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protocol_id stringclasses 263 values	section_number stringlengths 1 12	title stringlengths 1 1.88k	content stringlengths 0 866k	merged_titles listlengths 0 491
NCT02052778	8.2.4	Patient Instructions for Handling Study Drug	8.2.4. Patient Instructions for Handling Study Drug The patient must be instructed in the handling of TAS-120 as follows: - ! To only remove the amount of TAS-120 needed at the time of dosing. - ! Not to remove doses in advance of the next scheduled dosing. - ! To bring all used and unused blister packs to the site at ...	[]
NCT02052778	8.3	Drug Accountability	8.3. Drug Accountability In accordance with International Council for Harmonisation (ICH) and local regulatory requirements, the investigator and/or the person responsible for dispensing investigational drug must be able at all times to account for all investigational product provided to the site. The appropriate site ...	[]
NCT02052778	8.4	Blinding	8.4. Blinding This is an open-label study.	[]
NCT02052778	9	STUDY PROCEDURES	9. STUDY PROCEDURES The study assessments are described by procedure in the following sections. All information required by the protocol must be recorded. The study schedule must be followed; however, in unavoidable circumstances (e.g., holidays, weekends, etc.) a window of ± 3 days is allowable for study procedures as...	[]
NCT02052778	9.1	Pre-screening of Tumor Tissue Sample for FGFR2 Gene Fusions or other FGFR2 Rearrangements in Patients with iCCA (Phase 2 Only)	9.1. Pre-screening of Tumor Tissue Sample for FGFR2 Gene Fusions or other FGFR2 Rearrangements in Patients with iCCA (Phase 2 Only) Archived or fresh tumor tissue biopsy samples will be tested for FGFR2 gene fusions or other FGFR2 rearrangements prior to enrolling patients to the Phase 2 part of the study. Patients can...	[]
NCT02052778	9.2	Informed Consent	9.2. Informed Consent A signed and dated ICF will be obtained from the patient as required by the protocol before any main screening procedures are conducted. A signed copy of the ICF will be given to the patient. Multiple ICFs covering different procedures will be required based upon local requirements.	[]
NCT02052778	9.3	Medical History	9.3. Medical History A complete medical history will be obtained during Screening within 28 days prior to first TAS-120 administration on Day 1 of Cycle 1. Existing signs and symptoms will be obtained during screening (within 28 days prior to TAS-120 administration on Day 1 of Cycle 1), and reviewed on Day 1 of Cycle 1...	[]
NCT02052778	9.4	Physical Examination	9.4. Physical Examination A complete physical examination will be performed at the time points listed below. - ! Screening (within 28 days prior to TAS-120 administration on Day 1 of Cycle 1). - ! Within 24 hours prior to TAS-120 administration on Day 1 of each cycle. Note that procedures performed during the screening...	[]
NCT02052778	9.5	Height, Vital Signs, and Weight	9.5. Height, Vital Signs, and Weight The patient's height will be obtained only during Screening within 28 days prior to TAS-120 administration on Day 1 of Cycle 1. The patient's vital signs (blood pressure, heart rate, body temperature, and respiration rate) and body weight will be collected at the time points listed ...	[]
NCT02052778	9.6	Performance Status	9.6. Performance Status An ECOG Performance Status score (see Appendix C ECOG Performance Status) will be obtained at the following time points: - ! Screening (within 28 days prior to first TAS-120 administration on Day 1 of Cycle 1). - ! Within 24 hours prior to TAS-120 administration on Day 1 of each cycle. Note that...	[]
NCT02052778	9.7	Electrocardiogram	9.7. Electrocardiogram A 12-lead resting ECG will be performed at the following time points: - ! Screening (within 28 days prior to TAS-120 administration on Day 1 of Cycle 1). - ! Two hours (± 15 min) after TAS-120 dose on Day 1 of Cycle 1. - ! For all subsequent cycles starting with Cycle 2, ECG should be performed o...	[]
