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    Summary
    EudraCT Number:2016-000193-38
    Sponsor's Protocol Code Number:ENGOT-EN1/FANDANGO
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-05-10
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-000193-38
    A.3Full title of the trial
    ENGOT-EN1/FANDANGO: A randomized phase II trial of first-line combination chemotherapy with nintedanib / placebo for patients with advanced or recurrent endometrial cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENGOT-EN1/FANDANGO: A randomized double-blind phase II trial of combination chemotherapy with nintedanib or placebo for patients with endometrial cancer.
    A.3.2Name or abbreviated title of the trial where available
    ENGOT-EN1/FANDANGO
    A.4.1Sponsor's protocol code numberENGOT-EN1/FANDANGO
    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 SponsorNordic Society of Gynaecological Oncology (NSGO)
    B.1.3.4CountryDenmark
    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 supportNSGO
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNSGO
    B.5.2Functional name of contact pointStudy Project Management
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Oncology 9431 Rigshospitalet, Copenhagen University Hospital Blegdamsvej 9,
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535453311
    B.5.5Fax number+4535454391
    B.5.6E-mailmansoor.raza.mirza@regionh.dk
    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.2.1.1.1Trade name Vargatef
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNintedanib 100 mg capsules
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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.2.1.1.1Trade name Vargatef
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNintedanib 150 mg capsules
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histological confirmed endometrial cancer. (FIGO 2009) stage 3C2 or stage 4 or relapsed after adjuvant therapy for stage 1-3 disease.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014741
    E.1.2Term Endometrial cancer stage IV
    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 21.0
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10014734
    E.1.2Term Endometrial 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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014735
    E.1.2Term Endometrial cancer NOS
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10014736
    E.1.2Term Endometrial cancer recurrent
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10014740
    E.1.2Term Endometrial cancer stage III
    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
    Primary objective:
    To compare Progression free survival (PFS). Progression Free Survival (PFS) is de-fined as the time from randomization until disease progression or death by any cause. The progression events are defined by RECIST 1.1 criteria
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • Compare Progression free survival (PFS) in the sub-populations.
    • Progression-free survival after consecutive treatment (PFS2).
    • Compare Disease Specific Survival (DSS). Disease Specific Survival (DSS) is defined as the time from start of treatment until date of death from en-dometrial cancer.
    • TSST (Time to Second Subsequent Therapy)
    • TFST (Time to First Subsequent Therapy)
    • Overall Survival (OS). A patient’s overall survival is defined as the time from start of treatment until date of death from any cause.
    • Response Rate (RR).
    • Disease Control Rate (DCR = Complete Response, Partial Response or Stable Disease for at least 12 weeks).
    • Patient Related Outcomes (e.g. QoL).
    • Toxicity in the two treatment arms
    • Compliance and Exposure in the two treatment arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5.1. Inclusion criteria
    A patient will be eligible for inclusion only if all of the following criteria are fulfilled:

    1. Histological confirmed endometrial cancer (FIGO 2009).

    a) Stage 3C 2.
    b) Stage 4A & 4B.
    c) First relapse. Relapsed patients may (or may not) have received adjuvant chemo-therapy. In case a patient has received adjuvant chemotherapy, the treatment-free interval should be >6 months.

    Prior therapy
    2. Patients may have undergone primary surgery.
    3. Patients may have received adjuvant chemotherapy for stage 1–3.
    4. Patients may have received vaginal brachytherapy.
    5. Patients may have received external beam radiotherapy. Patients who are to be
    enrolled for stage 3C2 diseases are allowed to receive external beam radiotherapy
    prior to trial entry.
    6. Patients may have received hormonal treatment.

    Disease status
    7. Patients must have measurable disease or non-measurable disease on CT scan
    according to RECIST 1.1 outside irradiated field. For stage 3C2 disease patients
    without measureable or non-measureable disease are accepted.

    Other inclusion criteria:
    8. Patients must give informed consent.
    9. ECOG performance status of 0-1.
    10. Patients must have an adequate organ function:
    o Hepatic function: total bilirubin within normal limits; ALT and AST ≤ 1.5 x ULN in pts without liver metastasis. For Pts with liver metastasis: total bilirubin within normal limits, ALT or AST ≤ 2.5 ULN.
    o Coagulation parameters: International normalised ratio (INR) < 2, prothrom-bin time (PT) and partial thromboplastin time (PTT) < 50% of deviation of in-stitutional ULN.
    o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109L; hae-moglobin ≥ 9.0 g/dL.
    o Proteinuria < grade 2.
    o Creatinine < 1,5 ULN or GFR > 45 ml/min (calculated using Cockroft & Gault equation, Jellife equation or measured by EDTA clearance).
    11. Life expectancy of at least 12 weeks.
    12. Patients must be fit to receive combination chemotherapy.
    13. Patient’s age > 18 years.
    14. Patients with preserved reproductive capacity must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment.
    E.4Principal exclusion criteria
    5.2. Exclusion criteria
    A patient will not be eligible for inclusion if any of the following criteria are fulfilled:

    Target Disease Exceptions:
    1. Sarcomas, small cell carcinoma with neuroendocrine differentiation or non-epithelial cancers.

