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    Summary
    EudraCT Number:2020-001574-29
    Sponsor's Protocol Code Number:D967VC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001574-29
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)
    Wieloośrodkowe, prowadzone metodą otwartej próby badanie fazy II, oceniające skuteczność i bezpieczeństwo stosowania trastuzumabu derukstekanu (T-DXd, DS 8201a) w leczeniu wybranych nowotworów wykazujących ekspresję receptora ludzkiego naskórkowego czynnika wzrostu typu 2 (HER2) (DESTINY-PanTumor02)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study of Trastuzumab Deruxtecan to assess its efficacy, safety and tolerability in Patients with Selected HER2 Expressing Tumors
    Badanie oceniające skuteczność, bezpieczeństwo i tolerancję leczenia T-DXd u pacjentów z wybranymi nowotworami wykazującymi ekspresję HER2.
    A.3.2Name or abbreviated title of the trial where available
    DESTINY-PanTumor02
    DESTINY-PanTumor02
    A.4.1Sponsor's protocol code numberD967VC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailinformation.center@astrazeneca.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 nameTrastuzumab Deruxtecan
    D.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNTrastuzumab deruxtecan
    D.3.9.1CAS number 1599440-13-7
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameAnti-HER2 antibody drug conjugate
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Treatment in locally advanced unresectable metastatic patients with HER2 overexpressed (IHC 3+ or IHC 2+) and HER2 low (1+) selected solid tumors not eligible for curative therapy.
    Leczenie pacjentów z miejscowo zaawansowanymi, nieoperacyjnymi nowotworami przerzutowymi z nadekspresją receptora ludzkiego naskórkowego czynnika wzrostu -HER2 (IHC 3+ lub IHC 2+) oraz z niską ekspresją (IHC 1+) HER2 w przypadku wybranych guzów litych niekwalifikującymi się do leczenia radykalnego
    E.1.1.1Medical condition in easily understood language
    Patients with Selected HER2 Expressing Tumors.
    Pacjenci z wybranymi guzami wykazującymi ekspresję HER2
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of T-DXd in patients with metastatic or unresectable tumors in selected HER2 expressing tumor types.
    Ocena skuteczności T DXd u pacjentów z przerzutowym lub nieoperacyjnym nowotworem w wybranych rodzajach nowotworów wykazujących ekspresję HER2
    E.2.2Secondary objectives of the trial
    - To further assess the efficacy of T-DXd in patients with metastatic or unresectable tumors in selected HER2-expressing tumor types
    - To assess the safety and tolerability of T-DXd
    - To assess the PK of T-DXd, total anti-HER2 antibody and MAAA-1181 in serum
    - To investigate the immunogenicity of T-DXd
    1. Dalsza ocena skuteczności T DXd u pacjentów z przerzutowym lub nieoperacyjnym nowotworem w wybranych rodzajach nowotworów wykazujących ekspresję HER2
    2. Ocena bezpieczeństwa i tolerancji T-DXd
    3. Ocena farmakokinetyki T DXd, całkowitego miana przeciwciał anty HER2 i MAAA-1181 w surowicy
    4. Ocena immunogenności T DXd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Locally advanced, unresectable, or metastatic disease based on most recent imaging.
    • The respective cohorts for patient inclusion are:
    - Cohort 1: Biliary tract cancer
    - Cohort 2: Bladder cancer
    - Cohort 3: Cervical cancer
    - Cohort 4: Endometrial cancer
    - Cohort 5: Epithelial ovarian cancer
    - Cohort 6: Pancreatic cancer
    - Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
    • Progressed following prior treatment or who have no satisfactory alternative treatment option.
    • Prior HER2 targeting therapy is permitted.
    • HER2 expression for eligibility may be based on local or central assessment.
    • Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
    • Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
    • Miejscowo zaawansowany, nieoperacyjny lub przerzutowy nowotwór na podstawie najnowszych wyników badań obrazowych.
    • Poszczególne kohorty, do których włączani są pacjenci, to:
    o Kohorta 1: rak dróg żółciowych
    o Kohorta 2: rak pęcherza moczowego
    o Kohorta 3 :rak szyjki macicy
    o Kohorta 4 :rak trzonu macicy
    o Kohorta 5: rak jajnika
    o Kohorta 6 :rak trzustki
    o Kohorta 7: nowotwory rzadkie: ta kohorta będzie obejmowała pacjentówz rozpoznaniem nowotworów wykazujących ekspresję HER2,
    z wyłączeniem nowotworów wskazanych powyżej, a także raka piersi, niedrobnokomórkowego raka płuca, raka żołądka i raka jelita grubego.
    • Pacjenci u których wystąpiła progresja choroby po wcześniejszym leczeniu, lub dla których nie istnieje zadowalająca alternatywna opcja leczenia.
    • Dozwolone jest wcześniejsze leczenie celowane nakierowane na HER2.
    • U pacjentów musi występować nadekspresja HER2 na podstawie oceny przeprowadzonej w laboratorium lokalnym lub centralnym.
