protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03907241 | 4.3.2 | Patient Replacement Policy | 4.3.2 Patient Replacement Policy Patients withdrawn from the study for any reason will not be replaced. | [] |
NCT03907241 | 4.4 | Assignment of Patients to Treatment Groups | 4.4 Assignment of Patients to Treatment Groups
SCGAM-01 patients only: In the main study SCGAM-01, patients were recruited into four age strata: ≥2 years and <5 years, ≥5 years and <12 years, ≥12 years and <16 years, and ≥16 and ≤75 years. In the present extension study, they will remain in the strata that they were i... | [
"SCGAM-01 patients only:",
"De novo patients only:"
] |
NCT03907241 | 4.5 | Relevant Protocol Deviations | 4.5 Relevant Protocol Deviations In the case of any major deviation from this study protocol, the Investigator and Octapharma will decide on the further participation of the patient in this study, after having discussed all relevant aspects. A list of all included patients with all deviations from the intended study pr... | [] |
NCT03907241 | 4.6 | Subsequent Therapy | 4.6 Subsequent Therapy If a patient decides to withdraw from the study or is withdrawn by the Investigator, he/she may be switched back to the treatment that he/she received before participation in the study or to another commercially available IVIG or SCIG. | [] |
NCT03907241 | 5 | INVESTIGATIONAL MEDICINAL PRODUCT(S) | 5 INVESTIGATIONAL MEDICINAL PRODUCT(S) | [] |
NCT03907241 | 5.1 | Characterisation of Investigational Product(s) | 5.1 Characterisation of Investigational Product(s) Name of Medicinal Product: Octanorm Active ingredient of octanorm: Human normal immunoglobulin Table 1 Biochemical Characteristics of octanorm | Parameter | | |-----------------------------------------------|-------------------------------------| | ≥96% is human IgG)To... | [] |
NCT03907241 | 5.2 | Packaging and Labelling | 5.2 Packaging and Labelling Octanorm is delivered in glass vials. The label on the octanorm vial will be in the respective language(s) of the country and will be in accordance with local regulations. Label terminology may vary according to local regulations, and country-specific remarks will be added as needed. Sample ... | [
"Master Label Canada",
"Master Label USA"
] |
NCT03907241 | 5.3 | Conditions for Storage and Use | 5.3 Conditions for Storage and Use Octanorm must be stored and transported light-protected at 36 °F to 46 °F (2 °C to +8 °C) and must not be frozen. Octanorm must not be used after its expiration date. Authorised personnel at the individual study centres will ensure that the investigational product is stored in appropr... | [] |
NCT03907241 | 5.4 | Dose and Dosing Schedule | 5.4 Dose and Dosing Schedule Octanorm has to be administered subcutaneously every week (±2 days). A minimum interval of 4 days must be observed between two single subcutaneous infusions. If, during the study, the body weight changes by >5%, the dose is to be adjusted to keep the dose constant on a 'mg per kg body weigh... | [
"SCGAM-01 patients only:",
"De novo patients only:"
] |
NCT03907241 | 5.5 | Preparation and Method of Administration | 5.5 Preparation and Method of Administration Vials of octanorm must be allowed to warm to room or body temperature before infusion. Thereafter, octanorm should be infused subcutaneously using a syringe driver for precise infusion rates and standard infusion materials provided to the patients by the site. The correct am... | [
"Infusion sites:",
"Volume:"
] |
NCT03907241 | 5.6 | Blinding, Emergency Envelopes and Breaking the Study Blind | 5.6 Blinding, Emergency Envelopes and Breaking the Study Blind Not applicable for this open-label study. | [] |
NCT03907241 | 5.7 | Treatment Compliance | 5.7 Treatment Compliance | [] |
NCT03907241 | 5.7.1 | Drug Dispensing and Accountability | 5.7.1 Drug Dispensing and Accountability All IMP provided to the site will be accounted for. This includes IMP received at the site, dispensed to patients, and IMP returned unused by the subject/patient. Sponsor or designee will deliver octanorm to the participating investigators. Investigator will keep current drug in... | [] |
NCT03907241 | 5.7.2 | Assessment of Treatment Compliance | 5.7.2 Assessment of Treatment Compliance Patients will receive infusions at the study site and at home (administered at home by the patient or his/her relative or carer). Infusion details will be documented together with the batch number(s) in the eCRF. Throughout the study, patients will be asked to document on a Diar... | [] |
