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    The EU Clinical Trials Register currently displays   38197   clinical trials with a EudraCT protocol, of which   6274   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002117-36
    Sponsor's Protocol Code Number:CT-CL02
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-26
    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 number2018-002117-36
    A.3Full title of the trial
    A Phase IIa Exploratory Study of CriPec® docetaxel Monotherapy in Subjects with Platinum Resistant Ovarian Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to explore the effect of docetaxel with a novel transport system (CriPec® docetaxel) in subjects with ovarian cancer, who became resistant to platinum based chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    CINOVA
    A.4.1Sponsor's protocol code numberCT-CL02
    A.5.4Other Identifiers
    Name:SMS-oncology study numberNumber:SMS-0423
    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 SponsorCristal Therapeutics
    B.1.3.4CountryNetherlands
    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 supportCristal Therapeutics
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointDaniela Leyton Puig
    B.5.3 Address:
    B.5.3.1Street AddressWalaardt Sacréstraat 401-403
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 BM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310204350580
    B.5.5Fax number+310204350589
    B.5.6E-mailregulatory@sms-oncology.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCriPec® docetaxel
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCRIPEC® BLOCK COPOLYMER
    D.3.9.3Other descriptive nameCRIPEC® BLOCK COPOLYMER
    D.3.9.4EV Substance CodeSUB178604
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number14 to 19
    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 No
    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
    Platinum Resistant Ovarian Cancer.
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer that is resistant to platinum based chemotherapy.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CriPec® docetaxel monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.
    E.2.2Secondary objectives of the trial
     To evaluate the safety and tolerability of CriPec® docetaxel according to NCI-CTCAE criteria (version 5.0)
     To evaluate the clinical activity of CriPec® docetaxel as measured by:
    o Progression free survival (PFS) at 6 months based on RECIST version 1.1 and combined assessment using Gynecological Cancer Intergroup (GCIG) definitions for CA-125
    o GCIG CA-125 response criteria
    o Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125
    o Time to progression (TTP)
    o Disease control rate (DCR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian or peritoneal cancer.
    3. Platinum-resistant recurrent epithelial ovarian cancer (defined as progression within 6 months after last platinum dose).
    4. Subjects who have received maximum of 2 prior treatment lines, of which one could have been taxane-based.
    5. Measurable disease according to RECIST version 1.1. Only CA-125 progression without any clinical or radiological progression is not allowed.
    6. Performance status (WHO scale/ECOG) ≤ 1 (Appendix 1).
    7. Estimated life expectancy of at least 5 months.
    8. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ Grade 2 (as defined by NCI- CTCAE version 5.0).
    9. ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 5.58 mmol/L (≥ 9.00 g/dL).
    10. Creatinine ≤ 1.75 x Upper Limit of Normal (ULN) and estimated creatinine clearance ≥ 30 mL/min according to Cockcroft-Gault formula; Serum albumin levels > 25g/L
    11. Serum bilirubin ≤ 1.5 x ULN except for subjects with Will Gilbert’s syndrome, alkaline phosphatase, ASAT and ALAT ≤ 2.5 x ULN, unless related to liver metastases, in which case ≤ 5 x ULN is allowed.
    12. Written informed consent according to local guidelines.
    E.4Principal exclusion criteria
    1. Subjects with platinum-refractory disease. Refractory disease is defined by subjects who progressed during the preceding treatment or within 4 weeks after last dose of platinum containing therapy.
    2. Less than four weeks since the last treatment with other anti-cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc.); less than eight weeks for cranial radiotherapy, and less than six weeks for nitrosoureas and mitomycin C prior to first study treatment.
    3. Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
    4. Active or symptomatic brain metastases. Subjects must be on a stable or decreasing dose of corticosteroids and/or have no requirement for anticonvulsants for five days prior to Cycle 1 day1 (C1D1).
    5. Current malignancies other than epithelial ovarian, fallopian or peritoneal cancer, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
    6. Major surgical procedure (including open biopsy, excluding central line IV and portacath) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
    7. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100mm Hg).
    8. Grade ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0).
    9. Known hypersensitivity to any of the study drugs or excipients or taxanes.
    10. Any skin toxicity in the medical history of the subject of Grade ≥ 2 associated with impaired skin integrity (skin toxicity defined as any form of rash, HFS, skin ulceration, toxic epidermal necrolysis, eczema) or any skin toxicity for which systemic treatment was needed.
    11. Clinically significant (i.e. active) cardiovascular disease defined as stroke, transient ischemic attack (TIA) or myocardial infarction within ≤ 6 months prior to first trial treatment.
    12. Subjects, who are pregnant or breastfeeding. Serum pregnancy test to be performed within 7 days prior to study treatment start in subjects of childbearing potential.
    13. Absence of highly effective method of contraception as of C1D1 in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile).
    14. Known hypersensitivity to dexamethasone or any other reason that would make the subject not eligible to receive dexamethasone.
    15. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, drug or alcohol abuse, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CriPec® docetaxel monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least twice throughout the trial, the Data Review Committee (DRC) will review tables, listings and figures, specifically capturing the data on safety and efficacy variables. The data for efficacy and safety will also be reviewed on a continuous basis.
    One review was held after subject 13 of Stage 1 had EOT response assessment. The DRC recommended continuation of the study to the second part.
    During the second part at least one DRC review is planned. The DRC will make a recommendation on the continuation of the enrollment in the second part of the trial, up to 14 additional subjects for a total of 27 subjects.
    E.5.2Secondary end point(s)
    • To evaluate the safety and tolerability of CriPec® docetaxel according to NCI-CTCAE criteria (version 5.0)
    • To evaluate the clinical activity of CriPec® docetaxel as measured by:
    o Progression free survival (PFS) at 6 months based on RECIST version 1.1 and combined assessment using Gynecological Cancer Intergroup (GCIG) definitions for CA-125
    o GCIG CA-125 response criteria
    o Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125
    o Time to progression (TTP)
    o Disease control rate (DCR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At least twice throughout the trial, the Data Review Committee (DRC) will review tables, listings and figures, specifically capturing the data on safety and efficacy variables. The data for efficacy and safety will also be reviewed on a continuous basis.
    One review was held after subject 13 of Stage 1 had EOT response assessment. The DRC recommended continuation of the study to the second part.
    During the second part at least one DRC review is planned. The DRC will make a recommendation on the continuation of the enrollment in the second part of the trial, up to 14 additional subjects for a total of 27 subjects.
    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 No
    E.6.4Safety Yes
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    The end of trial is defined as the time point when all subjects in the trial have either discontinued trial treatment or received more than six cycles of treatment, whichever occurs sooner.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 27
    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)
    Any subject eligible for further treatment cycles at time of end of trial may continue to receive further treatment cycles with CriPec® docetaxel until discontinuation or withdrawal.
    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 Decision2018-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-06
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