protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02799602 | 9.4 | Efficacy | 9.4 Efficacy The primary efficacy variable is OS.  26 MAY 2020 Version 5.0 Page: 62 of 108 Survival status will be assessed from randomization until the end of the Long–term Follow-up period. Date of death and primary cause of death will be recorded. For definition and analysis of primary variab... | [] |
NCT02799602 | 9.5 | Pharmacokinetics/pharmacodynamics | 9.5 Pharmacokinetics/pharmacodynamics | [] |
NCT02799602 | 9.5.1 | Drug measurements | 9.5.1 Drug measurements The concentrations of diastereomers (S,R)-darolutamide (BAY 1896951) and (S,S)-darolutamide (BAY 1896952), metabolite keto-darolutamide (BAY 1896953) and docetaxel in plasma will be determined by a validated method, e.g. liquid chromatography– tandem mass spectrometry (LC–MS/MS). Darolutamide (B... | [] |
NCT02799602 | 9.5.2 | Pharmacokinetic evaluation | 9.5.2 Pharmacokinetic evaluation
Non–compartment approach PK analysis In the first 20 subjects who were randomized and have received at least 1 cycle of docetaxel: Pharmacokinetic parameters will be calculated using a non–compartment approach according to the current Bayer guidelines, using Win–Nonlin software. Detail... | [
"Non–compartment approach PK analysis",
"Main parameter:",
"Additional parameters:",
"Population PK evaluation"
] |
NCT02799602 | 9.6.1.1 | Definitions | 9.6.1.1 Definitions
Definition of adverse event In a clinical study, an AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written IC for participation in the study... | [
"Definition of adverse event",
"Definition of a serious adverse event"
] |
NCT02799602 | 9.6.1.2 | Classifications for adverse event assessment | 9.6.1.2 Classifications for adverse event assessment All AEs will be assessed and documented by the Investigator according to the categories detailed below. | [] |
NCT02799602 | 9.6.1.2.1 | Seriousness | 9.6.1.2.1 Seriousness For each AE, the seriousness must be determined according to the criteria given in Section [9.6.1.1.](#page-64-0) | [] |
NCT02799602 | 9.6.1.2.2 | Intensity | 9.6.1.2.2 Intensity The severity (or intensity) of AEs should be documented using NCI–CTCAE v 4.03. If no exact matching code is available in NCI–CTCAE v 4.03, the following guide should be used: - CTC 1 = Mild AE: Transient in nature and generally not interfering with normal activities - CTC 2 = Moderate AE: Sufficien... | [] |
NCT02799602 | 9.6.1.2.3 | Causal relationship | 9.6.1.2.3 Causal relationship The assessment of the causal relationship between an AE and the administration of treatment is a clinical decision based on all available information at the time of the completion of the eCRF. The causal relationship should be assessed to darolutamide/placebo as well as the background doce... | [
"Causal relationship to protocol–required procedure(s)]"
] |
NCT02799602 | 9.6.1.2.4 | Action taken with study treatment | 9.6.1.2.4 Action taken with study treatment Any action on study treatment to resolve the AE is to be documented using the categories listed below: - Drug withdrawn - Drug interrupted - Dose reduced - Dose not changed - Not applicable - Unknown | [] |
NCT02799602 | 9.6.1.2.5 | Other specific treatment(s) of adverse events | 9.6.1.2.5 Other specific treatment(s) of adverse events None  26 MAY 2020 Version 5.0 Page: 68 of 108 - Remedial drug therapy - Other | [] |
NCT02799602 | 9.6.1.2.6 | Outcome | 9.6.1.2.6 Outcome The outcome of the AE is to be documented using the following categories: - Recovered/resolved - Recovering/resolving - Recovered/resolved with sequelae - Not recovered/not resolved - Fatal - Unknown | [] |
NCT02799602 | 9.6.1.3 | Assessments and documentation of adverse events | 9.6.1.3 Assessments and documentation of adverse events All AEs occurring from the time the subject has signed the ICF until 30 (+7) days after the last dose of study drug must be entered in the subject's eCRF. All treatment–emergent AEs must be followed until resolution or stabilization, wherever feasible. The type of... | [] |
NCT02799602 | 9.6.1.4 | Reporting of serious adverse events | 9.6.1.4 Reporting of serious adverse events The definition of SAEs is given in Section [9.6.1.1.](#page-64-0) Each SAE must be followed up until resolution or stabilization by submission of updated reports to the designated recipient.  26 MAY 2020 Version 5.0 Page: 69 of 108
Investigator's noti... | [
"Investigator's notification of the Sponsor",
"Notification of the IECs / IRBs",
"Notification of the authorities",
"Sponsor's notification of the investigational site"
] |
