A Study With Tasquinimod Treating Patients in Four Independent Cohorts of Hepatocellular, Ovarian, Renal Cell and Gastric Cancers
This study is currently recruiting participants.
Verified May 2013 by Ipsen
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01743469
First received: November 29, 2012
Last updated: May 29, 2013
Last verified: May 2013
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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 ]
| Estimated Enrollment: | 196 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743469
Contacts
| Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
Locations
| Belgium | |
| Antwerp University Hospital, Wilrijkstraat 10 | Recruiting |
| Edegem, Belgium, 2650 | |
| Ghent University Hospital, 1K12 IE, De Pintelaan 185 | Recruiting |
| Gent, Belgium, 9000 | |
| Leuven cancer institute (LKI), Herestraat | Recruiting |
| Leuven, Belgium, 3000 | |
| Canada, Ontario | |
| Juravinski Cancer Centre, 699 Concession St | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| The Credit Valley Hospital and Trillium Health Centre, 2200 Eglinton Ave. West | Withdrawn |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Canada | |
| Tom Baker Cancer Center, 2210-2nd Street SW | Withdrawn |
| Calgary, Canada, T2S 3C3 | |
| London Health Sciences Center, Ontario, 790 Commissoners Road East | Recruiting |
| London, Canada, N6A 4L6 | |
| CHUM, Hopital Notre Dame, 1560 Sherbrooke Street East | Withdrawn |
| Montreal, Canada, H2L 4M1 | |
| Hotel-Dieu de Quebec, 11 Cote du Palais | Withdrawn |
| Quebec, Canada, G1R 2J6 | |
| Sunnybrook, 2075 Bayview Avenue, Suite T2049 | Active, not recruiting |
| Toronto, Canada, M4N 3M5 | |
| Princess Margaret, 610 University Avenue, | Recruiting |
| Toronto, Canada, M5G 2M9 | |
| France | |
| Hospital Beaujon, 100 Blvd du Général Leclerc | Recruiting |
| Clichy, France, 92110 | |
| Centre Oscat Lambret, 3 rue Frédéric Combemale | Active, not recruiting |
| Lille cedex, France, 59020 | |
| Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec | Not yet recruiting |
| Lyon, France, 69008 | |
| Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc | Recruiting |
| Paris, France, 75015 | |
| Hospital Saint-Antoine, 184 rue du Faubourg St Antoine | Recruiting |
| Paris, France, 75012 | |
| Centre Eugene Marquis, Avenue bataille Flandres Dunkerque | Recruiting |
| Rennes cedex, France, 35042 | |
| Centre René Gauducheau, Boulevard Jacques Monod | Recruiting |
| Saint Herblain, France, 44805 | |
| Institute Gustave-Roussy, 114 rue Edouard Vaillant | Recruiting |
| Villejuif, France, 94805 | |
| Spain | |
| Hospital del mar, Paseo Maritimo 25-29 | Recruiting |
| Barcelona, Spain, 08003 | |
| MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100, | Recruiting |
| Madrid, Spain, 28034 | |
| Hospital Gregorio Marañon, Dr. Esquerdo, 44-46 | Active, not recruiting |
| Madrid, Spain, 28007 | |
| Hospital Univ La Paz, Paseo Castellana 261 | Withdrawn |
| Madrid, Spain, 28045 | |
| United Kingdom | |
| Beatson West of Scotland Cancer Centre, 1053 Great Western Road | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Leicester General Hospital, Gwndolen Road | Recruiting |
| Leicester, United Kingdom, LE5 4PW | |
| The Royal Marsden Hospital, Downs Rd, Sutton | Recruiting |
| London, United Kingdom, SM2 5PT | |
| The Christie Hospital, Wilmslow Road, Withington | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Freeman Hospital, Freeman Road, High Heaton | Recruiting |
| Newcastle-upon-Tyne, United Kingdom, NE7 7DN | |
| Southampton General Hospital, Tremona Road, Shirley | Recruiting |
| 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: | May 29, 2013 |
| 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 June 17, 2013