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    Summary
    EudraCT Number:2016-001271-68
    Sponsor's Protocol Code Number:AP32788-15-101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-15
    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 number2016-001271-68
    A.3Full title of the trial
    A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TAK-788 (AP32788) in Patients With Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberAP32788-15-101
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1217-7205
    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 SponsorTakeda Development Center Americas, Inc.
    B.1.3.4CountryUnited States
    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 supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointStudy Registration Call Center
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1866835-2233
    B.5.6E-mailGlobalOncologyMedinfo@takeda.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 nameTAK-788
    D.3.2Product code TAK-788 (formerly AP32788)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot yet assigned.
    D.3.9.1CAS number 1847461-43-1
    D.3.9.2Current sponsor codeTAK-788
    D.3.9.3Other descriptive nameAP32788
    D.3.9.4EV Substance CodeSUB195427
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Non-Small Cell Lung Cancer (NSCLSC)
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer (NSCLSC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 10029522
    E.1.2Term Non-small cell lung 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung 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 LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    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 LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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 efficacy of TAK-788, as evidenced by confirmed ORR, as assessed by the IRC, in patients with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations and who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.
    E.2.2Secondary objectives of the trial
    1. To further characterize the efficacy of TAK-788 as shown by confirmed ORR, as assessed by the investigator, duration of response, progression free survival (PFS), disease control rate (DCR), time to response, and overall survival (OS)
    2. To assess the safety and tolerability of TAK-788
    3. To collect sparse plasma concentration-time data of TAK 788 and its active metabolites, AP32960 and AP32914, to contribute to population PK and exposure response analyses
    4. To assess patient-reported symptoms (particular core symptoms of lung cancer), functioning, and health-related quality of life (HRQoL) with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the EORTC lung cancer module, QLQ-LC13
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    1.Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic disease (Stage IIIB or IV). For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC.
    2.Must have sufficient tumor tissue available for analysis (see Laboratory Manual for specific requirements). For patients in the expansion cohorts and in the extension cohort, tumor tissue obtained after progression on the most recent prior therapy is preferred.
    3.Must have measurable disease by RECIST v1.1 (Appendix B).
    4.Male or female adult patients (aged 18 years or older, or as defined per local regulations).
    5.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix A).
    6.Minimum life expectancy of 3 months or more.
    7.Adequate renal and hepatic function as defined by the following criteria:
    a.Total serum bilirubin ≤1.5 × upper limit of normal (ULN) (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy);
    b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤5 × ULN if liver function abnormalities are due to underlying malignancy);
    c.Estimated creatinine clearance ≥30 mL/min (calculated by using the Cockcroft-Gault equation);
    d.Serum albumin ≥2 g/dL; and
    e.Serum lipase ≤1.5 × ULN; and
    f. Serum amylase ≤1.5 × ULN unless the increased serum amylase is
    due to salivary isoenzymes.
    8.Adequate bone marrow function as defined by the following criteria:
    a.Absolute neutrophil count (ANC) ≥1.5 × 109/L;
    b.Platelet count ≥75 × 109/L; and
    c.Hemoglobin ≥9.0 g/dL.
    9.Normal QT interval on screening electrocardiogram (ECG), defined as QTcF of ≤450 ms in males or ≤470 ms in females.
    10.All toxicities from prior therapy have resolved to ≤ grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0 [18]), or have resolved to baseline, at the time of first dose of TAK 788. Note: treatment-related grade >1 alopecia or treatment-related grade 2 peripheral neuropathy are allowed if deemed irreversible.
    11.Female patients who:
    •Are postmenopausal for at least 1 year before the screening visit, OR
    •Are surgically sterile, OR
    •If they are of childbearing potential, agree to practice 1 highly effective, nonhormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, OR
    •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
    Male patients, even if surgically sterilized (ie, status postvasectomy), who:
    •Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR
    •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)

    Extension Phase specific
    1.Have a documented EGFR in-frame exon 20 insertion (including A763_Y764insFQEA, V769_D770insASV, D770_N771insNPG, D770_N771insSVD, H773_V774insNPH, or any other in-frame exon 20 insertion mutation) assessed by a Clinical Laboratory
    Improvements Amendment (CLIA)-certified (United States [US] sites) or an accredited (outside of the US) local laborato and sufficient tumor tissue available for central analysis (see Laboratory Manual). The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations. Note: central confirmation is not required for enrollment.