NCT02052778	9.8	Ophthalmological Examination	9.8. Ophthalmological Examination Ophthalmological examination will be performed at the following time points: - ! Screening within 28 days prior to TAS-120 administration on Day 1 of Cycle 1. - ! 4-6 weeks after starting treatment with TAS-120 - ! Any other time due to local requirements, physician judgement and/or sy...	[]
NCT02052778	9.9	Neurological Examination	9.9. Neurological Examination Neurological examination will be performed at the following time points for all patients: - ! Screening (within 28 days prior to TAS-120 administration on Day 1 of Cycle 1). - ! Any other time due to local requirements, physician judgement and/or symptoms or signs of mineral deposits. - ! ...	[]
NCT02052778	9.9.1	Neurological Examination as part of RANO Evaluation for Patients with Primary CNS Tumors	9.9.1. Neurological Examination as part of RANO Evaluation for Patients with Primary CNS Tumors For patients with primary CNS tumors, a complete neurological examination will include assessment of level of consciousness, mental status, speech, vision fundus (papilledema), cranial nerves III, IV, VI, cranial nerves othe...	[]
NCT02052778	9.10	Clinical Laboratory Evaluations	9.10. Clinical Laboratory Evaluations Blood samples for hematology, coagulation, and chemistry assessments will be collected and measured as described in Section 9.10.1 and Section 9.10.2, respectively. Laboratory assessments obtained prior to signing of the ICF may be used as screening laboratory values if they were o...	[]
NCT02052778	9.10.1	Hematology and Coagulation	9.10.1. Hematology and Coagulation Blood for hematology and coagulation assessments will be collected at the following time points and when clinically indicated: - ! Screening (within 7 days prior to first TAS-120 administration on Day 1 of Cycle 1). - ! Obtain within 24 hours before TAS-120 administration on Day 1 of ...	[]
NCT02052778	9.10.2	Chemistry	9.10.2. Chemistry Blood (serum or plasma) will be collected at the following time points for serum chemistry assessments: - ! Screening (within 28 days prior to first TAS-120 administration on Day 1 of Cycle 1). - ! Obtain within 24 hours before TAS-120 administration on Day 1 of each cycle, and anytime on Day 8 and Da...	[]
NCT02052778	9.10.3	Urinalysis	9.10.3. Urinalysis Urine samples for qualitative analysis ("urine dipstick") will be collected at the time points listed below: - ! Screening (within 28 days prior to first TAS-120 administration on Day 1 of Cycle 1). - ! Within 24 hours prior to TAS-120 administration on Day 1 of each cycle. Note that procedures perfo...	[]
NCT02052778	9.12	Pregnancy Test	9.12. Pregnancy Test For patients who are WOCBP, pregnancy testing by assessment of serum beta-human chorionic gonadotropin (∃-HCG) will be conducted: - ! At screening (28 days prior to the first administration of TAS-120); and - ! At end of treatment (+0-7 days). Serum or urine pregnancy test is also required: - ! Wit...	[]
NCT02052778	9.13	Pharmacokinetic Sample Collection	9.13. Pharmacokinetic Sample Collection	[]
NCT02052778	9.13.1	Optional Pharmacokinetic Sample Collection for Phase 1 Expansion	9.13.1. Optional Pharmacokinetic Sample Collection for Phase 1 Expansion For all patients in the Phase 1 Expansion, optional blood PK samples (a minimum of 1 mL) may be collected per the investigator's discretion in any patient at the following time points: prior to dosing (0 hour) and post-dose at 1, 2, 3, 4, 6, and 2...	[]
NCT02052778	9.13.2	Pharmacokinetic Blood Sample Collection for Phase 1 Expansion/Phase 2	9.13.2. Pharmacokinetic Blood Sample Collection for Phase 1 Expansion/Phase 2 During Phase 1 Expansion and Phase 2, blood samples of TAS-120 will be collected on Day 1 of Cycle 2 pre-dose, 1 h ± 30 min. and 3 h ± 30 min. post-dose to assess the plasma exposure at 20 mg QD. In addition, blood samples will be collected o...	[]
NCT02052778	9.14	ctDNA Analysis of FGF/FGFR Aberrations	9.14. ctDNA Analysis of FGF/FGFR Aberrations	[]