NCT02799602 | 9.6.1.5 | Expected adverse events | 9.6.1.5 Expected adverse events For this study, the applicable reference document is the most current version of the IB. Overview listings of frequent events that have occurred so far in the clinical development are shown in the current IB. If relevant new safety information is identified, the information will be integ... | [] |
NCT02799602 | 9.6.1.6 | Adverse events of special safety interest | 9.6.1.6 Adverse events of special safety interest None. | [] |
NCT02799602 | 9.6.2 | Pregnancies | 9.6.2 Pregnancies Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment with dar... | [] |
NCT02799602 | 9.6.3 | Further safety | 9.6.3 Further safety | [] |
NCT02799602 | 9.6.3.1 | Laboratory safety assessments | 9.6.3.1 Laboratory safety assessments The PSA and testosterone values are to be assessed by a central laboratory during the study period. Blood samples to test alkaline phosphatase for stratification purpose will be analyzed in central laboratory and thereafter by local laboratory. Other laboratory assessments are to b... | [
"Hematology:",
"Chemistry:",
"Urinalysis:"
] |
NCT02799602 | 9.6.3.2 | Physical examination | 9.6.3.2 Physical examination Physical examination will be performed and weight will be measured at all visits (except at Day 1 Visit if already performed at Screening). Height will be recorded at Screening only. Abnormal physical examination findings are recorded either as medical history or as AEs (see Section [9.6.1.... | [] |
NCT02799602 | 9.6.3.3 | 12–lead ECGs | 9.6.3.3 12–lead ECGs All 12–lead ECGs will be recorded in a supine position after at least 10 minutes rest. | [] |
NCT02799602 | 9.6.3.4 | Vital signs | 9.6.3.4 Vital signs All vital sign assessments will be recorded in a supine position after at least 10 minutes rest. | [] |
NCT02799602 | 9.7 | Other procedures and variables | 9.7 Other procedures and variables Other exploratory variables in this study are pain intensity and pain interference scores from the BPI–SF, medical resource use, and assessment of biomarkers.  26 MAY 2020 Version 5.0 Page: 73 of 108 In addition to calculating a pain score based on the worst pa... | [] |
NCT02799602 | 9.7.1 | Biomarker investigations | 9.7.1 Biomarker investigations Biomarker status will be correlated with clinical outcome to explore whether any biological targets appear to define subject populations that are particularly sensitive or resistant to darolutamide. Details of the biomarker analyses may be described in a separate statistical analysis plan... | [] |
NCT02799602 | 9.7.1.1 | Plasma–based biomarker analysis | 9.7.1.1 Plasma–based biomarker analysis Subjects will be asked to provide blood samples for biomarker analyses, which will be obtained during regular study visits in which blood will be drawn for other scheduled but unrelated laboratory tests.
Genetic biomarkers from plasma: These samples are intended to isolate plasm... | [
"Genetic biomarkers from plasma:",
"Non–genetic biomarkers from plasma:"
] |
NCT02799602 | 9.7.1.2 | Circulating tumor cells | 9.7.1.2 Circulating tumor cells CTCs may serve as source of tumor metastases circulating in blood and may reflect the tumor phenotype or genotype. Enumeration of CTCs may serve as description of tumor burden. Circulating tumor cells will be analyzed in detail from whole blood samples collected at various time points to... | [] |
NCT02799602 | 9.7.1.3 | Tumor–based biomarker analysis | 9.7.1.3 Tumor–based biomarker analysis From subjects for which tumor tissue specimens (e.g. from biopsy) are available, tumor specific biomarker analyses are intended to be used for the following purposes: (1) to evaluate mutations, copy numbers or gene rearrangements in known oncogenes such as AR, TMPRSS, cMYC, PI3K, ... | [] |
NCT02799602 | 9.7.1.4 | Genetic biomarker analysis from whole blood | 9.7.1.4 Genetic biomarker analysis from whole blood Biomarkers related to drug safety, efficacy, or mechanism of action may be analyzed from whole blood and involve targeted pharmacogenetic testing. These studies will conducted aiming to find gene variants associated with responses to darolutamide treatment and to pred... | [] |
NCT02799602 | 9.7.2 | Medical resource use | 9.7.2 Medical resource use Information on medical resource use (e.g. hospitalization visits, physician visits etc.) that is associated with the management of AEs as well as non–protocol–driven subject monitoring will be collected by e–CRF that is completed by the physician at each visit. | [] |