NCT03907241 | 5.8 | Rescue Medication/ Risk Management | 5.8 Rescue Medication/ Risk Management In the event of a (serious) AE, infection(s), treatment failure and or if the patient does not tolerate the treatment, the Investigator will direct the patient for an immediate unscheduled visit to ensure their safety and wellbeing. If a patient decides to withdraw from the study ... | [] |
NCT03907241 | 6 | STUDY CONDUCT | 6 STUDY CONDUCT | [] |
NCT03907241 | 6.1 | Observations by Visit | 6.1 Observations by Visit | [] |
NCT03907241 | 6.1.1 | Screening Visit | 6.1.1 Screening Visit
SCGAM-01 patients only (United States, Canada): The Screening (First) Visit will in most cases be the same as the last study visit (Termination Visit scheduled in week 65, the End-of-study visit) of the main study SCGAM-01 (since most patients will migrate directly from the main study SCGAM-01 to... | [
"SCGAM-01 patients only (United States, Canada):"
] |
NCT03907241 | 6.1.2 | Treatment and Assessment Visits; Termination Visit | 6.1.2 Treatment and Assessment Visits; Termination Visit
De novo patients only (Canada): One week after Screening Visit, all patients will attend the site for Visit N. This will be the first Treatment Visit with octanorm (without laboratory tests). On study visit days, administration will be performed on site; otherwi... | [
"De novo patients only (Canada):",
"During or after IMP administration",
"Termination Visit:",
"Unscheduled visits:"
] |
NCT03907241 | 6.1.3 | Interpretation of Time Windows in This Study | 6.1.3 Interpretation of Time Windows in This Study For this study the following time windows apply: | Time point | Time stated | Tolerance | |--------------------------------------------|-------------|-----------| | On site visit N(de novo patients only) | Week 2 | ± 2 days | | On site Visits 2, 3, 4, 5, 6, 7, 8, 9, 10... | [] |
NCT03907241 | 6.2 | Duration of Study | 6.2 Duration of Study | [] |
NCT03907241 | 6.2.1 | Planned Duration for an Individual Patient | 6.2.1 Planned Duration for an Individual Patient USA: The maximum total duration of the study for an individual patient will be approximately 2.5 years. Canada: The individual treatment duration in Canada will be approximately 12 months. | [] |
NCT03907241 | 6.2.2 | Planned Duration for the Study as a Whole | 6.2.2 Planned Duration for the Study as a Whole USA: The study started enrolling in the second quarter of 2016. Completion of the study by the last patient is expected for approximately fourth quarter of 2018. The total study duration will be approximately 2.5 years. Canada: The study is planned to start enrolling in t... | [] |
NCT03907241 | 6.2.3 | Premature Termination of the Study | 6.2.3 Premature Termination of the Study Both the responsible Investigators and the Sponsor reserve the right to terminate the study at any time. Should this be necessary, the procedures will be arranged on an individual study basis after review and consultation by both parties. In terminating the study, the Sponsor an... | [
"Study Centre"
] |
NCT03907241 | 7 | ASSESSMENTS AND METHODS | 7 ASSESSMENTS AND METHODS | [] |
NCT03907241 | 7.1 | Background / Baseline Information | 7.1 Background / Baseline Information The following general or background assessments will be performed during the study at predefined time points: Demographic data: All demographic data (age, weight, height, calculated body mass index, ethnic origin, ABO Rhesus blood type) will be taken over from the main study SCGAM-... | [] |
NCT03907241 | 7.2 | Efficacy Assessments | 7.2 Efficacy Assessments To study the effectiveness of octanorm in the prevention of infections, the following measurements will be recorded throughout the study: • Number of episodes of SBI, per person-year on treatment, along with type and severity of infection, and time to resolution (primary endpoint). - Number of ... | [
"Table 2 Diagnostic Criteria for Serious Infection Types",
"Infection: Bacteraemia/sepsis a",
"Infection: Bacterial Meningitis",
"Infection: Osteomyelitis/Septic Arthritis",
"Infection: Bacterial Pneumonia d",
"Infection: Visceral Abscess",
"Notes to [Table 2](#page-33-0):"
] |
NCT03907241 | 7.3 | Safety Assessments | 7.3 Safety Assessments Any of the following drug safety information shall be collected: Adverse events (AEs) and serious adverse events (SAEs) temporally associated with administration of IMP. | [] |
NCT03907241 | 7.3.1 | Adverse Events | 7.3.1 Adverse Events | [] |
NCT03907241 | 7.3.1.1 | Definitions | 7.3.1.1 Definitions Adverse event (AE): An AE is any untoward medical occurrence in a study patient receiving an IMP and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease ... | [] |
