protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01799993 | 9.7 | Data Quality | 9.7 Data Quality Monitoring and auditing procedures defined/agreed to by the sponsor will be followed, in order to comply with GCP guidelines. Each center will be visited at regular intervals by a Monitor to ensure compliance with the study protocol, GCP and legal aspects. This will include on-site checking of the CRF ... | [] |
NCT01799993 | 9.8 | Documentation | 9.8 Documentation Entries made in the CRF must be either verifiable against source documents, or have been directly entered into the CRF, in which case the entry in the CRF will be considered as the source data. The source data parameter to be verified and the identification of the source document must be documented. T... | [] |
NCT01799993 | 10 | Ethical and Legal Aspects | 10. Ethical and Legal Aspects | [] |
NCT01799993 | 10.1 | Independent Ethics Committee (IEC) or Institutional Review Board (IRB) | 10.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB) Documented approval from appropriate IECs/IRBs will be obtained for all participating centers/countries prior to study start, according to GCP, local laws, regulations and organizations. When necessary, an extension, amendment or renewal of the... | [] |
NCT01799993 | 10.2 | Ethical Conduct of the Study | 10.2 Ethical 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 under the guiding principles detailed in the Declaration of Helsinki. The study will als... | [] |
NCT01799993 | 10.3 | Regulatory Authority Approvals/Authorizations | 10.3 Regulatory Authority Approvals/Authorizations Regulatory Authority approvals / authorizations / notifications, where required, must be in place and fully documented prior to study start. | [] |
NCT01799993 | 10.4 | Patient Information and Consent - amended | 10.4 Patient Information and Consent - amended A core information and ICF will be provided. Prior to the beginning of the study, the investigator must have the IEC/IRB written approval/favorable opinion of the written ICF and any other written information to be provided to patients. The written approval of the IEC/IRB ... | [] |
NCT01799993 | 10.5 | Insurance | 10.5 Insurance All patients participating in the study will have insurance coverage by the sponsor, which is in line with applicable laws and/or regulations. | [] |
NCT01799993 | 10.6 | Confidentiality | 10.6 Confidentiality All records identifying the patient will be kept confidential and, to the extent permitted by the applicable laws and / or regulations, will not be made publicly available. Patient names will not be supplied to the sponsor. Only the patient number will be recorded in the CRF. If the patient name ap... | [] |
NCT01799993 | 11 | Statistical Methods and Determination of Sample Size | 11. Statistical Methods and Determination of Sample Size | [] |
NCT01799993 | 11.1 | Statistical and Analytical Plans | 11.1 Statistical and Analytical Plans | [] |
NCT01799993 | 11.1.1 | Analysis Populations - amended | 11.1.1 Analysis Populations - amended The two populations used for analysis will be the mITT population and the ITT population. These populations will be comprised of patients recruited to this study and to study 13085 (being conducted in different countries; the protocols are identical with the exception that study 13... | [] |
NCT01799993 | 11.1.2 | Analytical Plan - amended | 11.1.2 Analytical Plan - amended The primary efficacy analysis will be conducted in the mITT population. The primary analysis is on the combined database, no single study analyses will be performed as part of the primary analysis.[90](#page-60-6) Unless otherwise specified, all significance tests will be conducted usin... | [] |
NCT01799993 | 11.2 | Determination of Sample Size - amended | 11.2 Determination of Sample Size - amended [91](#page-60-7)For this combined study (studies 13084 and 13085), a two group 2 test with a 0.05 twosided significance level will have 81% power to detect the difference between BAY 41-6551 survival rate at LFU of 80% and Placebo survival rate at LFU of 69% when the sample s... | [] |
NCT01799993 | 11.3 | Methods for the Analysis of the Primary Efficacy Parameter (Survival) amended | 11.3 Methods for the Analysis of the Primary Efficacy Parameter (Survival) amended [92](#page-61-1)The primary efficacy variable is Survival through the LFU visit. Survival is achieved when the patient is alive through the LFU visit. No other factors are considered in the evaluation of survival. The primary analysis wi... | [] |