NCT02799602 | 9.7.3 | Subject–reported outcomes | 9.7.3 Subject–reported outcomes For this study, health–related QoL will be measured using the NCCN–FACT FPSI–17 questionnaire. The NCCN–FACT FPSI–17 is a validated instrument that was developed to assess symptoms of prostate cancer, symptoms of treatment of prostate cancer, and health related QoL of prostate cancer sub... | [] |
NCT02799602 | 9.8 | Appropriateness of procedures / measurements | 9.8 Appropriateness of procedures / measurements All efficacy and safety parameters, as well as the methods to measure them, are standard variables /methods in clinical studies and/or clinical practice. They are widely used and generally recognized as reliable, accurate, and relevant. The NCCN–FACT FPSI–17 is a validat... | [] |
NCT02799602 | 10 | Statistical methods and determination of sample size | 10. Statistical methods and determination of sample size | [] |
NCT02799602 | 10.1 | General considerations | 10.1 General considerations Statistical analysis will be performed using SAS; the version used will be specified in the SAP. | [] |
NCT02799602 | 10.2 | Analysis sets | 10.2 Analysis sets Full analysis set (FAS): All randomized subjects. The FAS will be used in the analysis of all efficacy endpoints. Subjects will be included in FAS according to the treatment to which they are randomized. Safety analysis set (SAF): All randomized subjects who have received at least 1 dose of study dru... | [] |
NCT02799602 | 10.3 | Variables and planned statistical analyses | 10.3 Variables and planned statistical analyses The complete list of variables to be analyzed for this study will be provided in the SAP. | [] |
NCT02799602 | 10.3.1 | Primary efficacy variable | 10.3.1 Primary efficacy variable The primary efficacy variable is OS, defined as the time (in days) from date of randomization until death from any cause.
Analysis of OS All randomized subjects (FAS) will be included in the primary analysis of OS, the primary efficacy endpoint. The analysis will be performed when appr... | [
"Analysis of OS"
] |
NCT02799602 | 10.3.2 | Secondary efficacy variables | 10.3.2 Secondary efficacy variables The secondary efficacy variables include: - Time to castration–resistant prostate cancer, defined as the time to PSA progression (Section [10.3.4](#page-80-0)) with serum testosterone being at castrate level 0 at baseline), pain progression is defined as an increase of 2 or more poin... | [
"Secondary efficacy variables analysis"
] |
NCT02799602 | 10.3.3 | Safety variables | 10.3.3 Safety variables The safety variables include: - AEs until the end–of–study treatment visit - SAEs until the end–of–study treatment visit - Study drug–related SAEs until the end of Long–term Follow–up - Vital signs: BP and heart rate (HR) - 12–lead electrocardiogram (ECG) - Physical examination - Laboratory safe... | [
"Safety analysis"
] |
NCT02799602 | 10.3.4 | Other exploratory variables | 10.3.4 Other exploratory variables
Rate of absolute PSA response at 6 and 12 months Absolute PSA response is defined as blood PSA level <0.2 ng/mL, confirmed by a second subsequent PSA value <0.2 ng/mL 3 or more weeks later. Rate of absolute PSA response is defined as the number of subjects with absolute PSA response,... | [
"Rate of absolute PSA response at 6 and 12 months",
"Rate of relative PSA response at 3, 6 and 12 months",
"Time to PSA progression",
"Missing data / drop outs"
] |
NCT02799602 | 10.3.5 | Pharmacokinetics | 10.3.5 Pharmacokinetics
Pharmacokinetics in the first 20 subjects who were randomized and have received at least 1 cycle of docetaxel The concentration–time courses of all substances will be tabulated separated by treatment. The following statistics will be calculated for each of the sampling points: arithmetic mean, ... | [
"Pharmacokinetics in the first 20 subjects who were randomized and have received at least 1 cycle of docetaxel",
"Pharmacokinetics in all subjects"
] |
NCT02799602 | 10.3.6 | Biomarker analyses | 10.3.6 Biomarker analyses Results from exploratory biomarker studies will be reported in a separate biomarker report.  26 MAY 2020 Version 5.0 Page: 82 of 108 | [] |
NCT02799602 | 10.3.7 | Medical Resource use | 10.3.7 Medical Resource use Medical resource use is described in Section [9.7.2](#page-75-1). | [] |
NCT02799602 | 10.3.8 | Subject–reported outcomes | 10.3.8 Subject–reported outcomes Subject–reported outcome procedures are described in Section [9.7.3.](#page-75-0) | [] |
NCT02799602 | 10.3.9 | Baseline and demographic characteristics | 10.3.9 Baseline and demographic characteristics Baseline and demographic characteristics will be summarized by descriptive statistics by treatment group darolutamide for the FAS population. In addition, exploratory exposure–response analyses of efficacy, PD, or safety parameters, e.g. OS, PSA response rate, etc., are p... | [] |