NCT03907241 | 7.3.1.2 | Collection | 7.3.1.2 Collection The condition of the patient will be monitored throughout the study. At each visit, whether scheduled or unscheduled, AEs will be elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" For minor patients not understanding th... | [] |
NCT03907241 | 7.3.1.3 | Severity | 7.3.1.3 Severity The intensity/severity of AEs will be graded as follows: - mild: an AE, usually transient, which causes discomfort but does not interfere with the patient's routine activities; - moderate: an AE which is sufficiently discomforting to interfere with the patient's routine activities; - severe: an AE whic... | [] |
NCT03907241 | 7.3.1.4 | Causality | 7.3.1.4 Causality The relationship of AEs to the administered IMP will be assessed by the Investigator: - Probable: reports including good reasons and sufficient documentation to assume a causal relationship, in the sense of plausible, conceivable, likely, but not necessarily highly probable. A reaction that follows a ... | [
"Classification of ADRs:"
] |
NCT03907241 | 7.3.1.5 | Outcome | 7.3.1.5 Outcome The outcome of an AE has to be classified as follows: - recovered, resolved - recovering, resolving - not recovered, not resolved - recovered, resolved with sequelae - fatal - unknown NOTE: A patient's death per se is not an event, but an outcome. The event which resulted into a patient's death must be ... | [] |
NCT03907241 | 7.3.1.6 | Action(s) taken | 7.3.1.6 Action(s) taken AEs requiring action or therapy must be treated with recognised standards of medical care to protect the health and well-being of the patient. Appropriate resuscitation equipment and medicines must be available to ensure the best possible treatment in an emergency situation. The action taken by ... | [
"a) in general",
"b) on IMP"
] |
NCT03907241 | 7.3.2 | Local Reactions | 7.3.2 Local Reactions Local injection-site reactions are to be assessed by both patients and investigators. Patients have to grade the overall perception of local reactions in their Diaries after each infusion using a 4-point rating scale: 0=none, 1=mild, 2=moderate, 3=severe. Investigators have to evaluate local react... | [] |
NCT03907241 | 7.3.3 | Serious Adverse Events | 7.3.3 Serious Adverse Events A serious AE (SAE) is any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires hospitalisation or prolongation of existing hospitalisation, - results in persistent or significant disability/incapacity, - is a congenital anomaly/birth defect, - ... | [
"SAE reporting timelines"
] |
NCT03907241 | 7.3.4 | Laboratory Safety Tests | 7.3.4 Laboratory Safety Tests For children the trial-related blood loss (including any losses in the manoeuvre) should not exceed 3% of the total blood volume during a period of 4 weeks and should not exceed 1% at any single draw. The total volume of blood is estimated at 80 mL/kg body weight. The following laboratory ... | [] |
NCT03907241 | 7.3.5 | Viral Safety Tests | 7.3.5 Viral Safety Tests At the Screening Visit, viral markers will be taken before the octanorm infusion, and will be tested at the local laboratory according to the site's standard procedures. For patients positive in Hepatitis A virus at screening, follow-up samples may be omitted. Further viral marker samples will ... | [] |
NCT03907241 | 7.3.6 | Vital Signs | 7.3.6 Vital Signs To evaluate short-term tolerance, monitoring of vital signs including blood pressure, body temperature, pulse and respiratory rate will be performed at visits taking place at the clinic/study site; the Screening Visit, then at all subsequent study visits, and finally at the Termination Visit (irrespec... | [] |
NCT03907241 | 7.3.7 | Physical Examination | 7.3.7 Physical Examination A general physical examination will be performed at the Screening Visit according to routine procedures and will be as comprehensive as necessary to detect relevant abnormalities. If any findings are abnormal (SCGAM-01 patients: only the findings that newly occurred since end of the SCGAM-01 ... | [] |
NCT03907241 | 7.3.8 | Other Relevant Safety Information | 7.3.8 Other Relevant Safety Information
Post study related safety reports Any SAE which occurs up to four weeks after the completion of the study should be reported by the Investigator to the sponsor if the investigator becomes aware of it. Proactive monitoring for post-study SAEs is not required. If a post study SAE ... | [
"Post study related safety reports",
"Pregnancies",
"Overdose, interaction and medication error",
"Drug overdose",
"Interaction",
"Medication error"
] |
