Overview

This trial is active, not recruiting.

Conditions advanced or metastatic hepatocellular cancer, advanced or metastatic ovarian cancer, metastatic renal cell cancer, advanced or metastatic gastric carcinoma
Treatment tasquinimod
Phase phase 2
Sponsor Ipsen
Start date December 2012
End date December 2014
Trial size 201 participants
Trial identifier NCT01743469, 8-55-58102-004

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
tasquinimod
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.

Primary Outcomes

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)
time frame: 16 weeks
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
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

Secondary Outcomes

Measure
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
Response rate, defined by RECIST v1.1 (Cohort G)
time frame: Every 6 weeks until disease progression, up to 45 months
Clinical benefit (Cohorts H, R and O)
time frame: Every 8 weeks until disease progression, up to 45 months
Clinical benefit (Cohort G)
time frame: Every 6 weeks until disease progression, up to 45 months
Time to Progression Free Survival (PFS), (Cohorts H, R and O)
time frame: Every 8 weeks until disease progression, up to 45 months
Time to Progression Free Survival (PFS), (Cohort G)
time frame: Every 6 weeks until disease progression, up to 45 months
Time to Progression (TTP), (Cohorts H, R and O)
time frame: Every 8 weeks until disease progression, up to 45 months
Time to Progression (TTP), (Cohort G)
time frame: Every 6 weeks until disease progression, up to 45 months
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ipsen.