NCT02799602 | 10.4 | Determination of sample size | 10.4 Determination of sample size The sample size of the study is based on the primary endpoint of OS. The study is designed to have 90% power to detect a 33% increase in median time of OS with darolutamide compared to placebo (from 60 to 80 months, corresponding to a HR of 0.75) with a 1–sided alpha of 0.025. The OS d... | [] |
NCT02799602 | 10.5 | Planned interim analyses | 10.5 Planned interim analyses One formal interim analysis of OS was planned. This interim analysis for futility was to be performed after approximately 153 deaths were observed. The DMC (see Section [13.1.1\)](#page-88-1) was overseeing the interim analysis. Detailed analysis methods and stopping rules will be specifie... | [] |
NCT02799602 | 11 | Data handling and quality assurance | 11. Data handling and quality assurance | [] |
NCT02799602 | 11.1 | Data recording | 11.1 Data recording The data collection tool for this study will be an eCRF; a validated electronic data capture system called RAVE. Subject data necessary for analysis and reporting will be entered/transmitted into a validated database or data system (CIE/TOSCA; SAS). Data required according to this protocol will be r... | [
"Source documentation",
"Data recorded from screening failures"
] |
NCT02799602 | 11.2 | Monitoring | 11.2 Monitoring In accordance with applicable regulations, GCP, and Sponsor's/CRO's procedures, monitors will contact the site prior to the start of the study to review with the site staff the protocol, study requirements, and their responsibilities to satisfy regulatory, ethical, and Sponsor's requirements. When revie... | [] |
NCT02799602 | 11.3 | Data processing | 11.3 Data processing Data will be collected as described in Section [11.1](#page-83-0). Clinical data management will be performed in accordance with applicable Sponsor's/CRO's standards and data cleaning procedures. This is applicable for data recorded on CRF as well as for data from other sources (e.g. IXRS, laborato... | [] |
NCT02799602 | 11.4 | Missing data | 11.4 Missing data The analysis of the primary endpoint is based on the intent to treat population. Subjects who discontinue the treatment prematurely or leave the study prematurely will not be replaced. Handling of missing data, which in this context are events not observed for the time–to–event endpoints (primary vari... | [] |
NCT02799602 | 11.5 | Audit and inspection | 11.5 Audit and inspection To ensure compliance with GCP and regulatory requirements, a member of the Sponsor's (or a designated CRO's) quality assurance unit may arrange to conduct an audit to assess the performance of the study at the study site and of the study documents originating there. The Investigator/institutio... | [] |
NCT02799602 | 11.6 | Archiving | 11.6 Archiving Essential documents shall be archived safely and securely in such a way that ensures that they are readily available upon authorities' request. Subject (hospital) files will be archived according to local regulations and in accordance with the maximum period of time permitted by the hospital, institution... | [] |
NCT02799602 | 12 | Premature termination of the study | 12. Premature termination of the study The Sponsor has the right to close this study (or, if applicable, individual segments thereof [e.g. treatment arms; dose steps; centers]) at any time, which may be due, but not limited to, the following reasons: - If risk–benefit ratio becomes unacceptable owing to, for example, -... | [] |
NCT02799602 | 13 | Ethical and legal aspects | 13. Ethical and legal aspects | [] |
NCT02799602 | 13.1 | Investigator(s) and other study personnel | 13.1 Investigator(s) and other study personnel
Sponsor's medical expert Name: PPD Address: Muellerstrasse 178 13353 Berlin, Germany Telephone no.: PPD
Co–ordinating investigators  All other study personnel not included in this section are identified in a separate personnel list (not part of th... | [
"Sponsor's medical expert",
"Co–ordinating investigators"
] |
NCT02799602 | 13.1.1 | Independent data monitoring committee | 13.1.1 Independent data monitoring committee A DMC will be instituted to ensure ongoing safety of study subjects with respect to a risk/benefit assessment during periodic data review meetings, review results from the planned interim analysis and provide a formal recommendation for continuation/termination of the study ... | [] |
NCT02799602 | 13.2 | Funding and financial disclosure | 13.2 Funding and financial disclosure
Funding This study will be funded by its Sponsor.
