CClinicalTrials.gg
Sign In
CompletedNCT01743469Updated Jan 8, 2019Results posted

A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers

A Phase 2 interventional study of Tasquinimod and Tasquinimod in Advanced or Metastatic Hepatocellular Cancer, Advanced or Metastatic Ovarian Cancer and Metastatic Renal Cell Cancer, sponsored by Ipsen. Completed at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by Ipsen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
201
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies.

Read the detailed description

This was an early stopping design, Phase II, open label, exploratory proof of concept study to evaluate the activity of tasquinimod in four independent cohorts of patients with different tumour types (patients with hepatocellular, ovarian, renal cell or gastric carcinoma, each with progressive disease after standard therapies). Patients initially received 0.5 mg/day tasquinimod dose, increasing to 1 mg/day after at least 2 weeks, unless there were any individual patient safety and tolerability concerns. The treatment period continued until patient disease progression, lost to follow-up, withdrawal or death. During the treatment period, initial study visits were at Week 2, 4 and 8 (± 2 days) for the hepatocellular carcinoma, the ovarian carcinoma and the renal cell carcinoma cohorts and at Week 2, 4 and 6 (± 2 days) for the gastric carcinoma cohort, to allow careful safety monitoring and to facilitate the identification of the individually tolerated dose. After Week 8, when most patients should have reached their tolerable dose, visit frequency was decreased as follows: at Week 16 and 24 (± 2 days) for the hepatocellular carcinoma, the ovarian carcinoma and the renal cell carcinoma cohorts; and at Week 12, 18 and 24 (± 2 days) for the gastric carcinoma cohort. Thereafter visits were once every 8 weeks (± 2 days) for all cohorts. An end of study treatment/withdrawal (EoST/WD) Visit was to be performed at least 14 days after the last dose of study treatment, and/or before treatment with any alternative antitumour therapy was started. Patients who stopped study treatment before disease progression were to be followed up with tumour imaging every 8 weeks until disease progression. Each patient was subsequently followed up for survival (by visit or telephone call) every 3 months after the EoST/WD Visit until death, lost to follow-up, or withdrawal of consent, or until all surviving patients had been followed-up for at least 9 months after their last administration of study treatment.

The clinical activity of tasquinimod was evaluated independently in each cohort of patients of the four different tumour types. Data were presented as of the following study cut-off dates:

  • Hepatocellular carcinoma cohort: 03 December 2014 (efficacy data); 11 April 2016 (safety data).
  • Ovarian carcinoma cohort: 27 November 2013 (efficacy data); 05 October 2015 (safety data).
  • Renal cell carcinoma cohort: 04 December 2013.
  • Gastric carcinoma cohort: 27 September 2013.
02

Conditions studied

  • Advanced or Metastatic Hepatocellular Cancer
  • Advanced or Metastatic Ovarian Cancer
  • Metastatic Renal Cell Cancer
  • Advanced or Metastatic Gastric Carcinoma

Keywords

  • Advanced
  • Metastatic
  • Hepatocellular cancer
  • Ovarian cancer
  • Renal cell cancer
  • Gastric carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 201 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria - All Patients:

  1. Able and willing to provide written informed consent and to comply with the study protocol and procedures.
  2. Age ≥18 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  4. Life expectancy greater than 3 months in the Investigator's opinion.
  5. Disease progression during or after previous cancer treatment.
  6. Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria (v1.1).

  7. The following time must have elapsed between previous therapy for cancer and first administration of tasquinimod:

    • At least 2 weeks since previous systemic targeted therapy with small molecule inhibitors, which included any tyrosine-kinase inhibitor.
    • At least 4 weeks since the last dose of systemic anti-cancer therapy other than targeted therapy, which included cytotoxic agents, monoclonal antibody therapy, immunotherapy and prior radiotherapy.
    • At least 1 week since prior hormonal therapy.
    • At least 3 months since prior interferon therapy.
  8. Recovery to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
  9. At least 4 weeks since any major surgery or open biopsy and 7 days since a core biopsy before first study treatment.