NCT03907241 | 7.4 | Other Assessments | 7.4 Other Assessments | [] |
NCT03907241 | 7.4.1 | Drug Concentration Measurements | 7.4.1 Drug Concentration Measurements Samples for total IgG trough levels measurements will be taken at the Screening Visit, before any infusion given at the study site and at the (early) Termination Visit; these samples will analysed at the local laboratory. | [] |
NCT03907241 | 7.4.2 | Quality of Life Assessment | 7.4.2 Quality of Life Assessment QoL assessments will be made using the Child Health Questionnaire-Parent Form (CHQ-PF50) from parent or guardian of patients <14 years of age and the SF-36 Health Survey in patients ≥14 years of age. The QoL assessments will take place at the Screening Visit, at Week 60 (Visit 6), and a... | [] |
NCT03907241 | 7.5 | Appropriateness of Measurements | 7.5 Appropriateness of Measurements Safety will be monitored by standard assessment. The therapeutic efficacy, defined as the prevention of SBI, is a very important clinical aspect of any IgG replacement therapy and best characterises benefit to the patient. Determination of the pre-next-dose trough level of IgG is a s... | [] |
NCT03907241 | 8 | DATA HANDLING AND RECORD KEEPING | 8 DATA HANDLING AND RECORD KEEPING To ensure that data in the CRFs are accurate and complete and in accordance with source records, source data verification will be performed in accordance with Octapharma standards. The extent of source data verification will be defined in detail in the monitoring manual. | [] |
NCT03907241 | 8.1 | Documentation of Data | 8.1 Documentation of Data | [] |
NCT03907241 | 8.1.1 | Source Data and Records | 8.1.1 Source Data and Records Source data are defined as all of the information related to clinical findings, observations, or other activities in the study, written down in original records or certified copies of original records. The investigator will maintain adequate source records (e.g., case histories or subject/... | [] |
NCT03907241 | 8.1.2 | Electronic Case Report Forms (eCRF) | 8.1.2 Electronic Case Report Forms (eCRF) For each patient enrolled, an eCRF will be completed within the electronic data capture (EDC) system and approved by the Investigator or an authorised sub-investigator. Study-site staff (e.g. research nurse) will be responsible for entering patient data into the validated EDC s... | [] |
NCT03907241 | 8.1.3 | Changes to Case Report Form Data | 8.1.3 Changes to Case Report Form Data Monitors will perform source data verification (SDV) as defined for the study. Errors occurring on the EDC system can only be corrected by the investigator(s) or authorised site personnel. An audit trail documents all changes to the data over the entire study period. If data is ch... | [] |
NCT03907241 | 8.1.4 | Handling of Missing Data | 8.1.4 Handling of Missing Data In general, missing data will not be imputed: calculations pertaining to person-year computations will be based on observed values only. Only in case of missing body weight, the last available weight measurement will be used for calculating the dose per kg bodyweight (last observation car... | [] |
NCT03907241 | 8.2 | Information of Investigators | 8.2 Information of Investigators An Investigator's Brochure will be handed out to the Investigator before the start of the study, unless the investigator is already in possession of the current Investigator's Brochure. This brochure contains all information in the Sponsor's possession necessary for the Investigator to ... | [] |
NCT03907241 | 8.3 | Responsibilities | 8.3 Responsibilities The principal Investigator is accountable for the conduct of the clinical study. Responsibilities may be delegated to appropriately qualified persons. A "Delegation of Authority Log" will be filled in and signed by the Investigator. In accordance with this authority log study-site staff (e.g., sub-... | [] |
NCT03907241 | 8.4 | Investigator's Site File | 8.4 Investigator's Site File At each study site, the Investigator is responsible for maintaining all records to enable the conduct of the study to be fully documented. Essential documents as required by GCP guidelines and regulations (e.g., copies of the protocol, study approval letters, all original informed consent f... | [] |
NCT03907241 | 8.5 | Provision of Additional Information | 8.5 Provision of Additional Information On request, the Investigator will supply the Sponsor with additional data relating to the study, or copies of relevant source records, ensuring that the patient's confidentiality is maintained. This is particularly important when source data are illegible or when errors in data t... | [] |