Financial disclosure Each Investigator (including principal and/or any sub–investigators) who is directly involved in the treatment or evaluation of research subjects has to provide a financial disclosure according to all applicab... | [
"Funding",
"Financial disclosure"
] |
NCT02799602 | 13.3 | Ethical and legal conduct of the study | 13.3 Ethical and legal conduct of the study The procedures set out in this protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the Sponsor and Investigator abide by GCP guidelines and the guiding principles detailed in the Declaration of Helsinki. The study will... | [] |
NCT02799602 | 13.4 | Subject information and consent | 13.4 Subject information and consent All relevant information on the study will be summarized in an integrated subject information sheet and ICF provided by the Sponsor or the study center. A sample subject information and ICF is provided as a document separate to this protocol. Based on this subject information sheet,... | [] |
NCT02799602 | 13.5 | Publication policy and use of data | 13.5 Publication policy and use of data The Sponsor has made the information regarding the study protocol publicly available on the internet at www.clinicaltrials.gov.  26 MAY 2020 Version 5.0 Page: 91 of 108 All data and results and all intellectual property rights in the data and results deriv... | [] |
NCT02799602 | 13.6 | Compensation for health damage of subjects / insurance | 13.6 Compensation for health damage of subjects / insurance The Sponsor maintains clinical trial insurance coverage for this study in accordance with the laws and regulations of the country in which the study is performed. | [] |
NCT02799602 | 13.7 | Confidentiality | 13.7 Confidentiality All records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. Subject names will not be supplied to the Sponsor. Only the subject number will be recorded in the CRF, and if the subject name ... | [] |
NCT02799602 | 14 | Reference list | 14. Reference list - 1. Ferlay J, Steliarova–Foucher E, Lortet–Tieulent J, Rosso S, Coebergh JW, Comber H, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49(6):1374–403. - 2. Ferlay J, Parkin DM, Steliarova–Foucher E. Estimates of cancer incidence and mo... | [] |
NCT02799602 | 15 | Protocol amendments | 15. Protocol amendments | [] |
NCT02799602 | 15.1 | Amendment 2 | 15.1 Amendment 2 Amendment 2 is a global amendment dated 04 OCT 2016. | [] |
NCT02799602 | 15.1.1 | Overview of changes to the study | 15.1.1 Overview of changes to the study | [] |
NCT02799602 | 15.1.1.1 | Modification 1: New drug–drug interaction data available | 15.1.1.1 Modification 1: New drug–drug interaction data available It was clarified that interaction between ODM–201 and P–gp or BCRP are expected in vivo based on in vitro data and preliminary clinical study results. Text in the protocol was revised, to mention the preliminary results of a drug–drug interaction clinica... | [] |
NCT02799602 | 15.1.1.2 | Modification 2: Clarification of PK analysis | 15.1.1.2 Modification 2: Clarification of PK analysis Wording defining the patient population for the detailed PK analysis was revised and clarified throughout the protocol. Wording about docetaxel analysis for the sparse PK sampling in all randomized subjects was also revised and clarified throughout the protocol. Rat... | [] |
NCT02799602 | 15.1.1.3 | Modification 3: Addition of non–protein–bound (free) testosterone analysis | 15.1.1.3 Modification 3: Addition of non–protein–bound (free) testosterone analysis Wording throughout the protocol was revised to add the non–protein–bound (free) testosterone analysis in a subset of 300 subjects. Rationale: Low testosterone levels are expected in subjects during ADT treatment, therefore the sex hormo... | [] |
NCT02799602 | 15.1.1.4 | Modification 4: Administrative changes | 15.1.1.4 Modification 4: Administrative changes Sponsor's study medical expert was updated due to a change in sponsor's personnel. The contact information was also added to Section [13.1](#page-87-0) as per template. The contact details of Co-ordinating investigators were also added. Sections affected by this modificat... | [] |
NCT02799602 | 15.1.1.5 | Modification 5: Other clarifications and corrections | 15.1.1.5 Modification 5: Other clarifications and corrections - Scheme of study periods was updated: "treatment with study drug" was changed to "treatment period" to clarify that also docetaxel is given during treatment period. - Subheading "Further safety" was added as per template, content was not changed. Sections a... | [] |