    2. Must have received at least 1 prior line of therapy for locally advanced or metastatic disease and no more than 2 regimens of systemic anticancer chemotherapies for locally advanced or metastatic disease.
    –Note: A systemic anticancer chemotherapy regimen will be counted if it is administered over at least 1 cycle. A new antineoplastic chemotherapy used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer chemotherapy will be counted as a prior regimen if completion of the (neo)adjuvant therapy occurred <12 months prior to enrollment.
    –Prior treatment with an EGFR TKI is allowed unless the patient had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
    E.4Principal exclusion criteria
    1.Previously received TAK-788.
    2.Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) ≤14 days prior to first dose of TAK 788 (except for reversible EGFR TKIs [ie, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of TAK 788).
    3.Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
    4.Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. Note: This exclusion criterion does not apply to Expansion Cohort 7.
    5.Received radiotherapy ≤14 days prior to the first dose of TAK 788 or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, SRS, and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose.
    6.Received a moderate or strong CYP3A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of TAK 788 (see Appendix C).
    7.Have undergone major surgery within 28 days prior to first dose of TAK 788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
    8.Have symptomatic CNS metastases at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK 788.
    Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions). Brain metastases are allowed if they have
    been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of TAK-788, and have no evidence of new or enlarging brain metastases.
    9. Have currentut who receive prophylactic steroids or anticonvulsants are allowed.
    9.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
    10.Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:
    a.Myocardial infarction (MI) within 6 months prior to the first dose of study drug;
    b.Unstable angina within 6 months prior to first dose;
    c.Congestive heart failure (CHF) within 6 months prior to first dose;
    d.History of clinically significant (as determined by the treating physician) atrial arrhythmia;
    e.Any history of ventricular arrhythmia; or
    f.Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose.
    11.Have a known history of uncontrolled hypertension. Patients with hypertension should be under treatment on study entry to control blood pressure.
    12.Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes (Appendix D).
    13.(Parts 1 and 2 [dose escalation and expansion cohorts] only) Have an ongoing or active infection including, but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.
    (Part 3 [extension cohort] only) Have an ongoing or active infection including, but not limited to, the requirement for IV antibiotics, or a known history of HIV. Testing is not required in the absence of history.
    (Part 3 [extension cohort] only) Hepatitis B surface antigen (HBsAg) positive patients are allowed to enroll if HBV DNA is below 1000 copies/mL in the plasma. Patients who are positive for anti-HCV antibody (HCVAb) can be enrolled but must not have detectable HCV RNA in the plasma.
    14.Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
    15.Female patients who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period. Note: Female patients who are lactating will be eligible if they discontinue breastfeeding.
    16.Have gastrointestinal illness or disorder that could affect oral absorption of TAK 788.
    17.Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed ORR, as assessed by the IRC, per RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the primary endpoint, confirmed ORR as assessed by the IRC, will be performed in the full analysis set when all ongoing patients have completed their Cycle 6 disease assessment. A futility analysis will be planned for the primary endpoint when approximately 20 patients have completed their Cycle 4 disease assessment.
    E.5.2Secondary end point(s)
    1.Confirmed ORR, as assessed by the investigator, per RECIST v1.1
    2.Duration of response, as assessed by the IRC and the investigator
    3.Time to response, as assessed by the IRC and the investigator
    4.DCR (the percentage of patients with best response of complete response [CR], partial response [PR], or SD), as assessed by the IRC and the investigator, per RECIST v1.1
    5.PFS, as assessed by the IRC and the investigator
    6.OS
    7.Patient-reported symptoms (particular core symptoms of
    lung cancer), functioning, and HRQoL with the EORTC QLQ-C30 and QLQ-LC13
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two-sided exact 95% binomial confidence intervals will be computed for all binary secondary endpoints, including confirmed ORR as assessed by the investigator and DCR as assessed by the IRC and the investigator. Kaplan Meier methods, including medians and confidence intervals, will be used to estimate PFS as assessed by the IRC and the investigator, duration of response as assessed by the IRC and the investigator, and OS. Descriptive statistics will be used to summarize time to response in responders and time on treatment. Patient-reported outcome assessments will be assessed at each cycle using descriptive summary statistics.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    China
    Japan
    Korea, Republic of
    Taiwan
    United States
    Spain
    Germany
    Italy
    United Kingdom
    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
    End of study (completion) date is 3 years after the last patient has enrolled unless stopped earlier due to futility or sponsor decision..
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 91
    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)
    Subjects will revert to standard clinical management as directed by attending personal physician.
    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 Decision2019-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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