Trial · NCT01743469
A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers
NCT01743469, Phase 2, Completed, Ipsen; results first posted 2018-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers. Trials, record NCT01743469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01743469
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers
- NCT number
- NCT01743469
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 201 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Advanced or Metastatic Hepatocellular Cancer, Advanced or Metastatic Ovarian Cancer, Metastatic Renal Cell Cancer, Advanced or Metastatic Gastric Carcinoma
- Interventions
- Tasquinimod, Tasquinimod, Tasquinimod, Tasquinimod
- First posted
- 2012-12-06
- Last updated
- 2019-01-08
- Other registries' IDs
- eudract:2012-002326-75
- Results first posted
- 2018-05-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). | Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort). | 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'. |
| Secondary | PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort). | Week 16. | 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. |
| Secondary | Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | 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). | 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. |
| Secondary | Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | 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. |
| Secondary | Clinical Benefit (All Cohorts). | 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). | Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1. |
| Secondary | PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | 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. |
| Secondary | PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts). | 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). | 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. |
| Secondary | Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | 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. |
| Secondary | TTP by RECIST v1.1 (All Cohorts). | 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). | 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. |
| Secondary | Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts). | Time from first study treatment to death, up to 36 months. | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort). | ITT population: All treated patients i.e. all patients who had received at least one dose of tasquinimod. An additional patient was included in the hepatocellular carcinoma cohort, since the 52nd (last patient planned in the protocol) and 53rd were screened at the same time. This 53rd was not included in the primary analysis. | percentage of participants | NUMBER |
| SECONDARY | PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort). | Week 16. | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | 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). | ITT population: all treated patients i.e. all patients who had received at lease one dose of tasquinimod. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit (All Cohorts). | 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). | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | percentage of participants | NUMBER |
| SECONDARY | PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | Weeks | MEDIAN |
| SECONDARY | PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts). | 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). | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | Weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort). | Every 8 weeks until disease progression, up to 36 months. | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | Weeks | MEDIAN |
| SECONDARY | TTP by RECIST v1.1 (All Cohorts). | 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). | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | Weeks | MEDIAN |
| SECONDARY | Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts). | Time from first study treatment to death, up to 36 months. | ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod. | Weeks | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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). | Hepatocellular Carcinoma Cohort | 26.9 | 95% Confidence Interval 15.57 to 41.02 | 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). | Ovarian Carcinoma Cohort | 7.3 | 95% Confidence Interval 2.02 to 17.59 | 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). | Renal Cell Carcinoma Cohort | 13.2 | 95% Confidence Interval 4.41 to 28.09 | 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). | Gastric Carcinoma Cohort | 9.5 | 95% Confidence Interval 1.17 to 30.38 | percentage of participants | |
| PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort). | Hepatocellular Carcinoma Cohort | 20.8 | 95% Confidence Interval 10.84 to 34.11 | percentage of participants | |
| Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | Hepatocellular Carcinoma Cohort | Best overall response: PR (centrally assessed) | 1.9 | 95% Confidence Interval 0.05 to 10.07 | percentage of participants |
| Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | Ovarian Carcinoma Cohort | Best overall response: PR (centrally assessed) | 1.8 | 95% Confidence Interval 0.05 to 9.72 | percentage of participants |
| Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | Renal Cell Carcinoma Cohort | Best overall response: PR (centrally assessed) | 0 | 95% Confidence Interval NA to NA | percentage of participants |
| Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | Gastric Carcinoma Cohort | Best overall response: PR (centrally assessed) | 0 | 95% Confidence Interval NA to NA | percentage of participants |
| Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed). | Hepatocellular Carcinoma Cohort | Best overall response: SD (centrally assessed) | 54.7 | 95% Confidence Interval 40.45 to 68.44 | percentage of participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Active Treatment Phase | STARTED | Hepatocellular Carcinoma Cohort | 53 | |
| Active Treatment Phase | STARTED | Ovarian Carcinoma Cohort | 55 | |
| Active Treatment Phase | STARTED | Renal Cell Carcinoma Cohort | 38 | |
| Active Treatment Phase | STARTED | Gastric Carcinoma Cohort | 21 | |
| Active Treatment Phase | COMPLETED | Hepatocellular Carcinoma Cohort | 0 | |
| Active Treatment Phase | COMPLETED | Ovarian Carcinoma Cohort | 0 | |
| Active Treatment Phase | COMPLETED | Renal Cell Carcinoma Cohort | 0 | |
| Active Treatment Phase | COMPLETED | Gastric Carcinoma Cohort | 0 | |
| Active Treatment Phase | NOT COMPLETED | Hepatocellular Carcinoma Cohort | 53 | |
| Active Treatment Phase | NOT COMPLETED | Ovarian Carcinoma Cohort | 55 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events576
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Orthostatic hypotension | Vascular disorders | Hepatocellular Carcinoma Cohort | 0 | 53 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Ovarian Carcinoma Cohort | 0 | 55 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Renal Cell Carcinoma Cohort | 1 | 38 | 1 |
| other | Orthostatic hypotension | Vascular disorders | Gastric Carcinoma Cohort | 2 | 21 | 2 |
| other | Hypertension | Vascular disorders | Hepatocellular Carcinoma Cohort | 3 | 53 | 4 |
| other | Hypertension | Vascular disorders | Ovarian Carcinoma Cohort | 0 | 55 | 0 |
| other | Hypertension | Vascular disorders | Renal Cell Carcinoma Cohort | 0 | 38 | 0 |
| other | Hypertension | Vascular disorders | Gastric Carcinoma Cohort | 0 | 21 | 0 |
| other | Hypotension | Vascular disorders | Hepatocellular Carcinoma Cohort | 1 | 53 | 1 |
| other | Hypotension | Vascular disorders | Ovarian Carcinoma Cohort | 1 | 55 | 1 |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hepatocellular Carcinoma Cohort | 38 | 53 |
| Total, all-cause mortality | Ovarian Carcinoma Cohort | 22 | 55 |
| Total, all-cause mortality | Renal Cell Carcinoma Cohort | 22 | 38 |
| Total, all-cause mortality | Gastric Carcinoma Cohort | 16 | 21 |
| Total, other adverse events | Hepatocellular Carcinoma Cohort | 53 | 53 |
| Total, other adverse events | Ovarian Carcinoma Cohort | 55 | 55 |
| Total, other adverse events | Renal Cell Carcinoma Cohort | 38 | 38 |
| Total, other adverse events | Gastric Carcinoma Cohort | 21 | 21 |
| Total, serious adverse events | Hepatocellular Carcinoma Cohort | 14 | 53 |
| Total, serious adverse events | Ovarian Carcinoma Cohort | 19 | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28798986 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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