  10. Adequate renal function:

    • Creatinine ≤1.5 times upper limit of normal (ULN) or calculated creatinine clearance (CrCl) using the Cockcroft Gault formula ≥60 mL/min, or CrCl ≥60 mL/min.

  11. Adequate hepatic function:

    • Serum bilirubin ≤1.5 mg/dL (≤25 μmol/L) for ovarian carcinoma, renal cell carcinoma and gastric carcinoma, serum bilirubin ≤3 mg/dL (≤50 μmol/L) for hepatocellular carcinoma cohorts.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver lesions were present i.e. liver metastasis or primary tumour of the liver for hepatocellular carcinoma cohort).

  12. Adequate bone marrow function:

    • Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L.
    • Platelets ≥50 x 10\^9/L.
    • Haemoglobin ≥90 g/L.
  13. Adequate coagulation tests: international normalised ratio (INR) ≤1.5 x ULN.
  14. Able to swallow capsules.
  15. For women of childbearing potential, a negative pregnancy test must have been documented prior to first administration of study treatment.
  16. For women who were not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use adequate methods of contraception (e.g. hormonal implants, combined oral contraceptives, vasectomised partner), during the treatment period and for at least 3 months after the last dose of study treatment.

  17. For men: agreement to use a barrier method of contraception during the treatment period and for at least 3 months after the last dose of study treatment.

    Inclusion Criteria - Hepatocellular Carcinoma Cohort:

  18. Histologically confirmed and documented hepatocellular carcinoma (excluding fibrolamellar carcinoma).
  19. Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy.
  20. Liver mass measuring at least 2 cm with characteristic vascularisation seen on either triphasic computed tomography (CT) scan or Magnetic Resonance Imaging (MRI) with gadolinium.
  21. At least one measurable or evaluable lesion that was viable (i.e. vascularised), and had not been previously treated with locoregional therapy. A lesion that had been previously treated qualified as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy.
  22. Child-Pugh A Class only.
  23. Previously treated with sorafenib. Patients may have experienced radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy.
  24. The patient had received sorafenib as the most recent systemic therapeutic intervention (any hepatic locoregional therapy that had been administered prior to sorafenib was allowed, but not following sorafenib; radiation to metastatic sites [e.g. bone] following sorafenib therapy was permitted).

Inclusion Criteria - Ovarian Carcinoma Cohort:

  1. Histologically confirmed and documented ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
  1. Progression within 6 months of a platinum containing chemotherapy regimen (i.e. platinum resistant).
  1. Progression after up to three lines of chemotherapy.
  1. Maximum one line treatment with antiangiogenic therapy.

Inclusion Criteria - Renal Cell Carcinoma Cohort:

  1. Metastatic renal cell carcinoma.
  1. Histologically or cytologically confirmed and documented renal cell carcinoma with a clear cell component.
  1. Previous treatment with at least one vascular endothelial growth factor inhibitor.
  1. Disease progression within 6 months prior to first study treatment.
  1. Patient had at most two prior targeted therapies for unresectable advanced or metastatic disease.

Inclusion Criteria - Gastric Carcinoma Cohort:

  1. Histologically or cytologically confirmed and documented adenocarcinoma of the stomach or gastroesophageal junction.
  1. Unresectable advanced or initially metastatic or recurrent after curative resection.
  1. Progression after one prior regimen of chemotherapy including fluoropyrimidine and platinum (with or without trastuzumab, if human epidermal growth factor receptor 2 positive [HER2+]).
  1. Maximum one line treatment with antiangiogenic therapy.