NCT02799602 | 15.1.2 | Changes to the protocol text | 15.1.2 Changes to the protocol text Changes to the protocol text done in Amendment 2 are provided in Section 15.1.2 of Amendment 2. | [] |
NCT02799602 | 15.2 | Amendment 5 | 15.2 Amendment 5 Amendment 5 is a global amendment dated 12 FEB 2018. | [] |
NCT02799602 | 15.2.1 | Overview of changes to the study | 15.2.1 Overview of changes to the study | [] |
NCT02799602 | 15.2.1.1 | Modification 1: New drug-drug interaction data available | 15.2.1.1 Modification 1: New drug-drug interaction data available Text was modified to include the results of drug–drug interaction clinical study, and to provide the Investigators with guidance how to manage relevant concomitant medications: Concomitant treatment with strong and moderate CYP3A4 inducers should be avoi... | [] |
NCT02799602 | 15.2.1.2 | Modification 2: Modification of the dosing language | 15.2.1.2 Modification 2: Modification of the dosing language The wording for the study drug dose to be administered was modified and harmonized throughout the protocol: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg. A guidance text in the event of a missed dose was adde... | [] |
NCT02799602 | 15.2.1.3 | Modification 3: Clarification of docetaxel dosage and administration | 15.2.1.3 Modification 3: Clarification of docetaxel dosage and administration The possibility to administer docetaxel as per local practice (if different from the regimen described in the summary of product characteristics) was removed from the protocol, and also the guidance to refer to the local prescribing informati... | [] |
NCT02799602 | 15.2.1.4 | Modification 4: Guidance on laboratory tests before each docetaxel cycle | 15.2.1.4 Modification 4: Guidance on laboratory tests before each docetaxel cycle The list of laboratory assessments that should be performed before each docetaxel cycle was added to the protocol. It was also clarified that docetaxel can only be infused after routine hematology and biochemistry laboratory tests have be... | [] |
NCT02799602 | 15.2.1.5 | Modification 5: Clarification related to soft tissue/visceral lesions | 15.2.1.5 Modification 5: Clarification related to soft tissue/visceral lesions It was clarified that the evaluation of soft tissue and visceral lesions is done with the same radiological methods and assessed by RECIST criteria. Rationale: The change was done for clarity and for consistency throughout the protocol. Sect... | [] |
NCT02799602 | 15.2.1.6 | Modification 6: Time windows for randomization and Visit 1 | 15.2.1.6 Modification 6: Time windows for randomization and Visit 1 Protocol was modified to state that randomization must occur within 28 days from ICF signature and that the patient will be randomized at the end of the screening period. In addition, the time window for Day 1 (Visit 1) procedures was adjusted to clari... | [] |
NCT02799602 | 15.2.1.7 | Modification 7: Switch of ADT to LHRH agonist prohibited | 15.2.1.7 Modification 7: Switch of ADT to LHRH agonist prohibited ADT switch to LHRH agonist was added to the list of prohibited concomitant medications and treatments. It was also clarified that ADT switch to an antagonist is allowed during study treatment. Rationale: Switch of ADT to LHRH agonist may cause flare reac... | [] |
NCT02799602 | 15.2.1.8 | Modification 8: Collection of whole blood sample for pharmacogenetics test allowed at other visits if missed at Visit 1 | 15.2.1.8 Modification 8: Collection of whole blood sample for pharmacogenetics test allowed at other visits if missed at Visit 1 A whole blood sample for pharmacogenetic testing will be collected preferably at Visit 1 from subjects who have signed pharmacogenetic consent. However, the protocol was modified to allow the... | [] |
NCT02799602 | 15.2.1.9 | Modification 9: Unblinding in non-emergency situations not permitted | 15.2.1.9 Modification 9: Unblinding in non-emergency situations not permitted It was clarified that progressive disease does not routinely constitute an emergency situation, therefore unblinding the label only for subsequent treatment decision is not allowed. Rationale: The modification was done to clarify that unblind... | [] |
