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    Summary
    EudraCT Number:2019-002288-84
    Sponsor's Protocol Code Number:RR3
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002288-84
    A.3Full title of the trial
    Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing the delivery of an anti-cancer drug, gemcitabine, directly into the pancreas in patients with pancreatic cancer
    A.3.2Name or abbreviated title of the trial where available
    TIGeR-PaC
    A.4.1Sponsor's protocol code numberRR3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03257033
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRenovoRx, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRenovoRx
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRenovoRx, Inc.
    B.5.2Functional name of contact pointNicole G. Lama
    B.5.3 Address:
    B.5.3.1Street Address4546 El Camino Real, Suite 223
    B.5.3.2Town/ cityLos Altos, California
    B.5.3.3Post code 94022
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16502844433
    B.5.5Fax number+16503974433
    B.5.6E-mailnlama@renovorx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberDRU 2017-6209
    D.3 Description of the IMP
    D.3.1Product nameGemcitabine
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the Overall Survival, from time of randomization until death, between subjects receiving intra-arterial delivery of gemcitabine using the RenovoCath device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks in those subjects with stable disease following induction therapy with IV gemcitabine and nab-paclitaxel and radiation treatment for unresectable locally advanced pancreatic adenocarcinoma.
    E.2.2Secondary objectives of the trial
    To compare in subjects with locally advanced, unresectable pancreatic cancer treated with intra-arterial delivery of gemcitabine using the RenovoCath device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks:
    1. Primary Endpoint for treatment received and unresected analysis populations
    2. Progression free survival assessed according to RECIST 1.1 for all analysis populations
    3. Objective response rate and duration of response
    4. Health Related Quality of Life assessed with the EORTC, PCQL-10 and S-PGI questionnaires
    5. Degree of peripheral neuropathy
    6. Frequency of neutropenia requiring the use of filgrastim or other medications for white blood cell stimulation
    7. Tolerability and safety of the combination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent
    2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the first on study treatment).
    3. ECOG performance status 0-1
    4. Age ≥ 18 years
    5. Absolute neutrophil count ≥ 1,500/μL
    6. Platelet count ≥ 100,000/μL
    7. Hemoglobin ≥ 9.0 g/dL
    8. Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2for subjects with creatinine >1.5 mg/dL
    9. AST and ALT ≤ 3.0 X the upper normal limit of institution's normal range
    10. Prior to the initiation of the first on study treatment (Cycle 1/Day 1):
    a. Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range, or
    b. Total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range if biliary stent placed within 6 weeks of Cycle 1/Day 1 (see Section 6.1.4 for Dose Modifications)
    11. PT and PTT must be ≤ 1.5 X upper normal limit of institution's normal range
    12. INR ≤ 1.5
    13. Life expectancy > 12 weeks
    14. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day prior to administration of the first dose of chemotherapy. Women of childbearing potential should only use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation.
    15. Provide written informed consent
    16. Subjects willing to participate in the study for at least 8 months
    E.4Principal exclusion criteria
    1. Any prior treatment for pancreatic cancer; however, with prior written approval from the sponsor, an exception maybe granted for subjects who have had one prior treatment cycle with gemcitabine/nab-paclitaxel since this treatment is standard of care and part of the initial induction treatment on the protocol
    2. Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin
    3. Prior biliary bypass surgery
    4. Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment
    5. Subjects without baseline tumor imaging
    6. Anatomy suitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined by the sponsor, which precludes the following:
    a. Stenosis or occlusion in intended artery for treatment
    b. Tortuosity preventing the delivery of the guide sheath and or RenovoCath catheter to intended site
    c. Inability to exclude major side branches in the area of the intended RenovoCath occlusion
    d. No suitable artery with a diameter greater than 3mm in proximity of at least one side of the tumor
    Note: Suitable anatomy will be reviewed by RenovoRx Imaging Advisor after receipt of initial CT or MRI.
    7. Subjects with known HIV or active viral hepatitis
    8. Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    9. Signs or symptoms of infection within 2 weeks prior to the first study treatment
    10. Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible.
    11. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
    12. Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment
    13. Subjects with uncontrolled seizures
    14. Cardiovascular disease including unstable angina or life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction, congestive heart failure, coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction to ensure EF is not ≤ 40%, within last 3 months prior to the first study treatment.
    15. Life-threatening visceral disease or other severe concurrent disease
    16. Any of the following procedures prior to initiation of study treatment:
    a. Catheterization, endoscopy, stent or drain placement, within 48 hours, and laparoscopy without surgical intervention can be in less than 48 hours
    b. Minor surgery requiring light sedation (such as surgical laparoscopy) within 2 weeks
    c. Major surgery within 4 weeks
    17. Women who are breastfeeding
    18. Male or female subjects of reproductive potential who do not agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 6 months after last study treatment
    19. Subjects receiving any other investigational agents within 2 weeks prior to the first study treatment
    20. Any psychiatric illness or social situations that would limit compliance with study requirements
    21. Subjects unable or unwilling to have standard catherization procedure
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is defined as the time from randomization until death, in unresectable LAPC subjects with stable or responding disease after induction therapy with gemcitabine and nab-paclitaxel and radiation. The primary hypothesis is that stable unresectable LAPC subjects treated with intra-arterial gemcitabine over 16 weeks (Test Group) will survive longer than stable unresectable LAPC subjects who continue gemcitabine and nab-paclitaxel after induction gemcitabine and nab-paclitaxel (Control Group). The objective is to establish that the Test Group has longer OS than the Control Group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization until death
    E.5.2Secondary end point(s)
    Primary Endpoint Assessment for Treatment Received and Unresected Populations.
    Progression Free Survival for all Analysis Populations.
    Objective Response Rate and Duration of Response.
    Quality of Life
    Neuropathy Assessment
    Frequency of Neutropenia
    Subject Reported Adverse Events
    Tolerability and Safety of the Control vs Test Groups

    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Endpoint Assessment for Treatment Received and Unresected Populations- From randomization until death.
    Progression Free Survival for all Analysis Populations- From randomization until death.
    Objective Response Rate and Duration of Response- From randomization until death.
    Quality of Life- baseline and follow-up.
    Neuropathy Assessment- through progression of disease.
    Frequency of Neutropenia- through progression of disease.
    Subject Reported Adverse Events- through progression of disease.
    Tolerability and Safety of the Control vs Test Groups- through progression of disease.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    All randomized subjects should be followed for 3 years following their first randomized treatment dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 320
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-12
    P. End of Trial
    P.End of Trial StatusOngoing
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