NCT02052778	9.14.1	ctDNA from Blood Sample for the Analysis of FGF/FGFR Aberrations	9.14.1. ctDNA from Blood Sample for the Analysis of FGF/FGFR Aberrations For the Phase 1 Expansion and Phase 2, a blood sample will be collected to assess FGF/FGFR aberrations in ctDNA at Screening within 28 days prior to the first TAS-120 administration on Day 1 of Cycle 1 (required) and at the EOT visit (optional). A...	[]
NCT02052778	9.15	Prior and Concomitant Medications and Therapies	9.15. Prior and Concomitant Medications and Therapies All therapies and medications, prescription and over-the-counter, will be collected from the time the main study ICF is signed through the 30-day safety follow-up visit, including any medication used to treat AEs or SAEs during the 30-day follow-up period. Use of co...	[]
NCT02052778	9.16	Adverse Event Assessment	9.16. Adverse Event Assessment Patients will be monitored for any untoward medical events (AEs or SAEs) from the time the main study ICF is signed through 30 days after last dose of TAS-120 or until the start of new antitumor therapy, whichever is earlier. For the Phase 2 part of the study, any AEs or SAEs that occur a...	[]
NCT02052778	9.17	Tumor Assessments/Scans	9.17. Tumor Assessments/Scans	[]
NCT02052778	9.17.1	Tumor Assessment for Advanced Solid Tumors	9.17.1. Tumor Assessment for Advanced Solid Tumors Tumor assessments/imaging studies of the chest, abdomen, and pelvis (as clinically indicated) must be obtained at each time point listed below for all patients with solid tumors. - ! Screening within 28 days prior to Day 1 of Cycle 1. Computed tomography scans obtained...	[]
NCT02052778	9.17.2	Tumor Assessment for Brain Tumors	9.17.2. Tumor Assessment for Brain Tumors Patients will be evaluated for response by Gd-MRI. All Gd-MRIs (standard brain tumor MRI including both precontrast and postcontrast images using a Gadolinium (Gd) chelate as the contrast agent) should be performed when the patient is on a stable dose of steroids for at least 7...	[]
NCT02052778	9.18	Patient-Reported Outcomes	9.18. Patient-Reported Outcomes Two Patient-Reported Outcome (PRO) instruments, EuroQol-5D measure of health-related quality of life (EQ-5D) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be used in the Phase 2 part of the study. EQ-5D is a standard...	[]
NCT02052778	9.19	End-of-treatment Visit	9.19. End-of-treatment Visit An end-of-treatment (EOT) visit is required for all living patients who discontinue treatment. The EOT visit must be performed 0-7 days after the decision is made to discontinue study treatment (for patients who discontinue at a planned study visit, that visit may be considered the EOT visi...	[]
NCT02052778	9.20	30-Day Safety Follow-up	9.20. 30-Day Safety Follow-up A safety follow-up visit will be conducted 30 days after the last dose of TAS-120. If the patient starts new anticancer therapy within 30 days of the last dose of TAS-120, the 30-day safety follow-up visit should be performed prior to the start of new anticancer therapy within the 30-day w...	[]
NCT02052778	9.21	Survival Status Follow-up	9.21. Survival Status Follow-up Overall survival status will be collected during the survival follow-up period every 3 months (±2 weeks) from the patient's previous visit. For the Phase 1 Expansion part of the study, patients should be followed for up to 12 months after the last patient enrolled in this phase of the st...	[]
NCT02052778	10	EFFICACY ASSESSMENT CRITERIA	10. EFFICACY ASSESSMENT CRITERIA	[]
NCT02052778	10.1	Efficacy Assessment for Solid Tumors	10.1. Efficacy Assessment for Solid Tumors The determination of antitumor efficacy will be based on objective tumor assessments made by the investigator according to the revised RECIST guidelines (version 1.1, 2009) of unidimensional evaluation.17 For Phase 1 Expansion, the primary endpoint is ORR (and EPR for GBM or g...	[]
NCT02052778	10.1.1	Method of Imaging	10.1.1. Method of Imaging All patients with and without measurable disease will be eligible for assessment. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at Screening and during follow-up. Imaging-based evaluation is preferred to evaluation by cl...	[]