Exclusion Criteria - All Patients:

  1. 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).
  2. Known central nervous system metastasis that was symptomatic and/or required treatment.
  3. Malabsorption (other than in patients with gastric carcinoma and partial or complete gastrectomy) or intestinal obstruction.
  4. History of pancreatitis.
  5. Essential medications that are known potent inhibitors or inducers of CYP3A4.
  6. Ongoing treatment with CYP1A2 (including warfarin) or CYP3A4 metabolised drug substance with narrow therapeutic range at the start of study. Treatment with low molecular weight heparin (LMWH) was permitted.
  7. 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.
  8. Evidence of bleeding diathesis or known coagulopathy.
  9. History of venous thromboembolic disease within 3 months prior to first administration of study treatment.
  10. The patient had current, severe and uncontrolled medical condition such as infection, diabetes mellitus or other systemic disease.
  11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would have compromised patient safety or interfered with the evaluation of the safety of the drug.
  12. Had known positive serology for human immunodeficiency virus.
  13. Investigational drug within 28 days or within five times the elimination half-life (whichever was longest) prior to first dose of study treatment.
  14. Known allergy to treatment medication or its excipients.
  15. Breastfeeding.

Exclusion Criteria - Hepatocellular Carcinoma Cohort:

  1. Fibrolamellar carcinoma.

Exclusion Criteria - Ovarian Carcinoma Cohort:

  1. Non-epithelial cancer and borderline tumours (e.g. tumours of low malignant potential).

Exclusion Criteria - Gastric Carcinoma Cohort:

  1. Other histologic type than adenocarcinoma.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • Experimental
    Hepatocellular Carcinoma Cohort

    1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

    Drug: Tasquinimod

  • Experimental
    Ovarian Carcinoma Cohort

    1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

    Drug: Tasquinimod

  • Experimental
    Renal Cell Carcinoma Cohort

    1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

    Drug: Tasquinimod

  • Experimental
    Gastric Carcinoma Cohort

    1 capsule of tasquinimod (0.25 mg or 0.5 mg or 1 mg) taken orally each day until disease progression, lost to follow-up, withdrawal or death.

    Drug: Tasquinimod

Interventions

  • DrugTasquinimod

    1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

    Also known as: ABR-215050

  • DrugTasquinimod

    1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

    Also known as: ABR-215050

  • DrugTasquinimod

    1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

    Also known as: ABR-215050

  • DrugTasquinimod

    1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.

    Also known as: ABR-215050

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).

    Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions. 'Progressed or Died' when time between start of study drug \&first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause. 'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication \&last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'.

    Time frame: Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).

Secondary outcomes

  1. PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).

    PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria. Response was measured using the following criteria: CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit \[HU\]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions.

    Time frame: Week 16.

  2. Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).

    Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

    Time frame: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).

  3. Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).

    Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

    Time frame: Every 8 weeks until disease progression, up to 36 months.

  4. Clinical Benefit (All Cohorts).

    Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.

    Time frame: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).

  5. PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).

    PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.

    Time frame: Every 8 weeks until disease progression, up to 36 months.

  6. PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).

    PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.

    Time frame: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).

  7. Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).

    TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.

    Time frame: Every 8 weeks until disease progression, up to 36 months.

  8. TTP by RECIST v1.1 (All Cohorts).

    TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.

    Time frame: Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).

  9. Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).

    OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits). OS was estimated using Kaplan-Meier analysis.

    Time frame: Time from first study treatment to death, up to 36 months.

  10. Further Cancer-related Treatment During Follow-up Period (All Cohorts).

    Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts). A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name.

    Time frame: 16 weeks, Last Patient First Treatment + 16 weeks.

07

Results

Posted May 7, 2018

Participant flow

Patients were recruited from 24 investigational sites in Belgium, Canada, the United Kingdom, Spain and France. The first patient was enrolled in December 2012 and the study was completed in April 2016.

Active Treatment Phase
Participant flow — Active Treatment Phase
MilestoneHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Started53553821
Completed0000
Not completed53553821
Withdrew: Adverse event10581
Withdrew: Disease progression40473020
Withdrew: Withdrawal by subject2300
Withdrew: Missing1000
Follow-up Period - Post-Treatment
Participant flow — Follow-up Period - Post-Treatment
MilestoneHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Started51533721
Completed65145
Not completed45482316
Withdrew: Withdrawal by subject1010
Withdrew: Death43472216
Withdrew: Lost to follow-up1100

Outcome measures

PrimaryProgression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).

Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions. 'Progressed or Died' when time between start of study drug \&first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause. 'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication \&last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'.