    Prohibited Treatments and/or Therapies
    2. Concurrent cancer therapy.
    3. Previous Chemotherapy for stage 4 disease or for relapsed disease.
    4. Previous treatment with anti-angiogenic/anti VEGF therapy including Nintedanib.
    5. Concurrent treatment with an investigational agent or participation in another clinical trial.
    6. Treatment within 28 days prior to randomisation with any investigational drug, ra-diotherapy, immunotherapy, chemotherapy, hormonal therapy or biological therapy. Pal-liative radiotherapy may be permitted for symptomatic control of pain from bone metas-tases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease.
    7. Major injuries or surgery within the past 21 days prior to start of study treatment with
    incomplete wound healing and/or planned surgery during the on-treatment study period.

    Other exclusion criteria
    8. Relapse within six months after adjuvant chemotherapy (treatment-free interval < 182 days).
    9. Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least three years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carci-noma of the skin.
    10. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
    11. Evidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the Investigator’s judgement, make the patient in-appropriate for this study.
    12. Known contraindications to VEGF directed therapy.
    13. Known uncontrolled hypersensitivity to the investigational drugs.
    14. History of major thromboembolic event defined as:
    • Uncontrolled pulmonary embolism (PE), defined as pulmonary embolism (PE) within 6 months prior to enrolment and/or recurrent pulmonary embolism (history of at least 2 events).
    • Deep venous thrombosis (DVT).
    • Other related conditions, though patients with stable therapeutic anticoagula-tion for more than three months prior randomization are eligible for this study.
    15. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 3 months.
    16. History of clinically significant haemorrhage in the past 3 months.
    17. Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
    18. Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy.
    19. Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexame-thasone therapy will be allowed if administered as stable dose for at least one month before randomisation).
    20. Leptomeningeal disease.
    21. Significant cardiovascular diseases (i.e. uncontrolled hypertension (hypertension not controlled by medical therapy), unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, clinically relevant cardiac arrhythmia, pericardial effusion) (See Appendix 11).
    22. Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwill-ing to use a medically acceptable method of contraception for the duration of the trial and for 3 months afterwards (see chapther 8.7).
    23. Radiographic evidence of cavitating or necrotic tumours with invasion of adjacent major blood vessels.
    24. Known active or chronic hepatitis C and/or B infection and/or HIV.
    25. Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy.
    26. Known hypersensitivity to the trial drugs, or to their excipients.
    27. Contra-indication to the use of Carboplatin-Paclitaxel combination.
    28. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
    29. Unable or unwilling to swallow tablets/capsules.
    30. Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or admin-istrative order).
    31. Subjects that are depending on the sponsor/CRO or investigational site as well as on the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end-point
    To compare Progression Free Survival (PFS) of patients treated with chemotherapy plus nintedanib against chemotherapy plus placebo. Progression Free Survival (PFS) is defined as the time from randomization until disease progression or death by any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis will be perform once 124 events are registered
    No interim analysis is planned
    E.5.2Secondary end point(s)
    Secondary end-points
    • Compare Progression free survival (PFS) in the sub-populations as de-scribed under stratification factors.
    • Progression-free survival after consecutive treatment (PFS2). PFS2 is de-fined along the same timelines as PFS but accounts for the time from ran-domization to progression or death by any cause on any subsequent line of anticancer therapy.
    • Compare Disease Specific Survival (DSS). Disease Specific Survival (DSS) is defined as the time from start of treatment until date of death from en-dometrial cancer.
    • TSST (Time to Second Subsequent Therapy)
    • TFST (Time to First Subsequent Therapy)
    • Overall Survival (OS). A patient’s overall survival is defined as the time from start of treatment until date of death from any cause.
    • Response Rate (RR).
    • Disease Control Rate (DCR = Complete Response, Partial Response or Stable Disease for at least 12 weeks).
    • Patient Related Outcomes (e.g. QoL).
    • Toxicity in the two treatment arms
    • Compliance and Exposure in the two treatment arms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Only after the primary endpoint is mature
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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
    LVLS
    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 months0
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 148
    F.4.2.2In the whole clinical trial 148
    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)
    No post trial treatment planned. Patient will be treated at the discretion of treating physician as per standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ENGOT
    G.4.3.4Network Country European Union
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-03-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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