NCT01799993 | 11.4 | Methods for the Analysis of Secondary Efficacy Parameters - amended | 11.4 Methods for the Analysis of Secondary Efficacy Parameters - amended [93](#page-63-1) If the null hypothesis for the primary efficacy variable is rejected, a formal hypothesis testing scenario will be applied for the secondary efficacy variables: - Pneumonia-related mortality through the LFU visit (determined by bl... | [] |
NCT01799993 | 11.5 | Additional Analyses of Clinical Success - amended | 11.5 Additional Analyses of Clinical Success - amended [95](#page-64-3) The following endpoints will be analyzed as additional analyses of clinical success: | [] |
NCT01799993 | 11.5.1 | Foundation for the National Institute of Health Criteria - amended | 11.5.1 Foundation for the National Institute of Health Criteria - amended Clinical success using FNIH recommendations is defined as mITT patients who survived through the LFU visit and did not have septic shock. Patients will be designated as having a 94 Revised with Amendment 8 95 Section added per Amendment 8 ![](pag... | [] |
NCT01799993 | 11.5.2 | Investigator Assessment of Patient Outcome - amended | 11.5.2 Investigator Assessment of Patient Outcome - amended Investigator Assessment of Patient Outcome is determined at the TOC visit. The outcomes of "success" or "failure" are based on the following criteria: - Improvement or lack of progression of all abnormalities on chest radiograph - Resolution towards normal of ... | [] |
NCT01799993 | 11.5.3 | Clinical Success (Former 5 Component Primary Endpoint) - amended | 11.5.3 Clinical Success (Former 5 Component Primary Endpoint) - amended Clinical Success is achieved when the following criteria are met as listed in the order of medical relevance: - The patient must survive through the Late Follow-Up (LFU) visit - Systemic antibiotics (IV or PO) for pneumonia must be stopped on or be... | [
"Stable respiratory function",
"Unstable respiratory function"
] |
NCT01799993 | 11.6 | Analysis of Device Performance | 11.6 Analysis of Device Performance Device performance will be summarized descriptively as reported events, incidents, complaints and analysis of planned return units. No inferential statistics will be provided. | [] |
NCT01799993 | 11.7 | Analysis of Safety Data | 11.7 Analysis of Safety Data All analyses of safety endpoints will be descriptive only, and no inferential statistics will be provided. The proportion of patients with organ failure will be summarized by treatment group. The overall proportion of patients with any organ failure will be summarized, as well as the propor... | [] |
NCT01799993 | 11.8 | Methods for the Analysis of the Microbiology Endpoints | 11.8 Methods for the Analysis of the Microbiology Endpoints Summaries of microbiologic endpoints will only be provided for the mITT population. By-patient and by-organism bacteriological eradication rates at the TOC visit will be provided for each treatment group. In these summaries, eradication rates will be defined a... | [] |
NCT01799993 | 12 | Adverse Events | 12. Adverse Events | [] |
NCT01799993 | 12.1 | Definitions | 12.1 Definitions | [] |
NCT01799993 | 12.1.1 | Adverse Event | 12.1.1 Adverse Event An AE is any untoward undesirable experience associated with the use of a medicinal product or medical device in a patient. The AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laborator... | [] |
NCT01799993 | 12.1.2 | Serious Adverse Event | 12.1.2 Serious Adverse Event An SAE is any untoward medical occurrence that at any dose: - Results in death. - Is life-threatening. - Requires in-patient hospitalization or prolongation of existing hospitalization. - Results in persistent or significant disability or incapacity. - Is a congenital anomaly or birth defec... | [] |
NCT01799993 | 12.1.3 | Unexpected Adverse Event | 12.1.3 Unexpected Adverse Event An unexpected AE is any adverse drug event, the specificity or severity of which is not consistent with the current Investigator Brochure (or Package Insert for marketed products). Also, reports which add significant information on specificity or severity of a known, already documented A... | [] |
NCT01799993 | 12.1.4 | Adverse Events of Special Safety Interest | 12.1.4 Adverse Events of Special Safety Interest Identified risks of parenteral (IV and IM) formulations of amikacin (eg, neurotoxicity, ototoxicity, and nephrotoxicity) should be monitored to assess the potential risk for aerosolized amikacin. Adverse effects due to local exposure in the bronchopulmonary system, such ... | [] |