Time frame:
Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).
Reported as:
Number · percentage of participants
Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).
percentage of participantsHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).26.9 (15.57 to 41.02)7.3 (2.02 to 17.59)13.2 (4.41 to 28.09)9.5 (1.17 to 30.38)
Statistical analysis
  • Hepatocellular Carcinoma Cohort · Exact binomial test · p = 0.142 (One-sided alpha of 0.1.)
  • Ovarian Carcinoma Cohort · Exact binomial test · p = 1.000 (One-sided alpha of 0.1.)
  • Renal Cell Carcinoma Cohort · Exact binomial test · p = 0.800 (One-sided alpha of 0.1)
  • Gastric Carcinoma Cohort · Exact binomial test · p = 0.630 (One-sided alpha of 0.1)
SecondaryPFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).

PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria. Response was measured using the following criteria: CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit \[HU\]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions.

Time frame:
Week 16.
Reported as:
Number · percentage of participants
PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).
percentage of participantsHepatocellular Carcinoma Cohort
PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).20.8 (10.84 to 34.11)
Statistical analysis
  • Hepatocellular Carcinoma Cohort · Exact binomial test · p = 0.500 (One-sided alpha of 0.1.)
SecondaryBest Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).

Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Time frame:
Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Reported as:
Number · percentage of participants
Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).
percentage of participantsHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Best overall response: PR (centrally assessed)1.9 (0.05 to 10.07)1.8 (0.05 to 9.72)0 (NA to NA)0 (NA to NA)
Best overall response: SD (centrally assessed)54.7 (40.45 to 68.44)49.1 (35.35 to 62.93)47.4 (30.98 to 64.18)23.8 (8.22 to 47.17)
Best overall response: PD (centrally assessed)34.0 (21.52 to 48.27)41.8 (28.65 to 55.89)44.7 (28.62 to 61.70)66.7 (43.03 to 85.41)
Best overall response: NE (centrally assessed)9.4 (3.13 to 20.66)7.3 (2.02 to 17.59)7.9 (1.66 to 21.38)9.5 (1.17 to 30.38)
Response rate (CR or PR) (centrally assessed)1.9 (0.05 to 10.07)1.8 (0.05 to 9.72)0 (NA to NA)0 (NA to NA)
Best overall response: PR (locally assessed)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)
Best overall response: SD (locally assessed)52.8 (38.64 to 66.70)32.7 (20.68 to 46.71)39.5 (24.04 to 56.61)14.3 (3.05 to 36.34)
Best overall response: PD (locally assessed)43.4 (29.84 to 57.72)61.8 (47.73 to 74.59)57.9 (40.82 to 73.69)81.0 (58.09 to 94.55)
Best overall response: NE (locally assessed)3.8 (0.46 to 12.98)5.5 (1.14 to 15.12)2.6 (0.07 to 13.81)4.8 (0.12 to 23.82)
Response rate (CR or PR) (locally assessed)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)
SecondaryBest Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).

Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Time frame:
Every 8 weeks until disease progression, up to 36 months.
Reported as:
Number · percentage of participants
Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
percentage of participantsHepatocellular Carcinoma Cohort
Best overall response: PR20.8 (10.84 to 34.11)
Best overall response: SD32.1 (19.92 to 46.32)
Best overall response: PD34.0 (21.52 to 48.27)
Best overall response: NE13.2 (5.48 to 25.34)
Response rate (CR or PR)20.8 (10.84 to 34.11)
SecondaryClinical Benefit (All Cohorts).

Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.

Time frame:
Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Reported as:
Number · percentage of participants
Clinical Benefit (All Cohorts).
percentage of participantsHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Clinical benefit (centrally assessed)26.4 (15.26 to 40.33)20.0 (10.43 to 32.97)15.8 (6.02 to 31.25)0.0 (NA to NA)
Clinical benefit (locally assessed)32.1 (19.92 to 46.32)16.4 (7.77 to 28.80)15.8 (6.02 to 31.25)0.0 (NA to NA)
SecondaryPFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).

PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.

Time frame:
Every 8 weeks until disease progression, up to 36 months.
Reported as:
Median · Weeks
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).
WeeksHepatocellular Carcinoma Cohort
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).15.71 (8.00 to 16.43)
SecondaryPFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).

PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.

Time frame:
Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Reported as:
Median · Weeks
PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).
WeeksHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
PFS (centrally assessed)15.86 (8.00 to 23.14)8.00 (7.71 to 17.43)14.86 (7.86 to 16.71)6.00 (5.29 to 7.29)
PFS (locally assessed)15.71 (8.00 to 16.43)7.57 (7.00 to 7.86)7.86 (7.29 to 14.71)5.79 (5.14 to 6.86)
SecondaryTime to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).

TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.

Time frame:
Every 8 weeks until disease progression, up to 36 months.
Reported as:
Median · Weeks
Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).
WeeksHepatocellular Carcinoma Cohort
Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).15.86 (8.43 to 16.43)
SecondaryTTP by RECIST v1.1 (All Cohorts).

TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.

Time frame:
Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).
Reported as:
Median · Weeks
TTP by RECIST v1.1 (All Cohorts).
WeeksHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
TTP (centrally assessed)15.86 (8.43 to 24.00)8.00 (7.71 to 17.43)14.86 (7.86 to 16.00)6.00 (5.29 to 7.29)
TTP (locally assessed)15.71 (8.00 to 16.43)7.57 (7.00 to 7.86)7.86 (7.29 to 14.71)5.79 (5.14 to 6.86)
SecondaryOverall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).

OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits). OS was estimated using Kaplan-Meier analysis.

Time frame:
Time from first study treatment to death, up to 36 months.
Reported as:
Median · Weeks
Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).
WeeksHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).29.29 (25.00 to 38.71)NA (30.71 to NA)32.71 (26.43 to 40.86)21.57 (13.86 to 33.29)
SecondaryFurther Cancer-related Treatment During Follow-up Period (All Cohorts).

Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts). A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name.

Time frame:
16 weeks, Last Patient First Treatment + 16 weeks.
Reported as:
Count of participants · Participants
Further Cancer-related Treatment During Follow-up Period (All Cohorts).
ParticipantsHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
Further Cancer-related Treatment During Follow-up Period (All Cohorts).1635188

Adverse events

Collected over Treatment emergent adverse events (TEAEs) were collected during the active phase of the study from treatment start date until predefined timepoint T2, over approximately 1 year.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hepatocellular Carcinoma Cohort38/53 (71.7%)14/53 (26.4%)53/53 (100%)
Ovarian Carcinoma Cohort22/55 (40%)19/55 (34.5%)55/55 (100%)
Renal Cell Carcinoma Cohort22/38 (57.9%)11/38 (28.9%)38/38 (100%)
Gastric Carcinoma Cohort16/21 (76.2%)7/21 (33.3%)21/21 (100%)
Most frequent serious events
Showing 10 of 65
Most frequent serious events
EventHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
NauseaGastrointestinal disorders0/530/550/382/21
VomitingGastrointestinal disorders1/531/550/382/21
Pleural effusionRespiratory, thoracic and mediastinal disorders0/534/550/380/21
AstheniaGeneral disorders2/530/550/381/21
Oedema peripheralGeneral disorders0/531/550/381/21
CellulitisInfections and infestations0/530/550/381/21
DehydrationMetabolism and nutrition disorders0/530/551/381/21
Flank painMusculoskeletal and connective tissue disorders0/530/550/381/21
Renal failure acuteRenal and urinary disorders0/531/550/381/21
Bile duct obstructionHepatobiliary disorders0/530/550/381/21
Most frequent other events
Showing 10 of 79
Most frequent other events
EventHepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma Cohort
FatigueGeneral disorders31/5331/557/3815/21
Decreased appetiteMetabolism and nutrition disorders21/5320/5511/3815/21
NauseaGastrointestinal disorders21/5324/5512/3813/21
VomitingGastrointestinal disorders18/5316/559/3813/21
ConstipationGastrointestinal disorders15/5312/5513/3811/21
Back painMusculoskeletal and connective tissue disorders9/5314/555/3811/21
Abdominal painGastrointestinal disorders15/5319/558/389/21
Oedema peripheralGeneral disorders16/5317/554/382/21
AstheniaGeneral disorders7/535/5511/380/21
InsomniaPsychiatric disorders9/539/556/386/21

Baseline characteristics

Intent-to-treat (ITT) population: All treated patients i.e. all patients who had received at least one dose of tasquinimod.