NCT02052778	10.1.2	Tumor Definitions	10.1.2. Tumor Definitions Measurable Lesions: - ! Measurable visceral lesions: Lesions that can be accurately measured in at least 1 dimension with the longest diameter (to be recorded) ∀ 10 mm by CT scan if using slice thickness of 5 mm or less, or at least double the slice thickness of the CT or MRI scan if the slic...	[ "Measurable Lesions:", "Target Lesions:", "Non-target Lesions:" ]
NCT02052778	10.1.3	Response Criteria	10.1.3. Response Criteria On-site assessments will include the assessment of: - ! Target and non-target tumor responses - ! Objective response The above assessments will be made as per the time points identified in Section 9.17, Solid Tumor Assessments/Scans.	[]
NCT02052778	10.1.3.1	Target and Non-Target Response Assessments	10.1.3.1. Target and Non-Target Response Assessments \| TAS-120 \| \| \|------------------------------------------------------------------\|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------...	[ "Progression in Non-target Disease:" ]
NCT02052778	10.1.3.1.1	Additional Criteria to Consider When Making Tumor Response Assessments	10.1.3.1.1. Additional Criteria to Consider When Making Tumor Response Assessments When effusions are known to be a potential adverse effect of treatment, cytological confirmation of the neoplastic origin of any effusion that appears or worsens during treatment when the measurable tumor has met criteria for response or...	[]
NCT02052778	10.1.3.2	Objective Response Assessment	10.1.3.2. Objective Response Assessment Assessments will be based on the definitions provided in Table 13 and Table 14. Table 13: Time Point Response for Patients with Target (+/- Non-Target) Disease \| Target Lesions \| Non-Target Lesions \| New Lesions \| Objective Response \| \|-------------------\|------------------------...	[]
NCT02052778	10.1.4	Best Objective Response Assessment for Solid Tumors	10.1.4. Best Objective Response Assessment for Solid Tumors The best objective response for solid tumors will be assessed as defined in the Statistical Analysis Plan (SAP) per RECIST guideline (version 1.1, 2009). To be assigned a status of PR or CR for Phase 1 Expansion and Phase 2, changes in tumor measurements in pa...	[]
NCT02052778	10.2	Efficacy Assessment for Brain Tumors	10.2. Efficacy Assessment for Brain Tumors	[]
NCT02052778	10.2.1	Method of Imaging	10.2.1. Method of Imaging Patients with brain tumors will be evaluated for response by contrast MRI (e.g., Gd-MRI). All MRIs should be performed when the patient is on a stable dose of steroids. Gd-MRI will be performed at screening, end of every 2 cycles (up to + 2 weeks) in the first 4 cycles and every 3 cycles (± 7 ...	[]
NCT02052778	10.2.2	Tumor Definitions	10.2.2. Tumor Definitions	[]
NCT02052778	10.2.2.1	Measurable and Non-measurable Contrast Enhancing Lesions	10.2.2.1. Measurable and Non-measurable Contrast Enhancing Lesions Measurable Lesions/Target Lesions To evaluate changes in brain tumors using the RANO criteria, weighted images will be measured and monitored for response over time for up to 5 enhancing lesions identified on baseline T1 (T1 relaxation time constant). ...	[ "Measurable Lesions/Target Lesions", "Non-measurable Lesions" ]
NCT02052778	10.2.2.2	Non-enhancing Lesions	10.2.2.2. Non-enhancing Lesions Non-enhancing lesions visualized with T2-weighted fluid-attenuated inversion recovery (T2/FLAIR) will also be assessed when evaluating tumor response. Non-enhancing lesions will not be measured, but instead will be monitored for changes in size. It is important to note that the extent of...	[]
NCT02052778	10.2.3	Response Definitions	10.2.3. Response Definitions Brain tumor response to therapy will be categorized into one of four categories: complete response, partial response, stable disease, or progression. Complete Response Complete response (CR) will be achieved if all enhancing (measurable and non-measurable) lesions have disappeared for at l...	[ "Complete Response", "Partial Response", "Stable Disease", "Progressive Disease" ]
