit (Cohorts H, R and O) [ Time Frame: Every 8 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    Clinical benefit defined as complete response + partial response + stable disease lasting at least 12 weeks

  • Clinical benefit (Cohort G) [ Time Frame: Every 6 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    Clinical benefit defined as complete response + partial response + stable disease lasting at least 12 weeks

  • Time to Progression Free Survival (PFS), (Cohorts H, R and O) [ Time Frame: Every 8 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    PFS defined as the time from first study treatment to progression or death due to any cause

  • Time to Progression Free Survival (PFS), (Cohort G) [ Time Frame: Every 6 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    PFS defined as the time from first study treatment to progression or death due to any cause

  • Time to Progression (TTP), (Cohorts H, R and O) [ Time Frame: Every 8 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    TTP defined as the time from first study treatment to disease progression

  • Time to Progression (TTP), (Cohort G) [ Time Frame: Every 6 weeks until disease progression, up to 45 months ] [ Designated as safety issue: No ]
    TTP defined as the time from first study treatment to disease progression

  • Overall survival (OS), defined as the time from first study treatment to death due to any cause. [ Time Frame: Time from first study treatment to death, up to 45 months ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: December 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tasquinimod
1 capsule (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, unacceptable toxicity or willingness to stop.
Drug: Tasquinimod
Other Name: 1 capsule:initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5mg/day or decreasing to 0.25mg after at least 2 weeks.

Detailed Description:

The clinical activity of tasquinimod will be evaluated independently in each individual cohort of patients of the four different tumour types, namely Cohort H, Cohort O, Cohort R and Cohort G respectively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic or advanced hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage C or B not amenable to locoregional therapy or refractory to locoregional therapy, Child-Pugh A, previously treated by sorafenib
  • Histologically confirmed metastatic or advanced ovarian epithelial, fallopian tube or primary peritoneal cavity cancer, progression within 6 months of a platinum containing chemotherapy regimen
  • Histologically confirmed metastatic renal cell cancer, previously treated with at least one vascular endothelial growth factor (VEGF) inhibitor, at most two prior targeted therapies
  • Histologically confirmed metastatic or advanced gastric cancer after one line of chemotherapy containing platinum and fluoropyrimidine

Exclusion Criteria:

  • Other primary malignancy within the past 3 years (except for fully resected non melanoma skin cancer, localised prostate cancer with normal prostate specific antigen level, or cervical cancer in situ)
  • Malabsorption (other than in Cohort G patients and partial or complete gastrectomy) or intestinal obstruction
  • History of pancreatitis
  • History of myocardial infarction, unstable angina, congestive heart failure New York Heart Association class III/IV, cerebrovascular accident, transient ischaemic attack, limb claudication at rest in the previous 6 months, or ongoing symptomatic dysrhythmias, or uncontrolled atrial, or ventricular arrhythmias, or uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743469

Locations
Belgium
Antwerp University Hospital, Wilrijkstraat 10
Edegem, Belgium, 2650
Ghent University Hospital, 1K12 IE, De Pintelaan 185
Gent, Belgium, 9000
Leuven cancer institute (LKI), Herestraat
Leuven, Belgium, 3000
Canada, Ontario
Juravinski Cancer Centre, 699 Concession St
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Center, 790 Commissoners Road East
London, Ontario, Canada, N6A 4L6
Princess Margaret, 610 University Avenue
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook, 2075 Bayview Avenue, Suite T2049
Toronto, Ontario, Canada, M4N 3M5
France
Hospital Beaujon, 100 Blvd du Général Leclerc
Clichy, France, 92110
Centre Oscar Lambret, 3 rue Frédéric Combemale
Lille cedex, France, 59020
Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec
Lyon, France, 69008
Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc
Paris, France, 75015
Hospital Saint-Antoine, 184 rue du Faubourg St Antoine
Paris, France, 75012
Centre Eugene Marquis, Avenue bataille Flandres Dunkerque
Rennes cedex, France, 35042
Centre René Gauducheau, Boulevard Jacques Monod
Saint Herblain, France, 44805
Institute Gustave-Roussy, 114 rue Edouard Vaillant
Villejuif, France, 94805
Spain
Hospital del mar, Paseo Maritimo 25-29
Barcelona, Spain, 08003
MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,
Madrid, Spain, 28034
Hospital Gregorio Marañon, Dr. Esquerdo, 44-46
Madrid, Spain, 28007
United Kingdom
Beatson West of Scotland Cancer Centre, 1053 Great Western Road
Glasgow, United Kingdom, G12 0YN
Leicester General Hospital, Gwndolen Road
Leicester, United Kingdom, LE5 4PW
The Royal Marsden Hospital, Downs Rd, Sutton
London, United Kingdom, SM2 5PT
The Christie Hospital, Wilmslow Road, Withington
Manchester, United Kingdom, M20 4BX
Freeman Hospital, Freeman Road, High Heaton
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Southampton General Hospital, Tremona Road, Shirley
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Nathalie GERMANN, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01743469     History of Changes
Other Study ID Numbers: 8-55-58102-004
Study First Received: November 29, 2012
Last Updated: July 28, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Liver Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 28, 2014