NCT01799993 | 12.1.5 | Relationship of Adverse Event to Investigational Product | 12.1.5 Relationship of Adverse Event to Investigational Product The assessment of the relationship of an AE to the administration of study drug is a clinical decision based on all available information at the time of the completion of the CRF. An assessment of 'No' would include: 1. The existence of a clear alternative... | [
"OR"
] |
NCT01799993 | 12.1.6 | Severity of the Adverse Event | 12.1.6 Severity of the Adverse Event The following classification should be used: The severity of AEs should be graded as follows:  29 Aug 2017 Version 9.0 Page: 72 of 157 Mild – usually transient in nature and generally not interfering with normal activities Moderate – sufficiently discomfortin... | [] |
NCT01799993 | 12.1.7 | Adverse Event Documentation | 12.1.7 Adverse Event Documentation All AEs occurring after the patient has signed the informed consent until the completion of the end of study visit must be fully recorded in the patient's CRF and transcribed to the electronic CRF (eCRF). Documentation must be supported by an entry in the patient's file. A laboratory ... | [] |
NCT01799993 | 12.2 | Reporting of Serious Adverse Events/Pregnancy | 12.2 Reporting of Serious Adverse Events/Pregnancy All investigators will be trained on all relevant aspects of the investigator's reporting obligations for SAEs. This information, including all relevant contact details, is summarized in the investigator site file. This information will be updated as needed. Serious AE... | [] |
NCT01799993 | 12.2.1 | Notification of the IECs/IRBs | 12.2.1 Notification of the IECs/IRBs Notification of the IECs/IRBs about all relevant events (eg, SAEs, SUSARs) will be performed by the sponsor or delegated to a CRO and/or by the investigator according to all applicable regulations.  29 Aug 2017 Version 9.0 Page: 73 of 157 | [] |
NCT01799993 | 12.2.2 | Notification of the Authorities | 12.2.2 Notification of the Authorities The processing and reporting of all relevant events (eg, SAEs, SUSARs) to the authorities will be done by the sponsor according to all applicable regulations. | [] |
NCT01799993 | 12.2.3 | Sponsor's Notification of the Investigational Site | 12.2.3 Sponsor's Notification of the Investigational Site The sponsor or sponsor's designee will inform all investigational sites about reported relevant events (eg, SUSARs) according to all applicable regulations. | [] |
NCT01799993 | 12.3 | Definition of an Incident | 12.3 Definition of an Incident An incident is any malfunction or deterioration in the characteristics and/or performance of the device, as well as any inadequacy in the labeling or the instructions for use, which directly or indirectly, might lead to or might have led to the death or to a serious deterioration in the s... | [] |
NCT01799993 | 12.3.1 | Device Malfunction or Failure and Medical Device Reporting | 12.3.1 Device Malfunction or Failure and Medical Device Reporting Any device complaint, malfunction, or failure including use errors will be recorded by the clinical/investigational site, including all relevant device information using the clinical investigations device complaint form, and forwarded within 24 hours to ... | [
"Investigator's notification of the sponsor"
] |
NCT01799993 | 13 | Use of Data and Publication | 13. Use of Data and Publication All data and results and all intellectual property rights in the data and results derived from the study will be the property of the sponsor, who may utilize the data in various ways, such as for submission to government regulatory authorities or disclosure to other investigators. The in... | [] |
NCT01799993 | 14 | References - amended | 14. References - amended - 1. Schaad UB, Wedgewood-Krucko J, Suter S, et al. Efficacy of inhaled amikacin as an adjunct to intravenous combination therapy (ceftazidime and amikacin) in cystic fibrosis. J Pediatr 1987;111(4):599-605. - 2. Dequin P-F, Faurisson F, Lemarie E, et al. Urinary excretion reflects lung deposit... | [] |
NCT01799993 | 15 | Appendices | 15. Appendices | [] |
NCT01799993 | 15.1 | Study Flow Chart and Schedule of Procedures - Amended | 15.1 Study Flow Chart and Schedule of Procedures - Amended | | | | | | | | Day | | | | | | | | | |-----------------------------------------------------|-----------|---|---|---|---|---|-----|---|---|---|-------------|--------------------------------------|------------------------|----------------------------------------... | [] |