NCT02052778	11	REPORTING SAFETY INFORMATION	11. REPORTING SAFETY INFORMATION	[]
NCT02052778	11.1	Adverse Events/Serious Adverse Events	11.1. Adverse Events/Serious Adverse Events	[]
NCT02052778	11.1.1	Adverse Events	11.1.1. Adverse Events An AE is any untoward medical condition that occurs in a patient from the time the ICF is signed and does not necessarily have a causal relationship with the use of the product. A complete and specific clinical diagnosis should be provided for the AE verbatim term. If a diagnosis is not available...	[]
NCT02052778	11.1.2	Serious Adverse Events	11.1.2. Serious Adverse Events An SAE is an AE that falls into one or more of the following categories: - a. Results in death. - b. Is life threatening (e.g., an event that, in the view of the investigator, places the patient at immediate risk of death from the event as it occurred [it does not include an event, which ...	[]
NCT02052778	11.1.3	Reporting of Deaths	11.1.3. Reporting of Deaths All deaths including death due to clinical disease progression occurring through the 30-day follow-up period must be reported as an SAE within 24 hours: ! Death is not an acceptable AE/SAE term. Death is an outcome of an SAE. When reporting a death, site personnel will be required to identif...	[]
NCT02052778	11.1.4	Disease Progression	11.1.4. Disease Progression How to report events related to nonfatal disease progression: ! Disease progression is not an acceptable AE term. In cases of nonfatal disease progression, the relevant signs, symptoms and complications that led to the diagnosis of clinical disease progression should be reported as an AE. If...	[]
NCT02052778	11.1.5	Pregnancy	11.1.5. Pregnancy If a patient becomes pregnant while in the study, the study treatment must be immediately discontinued. Pregnancy information in a female patient or in the female partner of a male patient should be reported within 24 hours from the time the investigator first becomes aware of a pregnancy or its outco...	[]
NCT02052778	11.1.6	Overdose	11.1.6. Overdose An overdose with TAS-120 for this clinical trial is defined as taking a dose beyond the protocoldefined dose (taking into account any dose reductions / re-escalations) in 1 day. An overdose of TAS-120 must be reported to TOI Pharmacovigilance or designee within 24 hours from the time the investigator f...	[]
NCT02052778	11.1.7	Medication Errors	11.1.7. Medication Errors A medication error for this clinical trial is defined as an accidental, incorrect administration of a medicinal product. The error can be related to the administration of a wrong medication, nature of the medication, route of administration, dosage, or frequency of the treatment (including omi...	[]
NCT02052778	11.1.8	Breaking the Study Blind	11.1.8. Breaking the Study Blind This is an open-label study.	[]
NCT02052778	11.2	Laboratory Evaluations	11.2. Laboratory Evaluations	[]
NCT02052778	11.2.1	Reporting and Evaluation of Laboratory Test Results	11.2.1. Reporting and Evaluation of Laboratory Test Results Laboratory tests will be performed as required per protocol. All laboratory values that are out of the normal range will be evaluated for their clinical significance before exposing the patient to the next dose of TAS-120. The laboratory must provide normal re...	[]
NCT02052778	11.2.2	Repeat Testing	11.2.2. Repeat Testing Evaluation of any clinically significant laboratory test will be repeated, as clinically indicated, until the value returns to the baseline level or clinically stabilizes, or until new anticancer treatment, surgery, or radiotherapy is given.	[]
NCT02052778	11.3	Physical Examination and Performance Status	11.3. Physical Examination and Performance Status Physical examinations and performance status evaluations will be performed as described in the Study Procedures section of the protocol. If changes are observed, the investigator will determine whether they meet the definition of an AE. All observations and evaluations ...	[]