NCT03907241 | 8.6 | Independent Data Monitoring Committee | 8.6 Independent Data Monitoring Committee The Sponsor will establish an IDMC. During the study, the IDMC will periodically review relevant data and will give advice on the continuation, modification or termination of the study (see Section [6.2.3\)](#page-31-3). A study-specific Charter will define in detail the compos... | [] |
NCT03907241 | 9 | STATISTICAL METHODS AND SAMPLE SIZE | 9 STATISTICAL METHODS AND SAMPLE SIZE The statistical analysis will be delegated under an agreement of transfer of responsibilities to an external CRO. All Octapharma procedures and policies have to be met by this CRO. Discrepancies or exceptions are to be approved by the Sponsor's Manager of Biometrics. | [] |
NCT03907241 | 9.1 | Determination of Sample Size | 9.1 Determination of Sample Size Approximately 45 patients are planned in total: - All the patients who complete the main study SCGAM-01 in the USA or in Canada and who are willing and eligible to continue study treatment will be included in the present extension study. At the time of preparation of this protocol is it... | [] |
NCT03907241 | 9.2 | Statistical Analysis | 9.2 Statistical Analysis No confirmatory statistical analysis will be performed; the results of this extension study will be presented at the descriptive level only. | [] |
NCT03907241 | 9.2.1 | Population for Analysis | 9.2.1 Population for Analysis The following populations will be considered for the statistical analysis: The safety analysis set consists of all patients who received at least part of one infusion of octanorm within this extension study. The full analysis set (FAS) is defined according to the intention-to-treat princip... | [] |
NCT03907241 | 9.2.2 | Efficacy Analysis Plan | 9.2.2 Efficacy Analysis Plan No confirmatory efficacy analysis will be performed. The rate of SBI per person-year (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) during the treatment period with octanorm will be presented as point estimates of the rate a... | [] |
NCT03907241 | 9.2.3 | Safety Analysis Plan | 9.2.3 Safety Analysis Plan The safety analysis will comprise descriptive statistics, tabulations and listings of all TEAEs, safety laboratory results, viral markers, vital signs and physical examination findings. | [] |
NCT03907241 | 9.2.3.1 | Adverse Events | 9.2.3.1 Adverse Events All reported AEs will be coded according to MedDRA. An AE is defined as treatment-emergent, if first onset or worsening is after start of the first infusion of octanorm. Only TEAEs are accounted for in the analysis. AEs that occur between informed consent and the start of the first infusion of oc... | [] |
NCT03907241 | 9.3 | Randomisation / Stratification / Code Release | 9.3 Randomisation / Stratification / Code Release There is no randomisation in this study. | [] |
NCT03907241 | 9.4 | Interim Analysis | 9.4 Interim Analysis No interim analysis is planned. | [] |
NCT03907241 | 10 | ETHICAL / REGULATORY, LEGAL AND ADMINISTRATIVE ASPECTS | 10 ETHICAL / REGULATORY, LEGAL AND ADMINISTRATIVE ASPECTS | [] |
NCT03907241 | 10.1 | Ethical / Regulatory Framework | 10.1 Ethical / Regulatory Framework This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Before submission of the study protocol to the IRB and Competent Authority, the study will be registered in ClinicalTrials.gov. The study protocol and any su... | [] |
NCT03907241 | 10.2 | Approval of Study Documents | 10.2 Approval of Study Documents The study protocol, a sample of the patient information and informed consent form, and further requested information will be submitted to the appropriate IRB and the competent Authority. The study approval letter must be available before any patient is exposed to a study-related procedu... | [] |
NCT03907241 | 10.3 | Patient Information and Informed Consent | 10.3 Patient Information and Informed Consent The Investigator will obtain freely given written consent from each patient after an appropriate explanation of the aims, methods, anticipated benefits, potential hazards and any other aspect of the study which is relevant to the patient's decision to participate. The infor... | [] |
NCT03907241 | 10.4 | Protocol Amendments | 10.4 Protocol Amendments Any prospective change to the protocol will be agreed between the Investigator (Coordinating Investigator in multicentre studies) and the Sponsor before its implementation. Any such amendments will be submitted to the IRB and/or Competent Authority responsible as required by applicable regulati... | [] |
