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    Summary
    EudraCT Number:2017-005057-36
    Sponsor's Protocol Code Number:GLG-801-07
    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:2018-03-28
    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 number2017-005057-36
    A.3Full title of the trial
    A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability and Recommended Phase II Dose (RP2D) of GLG-801 in patients with Advanced Solid Tumors (Phase I); and safety, tolerability and anticancer activity of GLG-801 in patients with Metastatic TNBC (Phase II).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability and Recommended Phase II Dose (RP2D) of GLG-801 in patients with Advanced Solid Tumors (Phase I); and safety, tolerability and anticancer activity of GLG-801 in patients with Metastatic TNBC (Phase II).
    A.4.1Sponsor's protocol code numberGLG-801-07
    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 SponsorGLG Pharma S.A.
    B.1.3.4CountryPoland
    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 supportGLG Pharma S.A
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGLG Pharma S.A
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressDunska 9 St.
    B.5.3.2Town/ cityWroclaw
    B.5.3.3Post code54-427
    B.5.3.4CountryPoland
    B.5.6E-mailoffice@glgpharma.pl
    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 Daraprim
    D.2.1.1.2Name of the Marketing Authorisation holderGSK The Wellcome Foundation Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code GLG-801
    D.3.4Pharmaceutical form Tablet
    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 INNPYRIMETHAMINE
    D.3.9.1CAS number 58-14-0
    D.3.9.4EV Substance CodeSUB10169MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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
    Metastatic triple-negative breast cancer
    Breast cancer, prostate cancer, ovarian cancer, head and neck cancer, NSCLC, colorectal cancer, gastric cancer, esophageal cancer, bladder cancer, renal cell carcinoma or melanoma
    E.1.1.1Medical condition in easily understood language
    Breast cancer, prostate cancer, ovarian cancer, head and neck cancer, NSCLC, colorectal cancer, gastric cancer, esophageal cancer, bladder cancer, renal cell carcinoma or melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010030
    E.1.2Term Colorectal 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10017761
    E.1.2Term Gastric 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10005005
    E.1.2Term Bladder 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038390
    E.1.2Term Renal 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10066600
    E.1.2Term Melanoma 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    • To evaluate safety and tolerability of escalating dose levels of GLG-801 in adult patients with advanced, refractory, solid tumors.
    • To determine RP2D based on MTD.
    Phase II
    • To determine the response (radiologic ORR), in patients with metastatic TNBC (based on Recist 1.1. Criteria)
    • To confirm the safety and tolerability of GLG-801 in patients with advanced TNBC at RP2D as determined in Phase I portion of this study.
    E.2.2Secondary objectives of the trial
    Phase I
    To assess steady state serum concentration of GLG-801 - doses 50, 75 and 100 mg administrated once daily
    Phase II
    Proteomic analysis cancer samples - detection of proteins in tissue samples (20 subsets of biopsies of 60 patients; pre- and post-treatment), including 1. Basic analysis: HER2, ER (estrogen receptor), PR (progesterone receptor), STAT3 (cytoplasmic/nuclear/total) p-STAT3. 2. Proliferation markers:Ki-67; Cyclin D1. 3. Downstream markers of STAT3 activation Survivin, PDL-1. 4. TNBC markers:CK17, EGFR
    To evaluate whether GLG-801 modifies STAT3 (cytoplasmic/nuclear/total) and p-STAT3 levels in tumor biopsy specimens and/or in CTCs
    To evaluate CTCs level
    To evaluate effect of concentration at steady state on STAT3 inhibition and overall response as well as to assess GLG-801 levels overtime
    To evaluate whether GLG-801 clinical activity is dependent on TNBC subtype
    To evaluate whether baseline STAT3 activity in cancer tissue/CTCs predicts response to GLG-801
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase I
    Patients must meet the following criteria to enter the study:
    1) Men or women at least 18 years of age;
    2) Eastern Cooperative Oncology Group performance status ≤ 2;
    3) Females must be surgically sterile or at least 1 year post-menopausal. Women of childbearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 3 months following the last dose of study drug. Acceptable methods of contraception include non-hormonal intrauterine device and barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide. Female patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study or if they become sexually active, they must agree to use effective methods of birth control as described above.
    4) Males, if sexually active, must be either surgically sterile, or agree to be abstinent or use an effective method of birth control (condom with spermicide) through 3 months after the last dose of GLG-801;
    5) Life expectancy of at least 3 months;
    6) Have one of the following cancers with prior histologic confirmation breast, prostate, ovarian, head and neck, NSCLC, colorectal, gastric, esophageal, bladder, renal cell or melanoma, that has been refractory to two or more standard systemic treatment regimens for their disease with ability to collect tumor biopsy (primary or metastases) during screening period and in further observation according to protocol;
    7) Be at least 30 days since the last dose of any prior chemotherapy regimen or other anticancer agent(s), and has had all toxicities caused by prior therapy resolve or no greater than grade 1 by the NCI Common Terminology for AE criteria before Day 1;
    8) Subject is able to swallow and retain oral medication and does not have uncontrolled emesis;
    9) Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits.