NCT01799993 | 15.2 | Pulmonary Drug Delivery System (PDDS Clinical) | 15.2 Pulmonary Drug Delivery System (PDDS Clinical) Figure 1: PDDS Clinical for Ventilator Application  29 Aug 2017 Version 9.0 Page 84 of 157 Figure 2: PDDS Clinical on Vent Configuration   Figure 3: PDDS Nebulizer/Reservoir Inserted Into the Hand... | [] |
NCT01799993 | 15.3 | Clinical Pulmonary Infection Score (CPIS) - amended | 15.3 Clinical Pulmonary Infection Score (CPIS) - amended | CPIS Points | 0 | 1 | 2 | |-----------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------|-----------------------... | [
"Guidance for Investigators for Calculating the CPIS"
] |
NCT01799993 | 15.4 | National Institute of Health Stroke Scale | 15.4 National Institute of Health Stroke Scale | Tested Item | Title | Scores and Responses | |-------------|---------------------------|------------------------------------| | 1A | Level of consciousness | 0 – alert | | | | 1 – drowsy | | | | 2 – obtunded | | | | 3 – coma/unresponsive | | 1B | Orientation questions (2... | [] |
NCT01799993 | 15.5 | APACHE II Score / Glasgow Score - amended | 15.5 APACHE II Score / Glasgow Score - amended The Acute Physiology and Chronic Health Evaluation II is a severity of disease classification system (Knaus et al, 1985)[46](#page-79-2), one of several ICU scoring systems. After admission of a patient to an ICU, an integer score from 0 to 71 is computed based on several ... | [] |
NCT01799993 | 15.6 | Late Follow-Up Questionnaire | 15.6 Late Follow-Up Questionnaire Patients will be strongly encouraged to return to their study facility for their LFU. This questionnaire needs to be completed whether in-person (ie, face-to-face) or via phone contact with the patient, or the patient's care giver including recording concomitant medication and AEs. - 1... | [] |
NCT01799993 | 15.7 | Guidance on Tracheal Aspirate Sampling Technique | 15.7 Guidance on Tracheal Aspirate Sampling Technique (Adapted from the American Association for Respiratory Care (AARC) Clinical Practice Guideline, 2010)[47](#page-79-3) Tracheal aspiration through a closed or open suction system for Gram-stain, bacterial culture, or amikacin levels will be performed according to the... | [] |
NCT01799993 | 15.8 | SpO2 – Estimated PaO2 Conversion Table | 15.8 SpO2 – Estimated PaO2 Conversion Table | SpO2 | | |---------------------------|----------------| | Pulse oximeter saturation | Estimated PaO2 | | (%) | (mm Hg) | | 100 | 265 | | 99 | 171 | | 98 | 113 | | 97 | 91 | | 96 | 82 | | 95 | 75 | | 94 | 69 | | 93 | 66 | | 92 | 62 | | 91 | 60 | | 90 | 58 | | 89 | 56 | | 88 ... | [] |
NCT01799993 | 15.9 | Adjustment of Empiric IV Antibiotic Therapy (Treatment Algorithm) | 15.9 Adjustment of Empiric IV Antibiotic Therapy (Treatment Algorithm)  \Adjustment of Initial Empiric IV Antibiotic Therapy is based on the results of culture susceptibility data and/or microscopy, an evaluation of the patient's clinical signs/symptoms of pneumonia (eg, temperature, WBC count wi... | [] |
NCT01799993 | 16 | Protocol amendments | 16. Protocol amendments | [] |
NCT01799993 | 16.1 | Amendment 1 | 16.1 Amendment 1 Amendment 1 can be found in integrated protocol version 2.0, dated 17-AUG-2009. | [] |
NCT01799993 | 16.2 | Amendment 2 | 16.2 Amendment 2 Amendment 2 can be found in integrated protocol version 3.0, dated 14-JUN-2010. | [] |
NCT01799993 | 16.3 | Amendment 3 | 16.3 Amendment 3 Amendment 3 can be found in integrated protocol version 4.0, dated 15-MAR-2011. | [] |
NCT01799993 | 16.4 | Amendment 4 | 16.4 Amendment 4 Amendment 4 can be found in integrated protocol version 5.0, dated 31-OCT-2012. | [] |
NCT01799993 | 16.5 | Amendment 5 | 16.5 Amendment 5 Amendment 5 can be found in integrated protocol version 6.0, dated 17 SEP 2014. | [] |
NCT01799993 | 16.6 | Amendment 6 | 16.6 Amendment 6 | [] |
NCT01799993 | 16.6.1 | Overview of Changes | 16.6.1 Overview of Changes To shorten the time required to develop data from the two Phase III clinical studies of the Amikacin Inhale program (BAY 41-6551/No. 13084 [Inhale 1] and BAY 41-6551/No. 13085 [Inhale 2]) to sustain regulatory submission, Bayer decided that the results of both studies should be consolidated i... | [] |
NCT01799993 | 16.6.2 | Changes to the Protocol Text | 16.6.2 Changes to the Protocol Text In this section, all sections affected by this amendment are detailed; the sequence follows the structure of the most recent previous protocol version. Deletions are crossed out and additions are underlined. Minor editorial changes and corrections of typographical errors are not show... | [