NCT03907241 | 10.5 | Confidentiality of Patients' Data | 10.5 Confidentiality of Patients' Data The Investigator will ensure that the patient's confidentiality will be preserved. On eCRFs or any other documents submitted to the Sponsor, the patients will not be identified by their names, but by an identification code, consisting of a centre number and a patient number. Docum... | [] |
NCT03907241 | 11 | QUALITY CONTROL AND QUALITY ASSURANCE | 11 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03907241 | 11.1 | Periodic Monitoring | 11.1 Periodic Monitoring The monitor will contact and visit the investigator periodically to review all study-related source data/records, verify the adherence to the protocol and the completeness, correctness and accuracy of all CRF entries compared to source data. The investigator will co-operate with the monitor to ... | [] |
NCT03907241 | 11.2 | Audit and Inspection | 11.2 Audit and Inspection The Investigator will make all study-related source data and records available to a qualified quality assurance auditor mandated by the Sponsor, or to IRB / Regulatory Authority inspectors, after reasonable notice. The main purposes of an audit or inspection are to confirm that the rights and ... | [] |
NCT03907241 | 12 | REPORTING AND PUBLICATION | 12 REPORTING AND PUBLICATION | [] |
NCT03907241 | 12.1 | Clinical Study Report | 12.1 Clinical Study Report The Sponsor will prepare a clinical study report (in accordance with relevant guidelines and Octapharma Standard Operating Procedures) timely after the completion of the study. The Coordinating Investigator will approve the final study report after review. | [] |
NCT03907241 | 12.2 | Publication Policy | 12.2 Publication Policy The results of this study may be published or presented at scientific meetings. If this is envisaged by an Investigator, the Investigator agrees to inform the Sponsor and to submit all manuscripts or abstracts to the Sponsor before submission to an editorial board or scientific review committee.... | [] |
NCT03907241 | 13 | LIABILITIES AND INSURANCE | 13 LIABILITIES AND INSURANCE To cover any damage or injury occurring to a patient in association with the investigational medicinal product or the participation in the study, the Sponsor will contract insurance in accordance with local regulations. All participating investigators are responsible for dispensing the IMP ... | [] |
NCT03907241 | 14 | REFERENCES | 14 REFERENCES - 1. Berger M: Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal dose. Current opinion in allergy and clinical immunology 2011;11:532-538. - 2. Berger M, Jolles S, Orange JS, et al: Bioavailability of IgG Administered b... | [] |
NCT03907969 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY The structure of the protocol will follow a modular design. Sections 1 to 9, 16 and 17 of the protocol contain information mainly related to the Core Module and the overall study. Sections 10 to 16 of the protocol contain additional information specific to Combination Module 1. Further details on stu... | [] |
NCT03907969 | 1.1 | Schedule of Assessments – Core Module | 1.1 Schedule of Assessments – Core Module The SoA for Combination Module 1 can be found in Section 10.1. Table 1 Schedule of assessments – Core Module | | Screening | | Single Dose | | | Multiple Dose | | | | | | | | | IP | 28-day FUAfter IPDisc | Details inSection | |---------------------------------------------------... | [] |
NCT03907969 | 1.2 | Synopsis | 1.2 Synopsis
Principal Investigator: Dr Timothy Yap 1515 Holcombe Boulevard, Unit 0455 Houston, Texas 77030 United States
Protocol Title: A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination with eithe... | [
"Principal Investigator:",
"Protocol Title:",
"Rationale:",
"Study Design:",
"Main Objectives:",
"Study Period:",
"Number of Patients:",
"Treatments and Treatment Duration:"
] |
NCT03907969 | 1.3 | Schema | 1.3 Schema The general study design is shown in Figure 1. Figure 1 Study design  Lipo.dox=pegylated liposomal doxorubicin. | [] |
NCT03907969 | 2 | INTRODUCTION | 2 INTRODUCTION Study D9170C00001 is a Phase I/IIa, open-label, multi-centre, study of AZD7648 administered orally, either as monotherapy, or in combination with either cytotoxic chemotherapies or novel anti-cancer agents to patients with advanced malignancies. The modular design allows the evaluation of the safety, tol... | [] |
NCT03907969 | 2.1 | Study rationale | 2.1 Study rationale  | [] |
