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    Summary
    EudraCT Number:2020-000138-16
    Sponsor's Protocol Code Number:D601HC00002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-000138-16
    A.3Full title of the trial
    A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of
    Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma (ADAGIO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Adavosertib as Treatment for Uterine Serous Carcinoma
    A.3.2Name or abbreviated title of the trial where available
    ADAGIO
    A.4.1Sponsor's protocol code numberD601HC00002
    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.5.6E-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 nameAdavosertib capsule
    D.3.2Product code AZD1775
    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 INNAdavosertib
    D.3.9.1CAS number 1277170-60-1
    D.3.9.2Current sponsor codeAZD1775
    D.3.9.3Other descriptive nameAZD1775 hemihydrate; L001739996-008U; MK-1775
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 nameAdavosertib capsule
    D.3.2Product code AZD1775
    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 INNAdavosertib
    D.3.9.1CAS number 1277170-60-1
    D.3.9.2Current sponsor codeAZD1775
    D.3.9.3Other descriptive nameAZD1775 hemihydrate; L001739996-008U; MK-1775
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent or persistent Uterine Serous Carcinoma (USC) in patients who have previously
    received at least 1 prior platinum-based chemotherapy regimen for the treatment of USC
    E.1.1.1Medical condition in easily understood language
    Cancer of the uterus
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038604
    E.1.2Term Reproductive system and breast disorders
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of adavosertib by the assessment of objective response rate (ORR).
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy of adavosertib by assessment of Duration of Response (DoR)
    - To evaluate efficacy of adavosertib by assessment of depth of response.
    - To evaluate the efficacy of adavosertib by assessment of Progression-Free Survival (PFS).
    - To evaluate the efficacy of adavosertib by assessment of Proportion of patients alive and progression free at 6 months (PFS6)
    - To evaluate the efficacy of adavosertib by assessment of Overall Survival (OS)
    - To evaluate the efficacy of adavosertib by assessment of Disease Control Rate (DCR)
    - To evaluate the pharmacokinetics of Adavosertib
    - To assess the safety and tolerability of adavosertib in participants with USC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent and has given signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    2. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
    3. Participant must be aged ≥ 18 years of age inclusive, at the time of signing the informed consent
    4. Histologically confirmed recurrent or persistent USC. For the purposes of this study, participants with endometrial carcinoma of mixed histology where the serous component comprises at least 10% of the tumour will be considered eligible. Participants with carcinosarcomas are not eligible.
    5. Evidence of measurable disease as per RECIST v1.1 defined as at least one lesion, not previously irradiated, that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with computed tomography (CT) scan or magnetic resonance imaging (MRI) (except lymph nodes which must have short axis ≥ 15 mm) and which is suitable for accurate repeated measurements
    6. At least 1 prior platinum-based chemotherapy regimen for the management of USC (there is no restriction on the number of prior lines of systemic therapy that a participant may have previously received, and the platinum-based chemotherapy may have been given in the adjuvant setting). Chemotherapy administered only in conjunction with primary radiotherapy as a radiosensitiser should not count as a systemic regimen.
    Prior anticancer therapies (immune checkpoint inhibitors, vascular endothelial growth factor (VEGF) inhibitors and HER2 targeted therapy) are allowed.
    Participants who have known MSI-H or dMMR tumours will not be eligible unless they have already received prior therapy with pembrolizumab or another PD-1/PD-L1 immune checkpoint inhibitor, in territories where this treatment is available for this indication, or are deemed not to be a candidate for immune checkpoint therapy.
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    8. Life expectancy ≥ 12 weeks.
    9. Participants must have normal organ and marrow function at baseline, as defined below by laboratory values within 7 days prior to study drug(s) administration:
    - Absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L
    - Haemoglobin (Hb) ≥ 9 g/dL
    - Platelet count ≥ 100 × 10^9 /L
    - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if known hepatic metastases
    - Serum bilirubin within normal limits (WNL) or ≤ 1.5 x ULN in patients with liver metastases; or total bilirubin ≤ 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert’s Syndrome
    - Serum creatinine ≤ 1.5 x ULN, or measured creatinine clearance (CrCl) ≥ 45 mL/min as estimated using either the Cockcroft-Gault method, a 24-hour urine test or another validated test as per local practice (confirmation of creatinine clearance is only required when creatinine is > 1.5 x institutional ULN)
    10. Consent to submit and provide a mandatory FFPE tumour sample for central testing. The site must confirm that the FFPE sample is available prior to dosing
    11. Female patients who are not of childbearing potential and women of childbearing potential who agree to use adequate contraceptive measures from the time of signing the ICF and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test during screening and confirmed on Cycle 1, Day 1 (prior to the start of study treatment)
    E.4Principal exclusion criteria
    1. Any underlying medical condition that would impair the ability of the participant to receive study treatment, as judged by the investigator.
    2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    3. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade > 1 toxicity from prior therapy (except alopecia, anorexia or CTCAE grade 2 peripheral neuropathy).
    4. Unable to swallow oral medications
    5. History of another primary malignancy; exceptions include malignancy treated with curative intent and with no known active disease ≥ 5 years prior to first dose, basal cell and squamous cell carcinoma of skin that has undergone potentially curative therapy, and adequately treated carcinoma in situ without evidence of disease.