NCT02052778	11.4	Vital Signs and Body Weight	11.4. Vital Signs and Body Weight Vital signs and body weight will be verified and documented. If a clinically significant change is observed, the measurement will be repeated as clinically indicated and evaluated for its clinical relevance and whether it meets the definition of an AE.	[]
NCT02052778	12	STATISTICS	12. STATISTICS This section outlines the statistical methodology to be used to summarize the study results. A SAP will be prepared as a separate document. The SAP will include a more technical and detailed description of the planned statistical summaries and will be finalized prior to closing of the database.	[]
NCT02052778	12.1	Study Populations	12.1. Study Populations The study populations include safety, DLT-evaluable, PK, pharmacodynamic, and efficacy populations. Safety Population The safety population will include all patients who received at least 1 dose of TAS-120. This population will be the primary population for safety evaluation. DLT Evaluable Pop...	[ "Safety Population", "DLT Evaluable Population (Phase 1 Dose Escalation only)", "PK and Pharmacodynamic Population", "Efficacy Population" ]
NCT02052778	12.2	Statistical Analysis	12.2. Statistical Analysis	[]
NCT02052778	12.2.1	Patient Disposition, Baseline and Treatment Characteristics	12.2.1. Patient Disposition, Baseline and Treatment Characteristics	[]
NCT02052778	12.2.1.1	Patient Disposition	12.2.1.1. Patient Disposition The number of patients in each study population and the reasons for exclusion will be summarized. In addition, patients' status with regard to study treatment and follow-up will also be summarized, along with the reasons for study discontinuation.	[]
NCT02052778	12.2.1.2	Patient Baseline Characteristics	12.2.1.2. Patient Baseline Characteristics Patient disease and baseline characteristics will be summarized using frequency distribution or descriptive statistics as appropriate.	[]
NCT02052778	12.2.1.3	Study Treatment	12.2.1.3. Study Treatment The TAS-120 administration profile will be summarized with respect to number of cycles taken, the dose intensity, dose modifications, and reasons for deviations from the planned regimen.	[]
NCT02052778	12.2.2	Efficacy Analysis	12.2.2. Efficacy Analysis Tumor assessments will be performed as per Section 9.17, Tumor Assessments/Scans. For the Phase 1 Expansion, the primary endpoint is ORR (and EPR for primary CNS tumors), and secondary endpoints are DCR, DOR, PFS, OS. For Phase 2, the primary endpoint is ORR and the secondary endpoints are DOR...	[]
NCT02052778	12.2.2.1	Objective Response Rate	12.2.2.1. Objective Response Rate Objective response rate (ORR) is defined as the proportion of patients with objective evidence of CR or PR. The evaluation of ORR will be based on investigator assessment and/or central independent review of the images as follows: - ! Phase 1 dose escalation: Local CT/MRI assessment an...	[]
NCT02052778	12.2.2.2	Disease Control Rate	12.2.2.2. Disease Control Rate The assessment of DCR will parallel that of ORR, with DCR defined as the proportion of patients with objective evidence of CR, PR, or SD, except that there is no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation. Disease c...	[]
NCT02052778	12.2.2.3	Duration of Response	12.2.2.3. Duration of Response Duration of response (DOR) is derived for those patients with objective evidence of PR or CR. Duration of response is defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occu...	[]
NCT02052778	12.2.2.4	Progression-free Survival	12.2.2.4. Progression-free Survival Progression-free survival (PFS) is defined as the time from the day of the first dose to the date of first objectively documented disease progression or death (any cause), whichever occurs first. Patients who die without a reported disease progression will be considered to have progr...	[]
