Know Cancer

or
forgot password

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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced or Metastatic Hepatocellular Cancer, Advanced or Metastatic Ovarian Cancer, Metastatic Renal Cell Cancer, Advanced or Metastatic Gastric Carcinoma

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Nathalie GERMANN, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

8-55-58102-004

NCT ID:

NCT01743469

Start Date:

December 2012

Completion Date:

February 2016

Related Keywords:

  • Advanced or Metastatic Hepatocellular Cancer
  • Advanced or Metastatic Ovarian Cancer
  • Metastatic Renal Cell Cancer
  • Advanced or Metastatic Gastric Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Liver Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms

Name

Location