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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-019106-16
    Sponsor's Protocol Code Number:MK-1775009
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-019106-16
    A.3Full title of the trial
    Phase II and Pharmacological Study with Wee-1 Inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer
    that Show Early Relapse (< 3 months) or Progression during Standard First Line Treatment with Carboplatin – Paclitaxel Combination Therapy. With an additional safety and preliminary anti-tumor activity cohort of Wee-1 inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), cervical, and endometrial cancer that Show Early Relapse (<6 months) or Progression during Standard First Treatment with cisplatin or carboplatin containing therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study with AZD1775 combined with carboplatin in patients with ovarian cancer. An extra group with additional safety and anti-tumor activity in patients with Ovarian Cancer, lung cancer, cervical and endometrial cancer.
    A.3.2Name or abbreviated title of the trial where available
    M10MKO
    A.4.1Sponsor's protocol code numberMK-1775009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01164995
    A.5.4Other Identifiers
    Name:M10MKONumber:M10MKO
    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 SponsorNetherlands Cancer Institute (NKI)
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3120512 2446
    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 nameMK-1775
    D.3.2Product code MK-1775
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD1775
    D.3.9.1CAS number 855365-80-7
    D.3.9.2Current sponsor codeAZD1775
    D.3.9.3Other descriptive nameMK-1775
    D.3.9.4EV Substance CodeSUB30647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 300
    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
    p53 mutated epithelial ovarian cancer (after first line standard therapy), non-small cell lung cancer, small cell lung cancer, cervical and endometrial cancer
    E.1.1.1Medical condition in easily understood language
    cancer
    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 10014733
    E.1.2Term Endometrial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10055094
    E.1.2Term Cervix cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 safety and preliminary anti-tumor activity of AZD-1775 in combination with carboplatin in p53 mutated epithelial ovarian cancer in a 21 day schedule.

    Additional safety and preliminary anti-tumor activity cohort:
    To determine the safety and preliminary anti-tumor activity (RECIST 1.1) of AZD-1775 in combination with carboplatin in p53 mutated epithelial ovarian cancer, NSCLC, SCLC, cervical, and endometrial cancer, in a 21 day schedule.
    E.2.2Secondary objectives of the trial
    - To determine the pharmacokinetics of AZD1775 in plasma and of carboplatin in plasma and ultrafiltrates.
    - To determine pharmacodynamic changes induced by AZD1775 in combination with carboplatin in both surrogate tissues (skin).
    -To determine the time to progression.


    Secondary objectives safety and preliminary anti-tumor activity cohort:
    - To determine the time to progression.
    - To determine the pharmacodynamic changes induced by AZD1775 in combination with carboplatin in circulating tumor cells (CTC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. p53 mutated (determined by IHC and later by sequencing) epithelial ovarian cancer
    2. measurable disease on CT scan
    3. patients previously received standard 1st line platinum therapy (combined with paclitaxel) for epithelial ovarian cancer, and showed recurrence on or within 3 months of this treatment
    4. age > 18 years
    5. WHO performance status lower or equal to 1

    1. histological or cytological proof of advanced epithelial ovarian cancer, NSCLC, SCLC, cervical and endometrial cancer (with proven p53 mutation).
    2. previously treated with (standard) (1st) line platinum-based therapy (combined with paclitaxel in case of ovarian cancer ), and showed recurrence on or within 6 months after the end of this treatment.
    3. Patients are allowed to have received second line non-platinum containing therapy after recurrence on 1st line treatment. No more than 2 lines of pre-treatment with cytotoxic chemotherapy are allowed.
    4. Eligible patients will have p53 mutation determined by sequencing of exons 2-10.
    5. Able and willing to undergo a tumor biopsy (if p53 status is already known, tumor biopsy is still mandatory).
    E.4Principal exclusion criteria
    1. symptomatic cerebral or leptomeningeal metastases
    2. current participation or previous participation in a study with an investigational compound, or chemo- and/or radiotherapy within 28 days of receiving first dose of study medication
    3. patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy.

    Additional exclusion criteria for safety and activity cohort:
    1. More than 2 lines pre-treatment with cytotoxic chemotherapy are not allowed. Only the first line will be carboplatin or cisplatin containing.
    E.5 End points
    E.5.1Primary end point(s)
    Phase II proof-of-concept trial:
    - to determine the safety and preliminary anti-tumor activity of AZD-1775 in combination with carboplatin in p53 mutated epithelial ovarian cancer in 21 day schedule.

    Additional safety and preliminary anti-tumor activity cohort:
    -to determine the safety and preliminary anti-tumor activity (RECIST 1.1) of AZD-1775 in combination with carboplatin in p53 mutated epithelial ovarian cancer, NSCLC, SCLC, cervical and endometrial cancer in a 21 day schedule.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be assessed on a continuous basis;
    Preliminary anti-tumor activity will be assessed by CT-scan every 2 cycles (once per 6 weeks) and tumor markers (if applicable) every cycle (every 3 weeks).
    E.5.2Secondary end point(s)
    secondary objectives proof-of-concept trial:
    - To determine the pharmacokinetics (PK) of AZD1775 in plasma and of carboplatin in plasma and ultrafiltrates.
    - To determine pharmacodynamics (PD) changes induced by AZD1775 in combination with carboplatin in surrogate tissues (skin)
    - To determine the time to progression.

    Secondary objectives safety and preliminary anti-tumor activity cohort:
    - To determine the time to progression.
    - To determine the pharmacodynamic changes induced by AZD1775 in combination with carboplatin in circulating tumor cells (CTC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PK and PD: at day 1 of cycle 1
    -Time to progression: every 2 cycles (6 weeks)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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 Information not present in EudraCT
    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
    Currently, the end of the trial for this study is not fixed. Patients will continue treatment untill progression of disease or intolerable side-effects. After discontinuation, patients will continue in a long-term follow-up phase untill death or lost to follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state224
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 224
    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 Decision2010-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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