NCT02052778	12.2.2.5	Overall Survival	12.2.2.5. Overall Survival Overall survival (OS) is defined as the time (in months) from the date of the first dose to the death date, in the safety population for the Phase 1 Dose Escalation and Phase 1 Expansion parts of the study and the efficacy population for the Phase 2 part of the study. In the absence of death ...	[]
NCT02052778	12.2.2.6	Patient-Reported Outcomes	12.2.2.6. Patient-Reported Outcomes The analyses of EQ-5D and EORTC QLQ-C30 will be performed in all treated patients who have an assessment at baseline and at least one subsequent assessment. EQ-5D Patient's overall health state on a visual analog scale (EQ-VAS) at each assessment time point will be summarized using ...	[ "EQ-5D", "EORTC QLQ-C30" ]
NCT02052778	12.2.3	Safety	12.2.3. Safety The safety evaluations will focus on the AEs and laboratory assessments. All patients included in the safety population will be evaluated in the safety analysis. Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicit...	[]
NCT02052778	12.2.4	Pharmacokinetic Analysis	12.2.4. Pharmacokinetic Analysis For Phase 1, the PK parameters in plasma and urine will be calculated by standard noncompartmental methods. In addition, the accumulation ratio will be also calculated for the last Wednesday of Cycle 1 (QOD arm) or Day 21 (QD arm) after repeated administrations, as applicable. Dose-prop...	[]
NCT02052778	12.2.5	Pharmacodynamic Analysis (Phase 1 Dose Escalation only)	12.2.5. Pharmacodynamic Analysis (Phase 1 Dose Escalation only) Pharmacodynamic data (FGF23 and phosphorus in serum, and phosphorus and calcium in urine) for individual time data will be summarized descriptively by dose level and schedule. Where possible, relationship between plasma PK parameters or concentration of TA...	[]
NCT02052778	13	ETHICS	13. ETHICS	[]
NCT02052778	13.1	Ethical Considerations	13.1. Ethical Considerations It is mandatory that all considerations regarding the protection of human subjects be carried out in accordance with the protocol, Good Clinical Practice (GCP), ICH Guidelines, the ethical principles that have their origin in the Declaration of Helsinki, and all applicable regulatory requir...	[]
NCT02052778	13.2	Informed Consent and Patient Information	13.2. Informed Consent and Patient Information Obtaining informed consent must be done according to the guidelines provided in the Declaration of Helsinki, ICH E6 Guideline for GCP, and local regulations. The investigator (according to applicable regulatory requirements) or a person designated by the investigator and u...	[]
NCT02052778	13.3	Institutional Review Board/Independent Ethics Committee Approval	13.3. Institutional Review Board/Independent Ethics Committee Approval The study must be approved by an appropriately constituted IRB/IEC, as required in Chapter 3 of the ICH E6 Guidelines, applicable local regulations, and, for studies conducted under an Investigational New Drug (IND) application, the United States of...	[]
NCT02052778	13.4	Post-study Provisions	13.4. Post-study Provisions After the completion of the study, if a patient still requires administration of study drug which has been assessed as beneficial per the investigator, the Sponsor and investigator will discuss the post-study provisions for the patient's access to study drug. At that time, patients will foll...	[]
NCT02052778	14	ADMINISTRATIVE CONSIDERATIONS	14. ADMINISTRATIVE CONSIDERATIONS	[]
NCT02052778	14.1	Protocol Amendments	14.1. Protocol Amendments No change to the protocol may be made without the joint agreement of both the investigator and sponsor. Any amendment to the original protocol will be made by sponsor and will be signed by both parties and submitted to the IRB/IEC and appropriate regulatory authorities for approval or notifica...	[]
NCT02052778	14.2	Curriculum Vitae	14.2. Curriculum Vitae All investigators and any subinvestigator(s) must provide sponsor with current (within 2 years) signed and dated copies of their own curriculum vitae listing the experience, qualifications, and training prior to the beginning of the study.	[]