    Phase II
    Patients must meet the following criteria to enter the study:
    1) Women at least 18 years of age
    2) Eastern Cooperative Oncology Group performance status ≤ 2
    3) Must be surgically sterile or at least 1 year post-menopausal. Women of childbearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 3 months following the last dose of study drug. Acceptable methods of contraception include non-hormonal intrauterine device and barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide. Patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study or if they become sexually active, they must agree to use effective methods of birth control as described above
    4) Life expectancy of at least 3 months
    5) Have metastatic triple-negative breast cancer following failure of at least two lines of chemotherapy for disseminated disease
    6) Be at least 30 days since the last dose of any prior chemotherapy regimen or other anticancer agent(s), and has had all toxicities caused by prior therapy resolve or no greater than grade 1 by the NCI Common Terminology for AE criteria before Day 1
    7) Subject is able to swallow and retain oral medication and does not have uncontrolled emesis
    8) Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits
    9) Must be able to confirm TNBC diagnosis by providinge archival pathological material from primary or metastatic site
    E.4Principal exclusion criteria
    1) Receipt of GLG-801 in any previous clinical study;
    2) History of allergy or reaction to any component of the GLG-801 formulation;
    3) Received palliative local or bone lesion radiation within 30 days prior to visit Day1;
    4) History of malignancy other than those listed under inclusion criteria;
    5) Hemoglobin ≤ 10.0 g/dL, platelets < 100.0 × 109/L; or neutrophils ≤ 1500 / mm3
    6) Hepatic function: AST ≥ 2.5 × upper limit of normal (ULN); ALT ≥ 2.5 × ULN, bilirubin ≥ 1.5 × ULN. For subjects with liver metastases, AST > 5 × ULN range; ALT > 5 × ULN range. Subjects with Gilbert's syndrome may have a bilirubin ≥ 1.5 × ULN, if no evidence of biliary obstruction exists;
    7) Folic acid level below normal reference ranges before Day 1;
    8) Abnormal values of any of the screening coagulation tests (PT, AT, INR) by the local laboratory normal criteria, or receiving anticoagulant therapy for thromboembolic disease;
    9) Clinical history of significant central nervous system (CNS) pathology, e.g., primary or secondary brain cancer, uncontrolled headaches, multiple occurrences of confusion, dementia, multiple previous infarcts, or major brain surgery;
    10) Any known psychiatric conditions;
    11) History of seizures;
    12) Active infection or known bacteremia requiring antimicrobial therapy within 2 weeks prior to initiation of GLG-801;
    13) Vaccination (either preventive or therapeutic for infectious disease or cancer) within 2 weeks prior to initiation of GLG-801;
    14) Infection with human immunodeficiency virus (HIV-1 or HIV-2), acute or chronic infection with hepatitis B or C, or acute infection with hepatitis A;
    15) History of serious, chronic autoimmune disease, eg, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis; or autoimmune hemolytic anemia or thrombocytopenia;
    16) Elective surgery planned during the study period through 30 days after discontinuation of GLG-801;
    17) Autologous or allogenic stem cell or bone marrow transplant; or any solid organ transplant;
    18) Chronic or regular dosing with a systemic prednisone exceeding 10 mg/day or equivalent, or any other systemic immunosuppressive therapy, during 4 weeks prior to initiation of GLG-801 or anticipated need during the trial;
    19) Any finding upon physical examination or history of any disease or behavior that, in the opinion of the investigator or medical monitor, that may compromise the safety of the patient in the study, interfere with compliance to the protocol, or confound the analysis of the study including known active abuse of drugs or alcohol;
    20) Subjects with active brain metastases or leptomeningeal disease at screening must have clinically controlled neurologic symptoms and have received previous adequate treatment, defined as surgical excision and/or radiation therapy with stable neurologic function and no evidence of CNS disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids;
    21) Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
    22) Symptomatic pleural effusion or ascites requiring periodic paracentesis;
    23) Respiratory insufficiency requiring oxygen therapy;
    24) History of acute myocardial infarction, stroke, transient ischemic attack, or symptomatic cardiac arrhythmia within 6 months prior to the anticipated date of the first dose of study drug;
    25) Uncontrolled hypertension (BP > 150 SBP or >95 DBP), or uncontrolled or symptomatic angina, congestive heart failure or clinically significant cardiac arrhythmia 

    26) Received another investigational drug within 30 days prior to the anticipated date of receiving the study drug;
    27) Pregnancy and breastfeeding;
    28) Inability to meet social or environment requirements for outpatient therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    1. Evaluation of safety and tolerability (% dropout) of escalating dose levels of GLG-801
    2. Determination of RP2D based on MTD
    Phase II
    1. Determination of the response (radiologic ORR), in patients with metastatic TNBC (based on Recist 1.1. Criteria)
    2. Confirmation of the safety and tolerability of GLG-801 in patients with advanced TNBC, at RP2D as determined in Phase I portion of this study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29, Day 85
    E.5.2Secondary end point(s)
    Phase I
    1. Assessment of steady state serum concentration of GLG-801 with the three different doses 50, 75 and 100 mg administrated once daily
    Phase II
    1. Proteomic analysis cancer samples - detection of proteins in tissue samples (biopsies in a subset of 20 of the planned 60 patients, pre- and post-treatment), including
    a. Basal detection: HER2, ER (estrogen receptor), PR (progesterone receptor), STAT3 (cytoplasmic/nuclear/total), p-STAT3
    b. Proliferation markers: Ki-67; Cyclin D1
    c. Downstream markers of STAT3 activation Survivin, PDL-1
    d. TNBC markers: CK17, EGFR
    2. Evaluation of GLG-801 effect on STAT3 (cytoplasmic, nuclear or total), p-STAT3 in tumor samples and/or in circulating tumor cells (CTCs), percentage of pSTAT3 positive cells STAT3 and pSTAT3 levels in all detected CTCs,
    3. CTCs level
    4. Assessment of GLG-801 levels during treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29, Day 85
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    RP2D
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    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
    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 Decision2018-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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