    6. Spinal cord compression or metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
    7. Patients with current (or within 28 days prior to Cycle 1, Day 1) signs or symptoms of
    bowel obstruction, including sub-occlusive disease, related to underlying disease.
    8. Any of the following cardiac diseases currently or within the last 6 months:
    - Unstable angina pectoris
    - Acute myocardial infarction
    - Congestive heart failure ≥ Class 2 (as defined by New York Heart Association)
    - Conduction abnormality not controlled with pacemaker or medication
    - Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
    9. History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected.
    10. a) Resting corrected QTc interval using the Fridericia formula (QTcF) > 480 msec (as calculated per institutional standards) obtained from an electrocardiogram (ECG) (NOTE: if one ECG demonstrates a QTcF > 480 msec, then a mean QTcF of ≤ 480 msec obtained from 3 ECGs 2-5 minutes apart, is required at study entry), or
    b) congenital long QT syndrome
    11. Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    12. Patients with known active hepatitis (ie, hepatitis B or C):
    - Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
    - Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase
    chain reaction is negative for HCV RNA
    13. Use of anticancer treatment drug ≤ 21 days (≤ 6 weeks for nitrosoureas or mitomycin C) or use of an investigational product within 5 half-lives prior to the first dose of adavosertib. For PD-1/PD-L1 inhibitors, a minimum of 28 days since last dose is required.
    Patients on luteinising-hormone releasing hormone analogue treatment for more than 6 months are allowed entry into the study and may continue at the discretion of the investigator.
    14. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of bone marrow within 4 weeks prior to the first dose of study intervention
    15. Major surgical procedures ≤ 28 days, or minor surgical procedures ≤ 7 days, prior to beginning study treatment. No waiting period required following port-a-cath or other central venous access placement.
    16. Prior receipt of a cell cycle checkpoint inhibitor (eg, CHK1, WEE1, or ATR inhibition)
    17. Has had prescription or non-prescription drugs or other products known to be moderate to strong inhibitors/inducers of CYP3A4. If the drug could be discontinued, then a wash out of ≥2 weeks prior to Day 1 of dosing is required and the drug will be withheld throughout the study until 2 weeks after the last dose of study drug.
    18. Use of herbal medications 7 days prior to first dose of study treatment.
    19. Participants with a known hypersensitivity or contraindication to adavosertib or any of the excipients of the product.
    20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
    staff and/or staff at the study site).
    21. Judgment by the investigator that the participant should not participate in the study if the
    participant is unlikely to comply with study procedures, restrictions and requirements
    22. Previous enrolment in the present study.
    23. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) is defined as the proportion of participants with measurable disease at baseline who have a confirmed complete response (CR) or partial response (PR), as determined by Blinded Independent Central Review (BICR) per RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After start of treatment (Cycle 1, Day 1), scans will be repeated every 6 weeks (±7 days) for the first 48 weeks and every 9 weeks (±7 days) thereafter, until objective radiological disease progression by investigator assessment using RECIST v1.1.
    E.5.2Secondary end point(s)
    1. Duration of Response (DoR) is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR), or death in the absence of disease progression.
    2. Depth of response is defined as the best percentage change from baseline in Target Lesions.
    3. Progression-free survival (PFS) is defined as time from date of first dose until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
    4. DCR is defined as the percentage of participants who have a best overall response of CR (complete response) or PR (partial response) or who have stable disease for at least 5 weeks after start of treatment (to allow for an early
    assessment within the assessment window)
    5. Overall survival (OS) is defined as time from date of first dose until the date of death due to any cause
    6. Progression free at 6 months (PFS6) is defined as the proportion of participants alive and progression free at 6 months, and will be reported as the Kaplan-Meier estimate of PFS per RECIST v1.1 as assessed by BICR at 6 months
    7. Plasma concentration of adavosertib
    8. Safety will be evaluated in terms of AEs, vital signs, clinical laboratory assessments, ECGs, and AEs leading to dose interruptions, dose reductions, and dose discontinuations.
    Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as heart rate, body temperature, body weight, height, and BMI.
    Laboratory parameters include clinical chemistry and haematology parameters as well as urinalysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6: After start of treatment (Cycle 1, Day 1), scans will be repeated every 6 weeks (±7 days) for the first 48 weeks and every 9 weeks (±7 days) thereafter, until objective radiological disease progression by investigator assessment using RECIST v1.1.
    7: Pre dose and 2 hours post dose on Day 5 of Cycles 1 and 2
    8: From baseline to post treatment follow-up (30 days after last dose)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Samples collected for the Genomic initiative are considered primary use and will be whole exome or whole genome sequenced. Analysis will be performed for both known and novel health related genes
    and this broad genetic research will not restrict to disease or drug. Sequencing data generated is for research purposes only and cannot be used for clinical decision making and there will not be any clinical endpoints delivered to the study, as a result of testing performed
    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.8.2.4Number of treatment arms in the trial1
    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 EEA23
    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
    France
    Germany
    Italy
    Spain
    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
    Last subject's last visit
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days19
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    Participants are permitted to continue to receive adavosertib treatment beyond the end of study if, in the opinion of the investigator, they are continuing to receive clinical benefit. Treatment of participants with adavosertib beyond progression is not allowed.
    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 Decision2020-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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