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Advanced or Metastatic Hepatocellular CancerPhase 2NCT01743469

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

A Phase 2 study testing Tasquinimod in people with Advanced or Metastatic Hepatocellular Cancer and Advanced or Metastatic Ovarian Cancer, run by Ipsen at 24 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tasquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
24 sitesin 5 countries
Study dates
Dec 2012to Apr 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent and to comply with the study protocol and procedures.
  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy greater than 3 months in the Investigator's opinion.
  • Disease progression during or after previous cancer treatment.
  • Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria (v1.1).
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  • 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.
  • Recovery to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
  • At least 4 weeks since any major surgery or open biopsy and 7 days since a core biopsy before first study treatment.
  • 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.
  • 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).
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L.
  • Platelets ≥50 x 10^9/L.
  • Haemoglobin ≥90 g/L.
  • Adequate coagulation tests: international normalised ratio (INR) ≤1.5 x ULN.
  • Able to swallow capsules.
  • For women of childbearing potential, a negative pregnancy test must have been documented prior to first administration of study treatment.
  • 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.
  • 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.
  • Histologically confirmed and documented hepatocellular carcinoma (excluding fibrolamellar carcinoma).
  • Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy.
  • 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.
  • 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.
  • Child-Pugh A Class only.
  • Previously treated with sorafenib. Patients may have experienced radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy.
  • 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).
  • 18. Histologically confirmed and documented ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
  • 19. Progression within 6 months of a platinum containing chemotherapy regimen (i.e. platinum resistant).
  • 20. Progression after up to three lines of chemotherapy.
  • 21. Maximum one line treatment with antiangiogenic therapy.
  • 18. Metastatic renal cell carcinoma.
  • 19. Histologically or cytologically confirmed and documented renal cell carcinoma with a clear cell component.
  • 20. Previous treatment with at least one vascular endothelial growth factor inhibitor.
  • 21. Disease progression within 6 months prior to first study treatment.
  • 22. Patient had at most two prior targeted therapies for unresectable advanced or metastatic disease.
  • 18. Histologically or cytologically confirmed and documented adenocarcinoma of the stomach or gastroesophageal junction.
  • 19. Unresectable advanced or initially metastatic or recurrent after curative resection.
  • 20. Progression after one prior regimen of chemotherapy including fluoropyrimidine and platinum (with or without trastuzumab, if human epidermal growth factor receptor 2 positive [HER2+]).
  • 21. Maximum one line treatment with antiangiogenic therapy.

Who cannot join

  • 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).
  • Known central nervous system metastasis that was symptomatic and/or required treatment.
  • Malabsorption (other than in patients with gastric carcinoma and partial or complete gastrectomy) or intestinal obstruction.
  • History of pancreatitis.
  • Essential medications that are known potent inhibitors or inducers of CYP3A4.
  • 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.
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  • 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.
  • Evidence of bleeding diathesis or known coagulopathy.
  • History of venous thromboembolic disease within 3 months prior to first administration of study treatment.
  • The patient had current, severe and uncontrolled medical condition such as infection, diabetes mellitus or other systemic disease.
  • 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.
  • Had known positive serology for human immunodeficiency virus.
  • Investigational drug within 28 days or within five times the elimination half-life (whichever was longest) prior to first dose of study treatment.
  • Known allergy to treatment medication or its excipients.
  • Breastfeeding.
  • 16. Fibrolamellar carcinoma.
  • 16. Non-epithelial cancer and borderline tumours (e.g. tumours of low malignant potential).
  • 16. Other histologic type than adenocarcinoma.

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

France8 sites

  • Hospital Beaujon, 100 Blvd du Général Leclerc

    Clichy, 92110

  • Centre Oscar Lambret, 3 rue Frédéric Combemale

    Lille, 59020

  • Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec

    Lyon, 69008

  • Hospital Saint-Antoine, 184 rue du Faubourg St Antoine

    Paris, 75012

  • Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc

    Paris, 75015

  • Centre Eugene Marquis, Avenue bataille Flandres Dunkerque

    Rennes, 35042

  • Centre René Gauducheau, Boulevard Jacques Monod

    Saint-Herblain, 44805

  • Institute Gustave-Roussy, 114 rue Edouard Vaillant

    Villejuif, 94805

Other trials in France

United Kingdom6 sites

  • Beatson West of Scotland Cancer Centre, 1053 Great Western Road

    Glasgow, G12 0YN

  • Leicester General Hospital, Gwndolen Road

    Leicester, LE5 4PW

  • The Royal Marsden Hospital, Downs Rd, Sutton

    London, SM2 5PT

  • The Christie Hospital, Wilmslow Road, Withington

    Manchester, M20 4BX

  • Freeman Hospital, Freeman Road, High Heaton

    Newcastle upon Tyne, NE7 7DN

  • Southampton General Hospital, Tremona Road, Shirley

    Southampton, SO16 6YD

Other trials in United Kingdom

Canada4 sites

  • Juravinski Cancer Centre, 699 Concession St

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Center, 790 Commissoners Road East

    London, Ontario, N6A 4L6

  • Sunnybrook, 2075 Bayview Avenue, Suite T2049

    Toronto, Ontario, M4N 3M5

  • Princess Margaret, 610 University Avenue

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Belgium3 sites

  • Antwerp University Hospital, Wilrijkstraat 10

    Edegem, 2650

  • Ghent University Hospital, 1K12 IE, De Pintelaan 185

    Ghent, 9000

  • Leuven cancer institute (LKI), Herestraat

    Leuven, 3000

Other trials in Belgium

Spain3 sites

  • Hospital del mar, Paseo Maritimo 25-29

    Barcelona, 08003

  • Hospital Gregorio Marañon, Dr. Esquerdo, 44-46

    Madrid, 28007

  • MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,

    Madrid, 28034

Other trials in Spain

About this study

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

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.
Being tested
Tasquinimod
Keywords
Advanced, Metastatic, Hepatocellular cancer, Ovarian cancer, Renal cell cancer, Gastric carcinoma
Medical subject headings
Liver Neoplasms, Ovarian Neoplasms, Carcinoma, Renal Cell, Stomach Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TasquinimodDrug

    Also called ABR-215050

    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.

  • TasquinimodDrug

    Also called ABR-215050

    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.

  • TasquinimodDrug

    Also called ABR-215050

    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.

  • TasquinimodDrug

    Also called ABR-215050

    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.

Study groups in NCT01743469
Study groupRoleWhat they receive
Hepatocellular Carcinoma CohortExperimental1 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.
Receives: Drug: Tasquinimod
Ovarian Carcinoma CohortExperimental1 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.
Receives: Drug: Tasquinimod
Renal Cell Carcinoma CohortExperimental1 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.
Receives: Drug: Tasquinimod
Gastric Carcinoma CohortExperimental1 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.
Receives: Drug: Tasquinimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  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'.

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

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 16 weeks, Last Patient First Treatment + 16 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01743469
Sponsor's protocol ID
8-55-58102-004
Other IDs
2012-002326-75
Status last verified
Jan 2019
First submitted
29 Nov 2012
Last updated
8 Jan 2019
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tasquinimod in people with Advanced or Metastatic Hepatocellular Cancer and Advanced or Metastatic Ovarian Cancer, run by Ipsen at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, United Kingdom, Canada, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01743469, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.

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