    • Występowanie zmian mierzalnych, ocenianych przez badacza na podstawie kryteriów RECIST v1.1.
    • Wydolna czynność narządów w tym funkcji sercowo-naczyniowych, nerkowych o wątrobowych.
    E.4Principal exclusion criteria
    • Uncontrolled intercurrent illness
    • History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
    • Lung-specific intercurrent clinically significant severe illnesses
    • Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
    • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
    • Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
    • Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
    • Niekontrolowane choroby współistniejące
    • Występująca w wywiadzie (niezakaźna) choroba śródmiąższowa płuc (ILD)/niezakaźne zapalenie płuc, występująca obecnie ILD/niezakaźne zapalenie płuc lub sytuacja, w której nie można wykluczyć podejrzenia ILD/niezakaźnego zapalenia płuc w badaniu obrazowym podczas oceny przesiewowej
    • Współistniejące, klinicznie istotne ciężkie choroby dotyczące płuc
    • Niekontrolowane zakażenie wymagające dożylnego (i.v.) podania antybiotyków, leków przeciwwirusowych lub leków przeciwgrzybiczych
    • Wysięk opłucnowy, wodobrzusze lub wysięk osierdziowy, które wymagają drenażu, zastawki otrzewnowej lub leczenia wodobrzusza polegającego na reinfuzji płynu puchlinowego po usunięciu składników komórkowych (CART)
    • Rozpoznana somatyczna mutacja DNA w obrębie HER2 (ERBB2) bez ekspresji HER2 w komórkach guza
    • Pierwotne rozpoznanie gruczolakoraka piersi, gruczolakoraka okrężnicy lub odbytnicy, gruczolakoraka trzonu żołądka lub połączenia żołądkowo-przełykowego, lub niedrobnokomórkowego raka płuca
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR).
    Odsetek odpowiedzi obiektywnych (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    An average of approximately 12 months.
    średnio około 12 miesięcy
    E.5.2Secondary end point(s)
    1) Duration of response (DoR).
    2) Disease control rate (DCR).
    3) Progression free survival (PFS).
    4) Proportion of patients alive and progression-free at 6 months and 12 months.
    5) Overall survival (OS).
    6) Proportion of patients alive at 6 months and 12 months.
    7) Occurrence of adverse events (AEs) and serious adverse events (SAEs).
    8) Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181.
    9) The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.
    1. Czas trwania odpowiedzi (DOR)
    2. Odsetek kontroli choroby (DCR)
    3. Czas przeżycia bez progresji choroby (PFS)
    4. Odsetek pacjentów pozostających przy życiu i bez progresji choroby po 6 miesiącach i 12 miesiącach
    5. Przeżycie całkowite (OS)
    6. Odsetek pacjentów pozostających przy życiu po 6 miesiącach i 12 miesiącach
    7. Występowania zdarzeń niepożądanych (AEs) i ciężkich zdarzeń niepożądanych, (SAEs)
    8. Farmakokinetyka (PK) oceniana na podstawie stężenia T DXd, całkowitego miana przeciwciał anty HER2 i MAAA-1181 w surowicy
    9. Immunogenności T DXd oceniana na podstawie obecności przeciwciał przeciwlekowych (ADAs) przeciwko T DXd
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) An average of approximately 18 months.
    2) An average of approximately 18 months.
    3) An average of approximately 18 months.
    4) Up to 12 months.
    5) An average of approximately 30 months.
    6) Up to 12 months.
    7) An average of approximately 24 months.
    8) An average of approximately 24 months.
    9) An average of approximately 24 months.
    1. średnio około 18 miesięcy
    2. średnio około 18 miesięcy
    3. średnio około 18 miesięcy
    4. do 12 miesięcy
    5. średnio około 30 miesięcy
    6. do 12 miesięcy
    7. średnio około 24 miesięcy
    8. średnio około 24 miesięcy
    9. średnio około 24 miesięcy
    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 No
    E.6.10Pharmacogenetic Yes
    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 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 No
    E.8.2.4Number of treatment arms in the trial7
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Brazil
    Canada
    Czech Republic
    Korea, Republic of
    Poland
    Russian Federation
    Taiwan
    United States
    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 the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last participant in the study.
    Koniec badania („zakończenie badania”) definiuje się jako datę ostatniej wizyty/oceny określonej w protokole (w tym kontaktu telefonicznego) dla ostatniego uczestnika badania.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 280
    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 intervention is planned after the end of the study. However, provisions will be in place for patients still ongoing at the end of the study to continue to receive IP if, in the opinion of the Investigator, they are continuing to receive benefit from treatment.
    Po zakończeniu badania nie planuje się dalszej terapii. Jednakże zostanie zapewniona możliwość otrzymywania badanego produktu leczniczego przez pacjentów, którzy pod koniec trwania badania, w opinii badacza, nadal odnoszą korzyści z leczenia.
    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 Decision2020-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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