NCT02799602 | 15.2.1.10 | Modification 10: Clarification of PK sampling | 15.2.1.10 Modification 10: Clarification of PK sampling It was clarified that two additional blood samples for sparse PK analysis can be taken from docetaxel cycle 1 onwards from patients who do not belong to the dense PK subset. Rationale: To provide clear instructions to the sites regarding collection of blood sample... | [] |
NCT02799602 | 15.2.1.11 | Modification 11: Clarification of laboratory safety assessments | 15.2.1.11 Modification 11: Clarification of laboratory safety assessments It was clarified in the protocol text that PSA at screening can be taken within 28 days before randomization. Rationale: To provide clear instructions about timing of the safety laboratory assessments in the screening period. Section affected by ... | [] |
NCT02799602 | 15.2.1.12 | Modification 12: Nomenclature change | 15.2.1.12 Modification 12: Nomenclature change With the approval of the INN darolutamide, the Orion drug nomenclature (ODM-201) was replaced with darolutamide throughout the protocol. In addition, the Orion codes for darolutamide diastereomers and metabolite were replaced with trivial names in the entire document as sh... | [] |
NCT02799602 | 15.2.1.13 | Modification 13: Personnel change | 15.2.1.13 Modification 13: Personnel change The sponsor's medically responsible person was changed as a result of personnel change. Section affected by this modification: Signature of the sponsor's medically responsible person | [] |
NCT02799602 | 15.2.1.14 | Modification 14: Other clarifications and corrections | 15.2.1.14 Modification 14: Other clarifications and corrections - A typo was corrected in Section [9.7.1.4](#page-75-2) (incomplete sentence). - The abbreviation for AUC(0-x) was corrected in the list of abbreviations. - The word "approval" was changed to "agreement" in Section [9.2.1](#page-52-0) to clarify that the B... | [] |
NCT02799602 | 15.2.2 | Changes to the protocol text | 15.2.2 Changes to the protocol text Changes to the protocol text done in Amendment 5 are provided in a separate track changes version.  26 MAY 2020 Version 5.0 Page: 100 of 108 | [] |
NCT02799602 | 15.3 | Amendment 6 | 15.3 Amendment 6 Amendment 6 is a global amendment dated 10 DEC 2019. | [] |
NCT02799602 | 15.3.1 | Overview of changes to the study | 15.3.1 Overview of changes to the study | Section(s) | Description of change | Rationale | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02799602 | 15.3.2 | Changes to the protocol text | 15.3.2 Changes to the protocol text Changes to the protocol text done in Amendment 6 are provided in a separate track changes version.  26 MAY 2020 Version 5.0 Page: 103 of 108 | [] |
NCT02799602 | 15.4 | Amendment 7 | 15.4 Amendment 7 Amendment 7 is a global amendment dated 26 MAY 2020. 15.4.1 Overview of changes to the study | Section(s) | Description of change | Rationale | |--------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02799602 | 15.4.2 | Changes to the protocol text | 15.4.2 Changes to the protocol text Changes to the protocol text done in Amendment 7 are provided in a separate track changes version.  26 MAY 2020 Version 5.0 Page: 104 of 108 | [] |
NCT02799602 | 16 | Appendices | 16. Appendices | [] |
NCT02799602 | 16.1 | Eastern Cooperative Oncology Group performance status | 16.1 Eastern Cooperative Oncology Group performance status | Grade | Description | |-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | 0 | Fully active, able to carry on all pre–disease performance wit... | [] |
NCT02799602 | 16.2 | National Cancer Institute–Common Terminology Criteria for Adverse Events | 16.2 National Cancer Institute–Common Terminology Criteria for Adverse Events This study will utilize the NCI–CTC for Adverse Events Version 4.03 for toxicity and serious AEs reporting. A copy of the CTC Version 4.03 can be downloaded in PDF form from http://evs.nci.hin.gov/ftp1/CTCAE/About.html. All appropriate treatm... | [] |
NCT02799602 | 16.3 | NCCN–FACT FPSI–17 | 16.3 NCCN–FACT FPSI–17 Below is a list of statements that other people with your illness have said are important. Please circle or mark one number per line to indicate your response as it applies to the past 7 days. | | | | Not atall | Alittlebit | Somewhat | Quitea bit | Verymuch | |-------------|-------|-------------... | [] |
NCT02799602 | 16.4 | BPI–SF | 16.4 BPI–SF  26 MAY 2020 Version 5.0 Page: 107 of 108  26 MAY 2020 Version 5.0 Page: 108 of 108 | [] |
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