NCT02052778	14.3	Administrative Structure	14.3. Administrative Structure The administrative structure of the study (e.g., CROs) will be provided to all sites. In addition to ongoing safety monitoring during the study, a more comprehensive evaluation of the ongoing study safety profile will take place when key study milestones are met, such as completion of the...	[]
NCT02052778	14.4	Monitoring Procedures	14.4. Monitoring Procedures	[]
NCT02052778	14.4.1	Investigator's Responsibilities	14.4.1. Investigator's Responsibilities The investigator agrees to conduct the study in accordance with the Clinical Trial Protocol, ICH guidelines E6 – GCP, Section 4 – investigator's obligations and the applicable regulatory requirements. The investigator is required to ensure compliance with the protocol and other p...	[]
NCT02052778	14.4.2	Sponsor's Responsibilities	14.4.2. Sponsor's Responsibilities The sponsor is responsible to health authorities for taking all reasonable steps to ensure the proper conduct of the clinical trial protocol with regard to ethics, protocol compliance, and integrity and validity of the data recorded in the eCRFs. Thus, the main duty of the monitor is ...	[]
NCT02052778	14.4.3	Source Documents	14.4.3. Source Documents According to ICH guidelines the monitor will check the eCRF entries against the source documents. Source documents are original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, patient's evaluation checklists, pharmacy dispensing rec...	[]
NCT02052778	14.4.4	Case Report Form	14.4.4. Case Report Form Investigators will be provided with detailed eCRF Completion Guidelines that will identify the required data points to be collected, how to document them, and when the data should be documented. It is the responsibility of the investigator to maintain adequate and accurate eCRFs to record (acco...	[]
NCT02052778	14.4.5	Sponsor's Audits and Regulatory Inspections	14.4.5. Sponsor's Audits and Regulatory Inspections For the purpose of ensuring compliance with the protocol, GCP and applicable regulatory requirements, the investigator will permit auditing by the sponsor or its representative and inspections by regulatory authorities. The investigator agrees to allow the auditors an...	[]
NCT02052778	14.5	Archiving of Records	14.5. Archiving of Records The investigator is responsible for the retention of all study documents according to institutional policies, local laws, ICH Parts 4.9.4 and 4.9.5 and, for studies conducted under an IND application, the USA CFR Title 21 Part 312.62. For more information on USA requirements and ICH Guideline...	[]
NCT02052778	14.6	Final Report	14.6. Final Report Whether the study is completed or prematurely terminated, a final report of the study will be written by the sponsor or its designee and submitted to the regulatory agency(ies), as required by the applicable regulations. The final study report will be retained by the sponsor, or by any other subseque...	[]
NCT02052778	14.7	Use and Publication of Study Results	14.7. Use and Publication of Study Results All unpublished documentation (including the protocol, eCRF, and IB) given to the investigator is strictly confidential. All recipients must agree not to disclose the information contained herein to any person without the prior written authorization of the sponsor. The submiss...	[]
NCT02052778	14.8	Financial Disclosure	14.8. Financial Disclosure Financial disclosure for clinical investigators and record keeping of financial records will be in accordance with local regulatory requirements.	[]
NCT02052778	14.9	Termination of the Study	14.9. Termination of the Study In the event that the investigator is unable to continue the study and another suitable person is designated as the investigator, the sponsor must be notified in advance (30 days prior to notice). The new investigator must accept the responsibility in writing and be approved by the sponso...	[]

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