Age, Categorical
Age, Categorical(Participants)Hepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma CohortTotal
<=18 years00000
Between 18 and 65 years1934251189
>=65 years3421131078
Sex: Female, Male
Sex: Female, Male(Participants)Hepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma CohortTotal
Female85510477
Male450281790
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Hepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma CohortTotal
Hispanic or Latino10102
Not Hispanic or Latino33533319138
Unknown or Not Reported1924227
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Hepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma CohortTotal
American Indian or Alaska Native00000
Asian32027
Native Hawaiian or Other Pacific Islander00000
Black or African American22004
White29493517130
More than one race00000
Unknown or Not Reported1923226
Region of Enrollment
Region of Enrollment(Participants)Hepatocellular Carcinoma CohortOvarian Carcinoma CohortRenal Cell Carcinoma CohortGastric Carcinoma CohortTotal
Canada3229438
Belgium3100215
United Kingdom311141341
France43912266
Spain13307
08

Study locations

24 sites
  • Antwerp University Hospital, Wilrijkstraat 10
    Edegem, 2650, Belgium
  • Ghent University Hospital, 1K12 IE, De Pintelaan 185
    Gent, 9000, Belgium
  • Leuven cancer institute (LKI), Herestraat
    Leuven, 3000, Belgium
  • Juravinski Cancer Centre, 699 Concession St
    Hamilton, Ontario L8V 5C2, Canada
  • London Health Sciences Center, 790 Commissoners Road East
    London, Ontario N6A 4L6, Canada
  • Sunnybrook, 2075 Bayview Avenue, Suite T2049
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret, 610 University Avenue
    Toronto, Ontario M5G 2M9, Canada
  • Hospital Beaujon, 100 Blvd du Général Leclerc
    Clichy, 92110, France
  • Centre Oscar Lambret, 3 rue Frédéric Combemale
    Lille cedex, 59020, France
  • Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec
    Lyon, 69008, France
  • Hospital Saint-Antoine, 184 rue du Faubourg St Antoine
    Paris, 75012, France
  • Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc
    Paris, 75015, France
  • Centre Eugene Marquis, Avenue bataille Flandres Dunkerque
    Rennes cedex, 35042, France
  • Centre René Gauducheau, Boulevard Jacques Monod
    Saint Herblain, 44805, France
  • Institute Gustave-Roussy, 114 rue Edouard Vaillant
    Villejuif, 94805, France
  • Hospital del mar, Paseo Maritimo 25-29
    Barcelona, 08003, Spain
  • Hospital Gregorio Marañon, Dr. Esquerdo, 44-46
    Madrid, 28007, Spain
  • MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,
    Madrid, 28034, Spain
  • Beatson West of Scotland Cancer Centre, 1053 Great Western Road
    Glasgow, G12 0YN, United Kingdom
  • Leicester General Hospital, Gwndolen Road
    Leicester, LE5 4PW, United Kingdom
  • The Royal Marsden Hospital, Downs Rd, Sutton
    London, SM2 5PT, United Kingdom
  • The Christie Hospital, Wilmslow Road, Withington
    Manchester, M20 4BX, United Kingdom
  • Freeman Hospital, Freeman Road, High Heaton
    Newcastle-upon-Tyne, NE7 7DN, United Kingdom
  • Southampton General Hospital, Tremona Road, Shirley
    Southampton, SO16 6YD, United Kingdom
09

References and documents

Publications

  • Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget JC, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Target Oncol. 2017 Oct;12(5):655-661. doi: 10.1007/s11523-017-0525-2. PubMed 28798986 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01743469
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Dec 6, 2012
Start date
Dec 2012
Primary completion
Dec 2014
Completion
Apr 2016
Results posted
May 7, 2018
Last update
Jan 8, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Ipsen

Start the discussion