NCT03907969 | 2.2 | Background | 2.2 Background DNA damage events occur frequently in any living cell and various mechanisms have evolved to deal with them. Different forms of DNA damage trigger responses by different repair mechanisms and signalling pathways (Figure 2). Among DNA damage lesions, DSBs are the most cytotoxic. They induce cell cycle arr... | [] |
NCT03907969 | 2.3 | Benefit/risk assessment | 2.3 Benefit/risk assessment The Core Module of the study is a first time in human (FTIH) Phase I/IIa dose escalation study with the DNA-PK inhibitor AZD7648. Detailed information about the known and expected benefits and risks of AZD7648 may be found in the IB. The study design aims to minimise potential risks and alth... | [] |
NCT03907969 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS Table 2 Study objectives | Primary objective: | Endpoint/Variable: | | | | | |----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--|... | [] |
NCT03907969 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT03907969 | 4.1 | Overall design | 4.1 Overall design This is a modular Phase I/IIa, open-label, multi-centre, study of AZD7648 administered orally, either as monotherapy, or in combination with either cytotoxic chemotherapies or novel anti-cancer agents to patients with advanced malignancies. The modular design allows for an escalation of the dose of A... | [] |
NCT03907969 | 4.1.1 | Modular protocol structure | 4.1.1 Modular protocol structure The structure of the protocol will follow a modular design. The initial module will be a Core Module relating to AZD7648 monotherapy. Additional combination modules may be added as described below, via a formal amendment, based on emerging supportive preclinical data and study rationale... | [
"List of Modules"
] |
NCT03907969 | 4.1.2 | Core module study design: AZD7648 monotherapy | 4.1.2 Core module study design: AZD7648 monotherapy This part of the study is dose escalation (Part A) of AZD7648 monotherapy, administered orally, in approximately 46 evaluable patients with advanced solid tumours. Further details of the study design for Combination Module 1 can be found in Section 12. The starting do... | [] |
NCT03907969 | 4.1.3 | Regulatory amendment for additional modules | 4.1.3 Regulatory amendment for additional modules To support amendment of the protocol for additional combination modules, AstraZeneca will provide a summary of all non-clinical and clinical data to support the proposed new combination and dosing schedule, this will include updating the following: - Study objectives - ... | [] |
NCT03907969 | 4.1.3.1 | Europe and Rest of World | 4.1.3.1 Europe and Rest of World AstraZeneca will provide a substantial amendment for review and approval. | [] |
NCT03907969 | 4.1.3.2 | United States of America | 4.1.3.2 United States of America AstraZeneca will provide an amendment to the Food and Drug Administration (FDA) 30 days in advance of planned enrolment in the cohort for any future combination. AstraZeneca will begin enrolment of patients into that cohort in the United States (US) no sooner than 30 days from the date ... | [] |
NCT03907969 | 4.1.4 | Study Conduct Mitigation During Study Disruptions Due to Cases of Civil Crisis, Natural Disaster, or Public Health Crisis | 4.1.4 Study Conduct Mitigation During Study Disruptions Due to Cases of Civil Crisis, Natural Disaster, or Public Health Crisis The guidance given below supersedes instructions provided elsewhere in this Clinical Study Protocol (CSP) and should be implemented only during cases of civil crisis, natural disaster, or publ... | [] |
NCT03907969 | 4.2 | Scientific rationale for study design | 4.2 Scientific rationale for study design   This FTIH study with AZD7648 will be conducted within the context of a modular protocol to evaluate the safety, tolerability, PK and anti-tumour activity of AZD7648 at increasing doses as a monotherapy (Core Module) and in combi... | [] |
NCT03907969 | 4.3 | Justification for dose | 4.3 Justification for dose A dose of mg/day is proposed as the starting dose in this FTIH Phase 1 study in patients with advanced cancer, including patients with solid tumours. This is based on international guidance for starting dose selection for agents in cancer patients (International Conference on Harmonisation [I... | [] |
NCT03907969 | 4.3.1 | Justification for the dose escalation doses | 4.3.1 Justification for the dose escalation doses The selection of the starting dose is based upon international guidance for an ICH S9 patient population, and is based on the HNSTD dose level. However, when considering proposed human starting dose margins to measured exposure in the dog study, there is a 23-fold margi... | [] |
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