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NCT01799993 | 29 | Aug 2017 Version 9.0 Page: 120 of 157 | 29 Aug 2017 Version 9.0 Page: 120 of 157 Old text:
9.6.2.2.3 Late Follow-up Visit (Days 28 - 32) At the LFU visit, the investigator and/or sub-investigator(s) will evaluate the patient's clinical response. As mentioned previously, a patient evaluated at the TOC visit as a Clinical Failure will have that clinical respo... | [
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NCT02052778 | 1 | SYNOPSIS | 1. SYNOPSIS
Title of Study:
PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS | Protocol Number: | TPU-TAS-120-101 | |------------------|-----------------------| | Phase: | 1 / 2 | | Indication: | Advanced solid tumors |
Background: Activating fibroblast growth factor r... | [
"Title of Study:",
"PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS",
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"Phase 1 Dose Escalation",
"Phase 1 Expansion",
"Primary",
"Secondary",
"Phase 2",
"Primary",
"Key secondary",
"Other secondary",
"Study ... |
NCT02052778 | 4 | LIST OF ABBREVIATIONS AND TERMS | 4. LIST OF ABBREVIATIONS AND TERMS Table 3: Abbreviations and Terms | Abbreviation or Term | Explanation | |----------------------|------------------------------------------------| | AE | Adverse event | | Ae% | Urinary excretion rate as % of dose (QOD arm) | | ALT | Alanine aminotransferase | | ANC | Absolute neutroph... | [] |
NCT02052778 | 5 | INTRODUCTION AND STUDY RATIONALE | 5. INTRODUCTION AND STUDY RATIONALE The progression of cancers is caused by a complex series of multiple genetic and molecular events including gene mutations and chromosomal translocations.1 The fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) signaling axis plays an important role in normal organ... | [] |
NCT02052778 | 5.1 | Unmet Medical Need in Treatment of Cholangiocarcinoma | 5.1. Unmet Medical Need in Treatment of Cholangiocarcinoma Cholangiocarcinoma (CCA), a bile duct cancer, is a rare tumor that arises from the malignant transformation of epithelial cells of the bile ducts. It is typically classified as either intrahepatic (iCCA) or extrahepatic (eCCA). Intrahepatic cholangiocarcinoma d... | [] |
NCT02052778 | 5.2 | TAS-120 | 5.2. TAS-120 TAS-120 is a novel selective and irreversible small molecule FGFR inhibitor. | [] |
NCT02052778 | 5.2.1 | Preclinical Experience with TAS-120 | 5.2.1. Preclinical Experience with TAS-120 TAS-120 equally inhibited all 4 subtypes of FGFR and showed high selectivity for FGFR when tested against a panel of 296 kinases. Half maximal inhibitory concentration (IC50) values (nmol/L) were 3.9 for FGFR1, 1.3 for FGFR2, 1.6 for FGFR3, and 8.3 for FGFR4. TAS-120 was highl... | [] |
NCT02052778 | 5.2.2 | Clinical Experience with TAS-120 | 5.2.2. Clinical Experience with TAS-120 Table 4: List of TAS-120 Clinical Trials | Study Number | Number ofPatientsEnrolleda | Number ofPatientsOngoinga | Dose and schedule: numberof patients enrolleda | |--------------|------------------------------------|-----------------------------------|---------------------------... | [] |
NCT02052778 | 5.3 | Study Rationale | 5.3. Study Rationale The FGF/FGFR signaling axis has been well characterized for its role in proliferation, differentiation, migration, and survival, and it is fundamental to embryonic development, regulation of angiogenesis, and wound healing in adults. Dysregulation of the FGFR signaling pathway has been associated w... | [] |
NCT02052778 | 5.4 | Rationale for Selection of RP2D of TAS-120 | 5.4. Rationale for Selection of RP2D of TAS-120 During the Phase 1 Dose Escalation part of the study, dose levels of 4, 8, 16, 20 and 24 mg QD were evaluated. At 24 mg, 3 of 9 evaluable patients experienced a dose-limiting toxicity (DLT) during Cycle 1, thus, 24 mg was determined as the DLT dose level. At 20 mg QD, no ... | [] |
NCT02052778 | 5.5 | Rationale for the Phase 1 Expansion Part of the Study | 5.5. Rationale for the Phase 1 Expansion Part of the Study The Phase 1 Expansion part of the study included a total of 8 treatment groups enrolling different patient populations; 3 of these groups remain open as of Amendment 7 to this protocol. This includes a group of patients with cholangiocarcinoma (CCA), a group of... | [] |
NCT02052778 | 5.6 | Rationale for Phase 2 Part of the Study | 5.6. Rationale for Phase 2 Part of the Study The original design of the Phase 2 portion of the study (enrolling patients with iCCA harboring FGFR2 gene fusions) was based on preliminary anti-tumor activity observed in this population in the Phase 1 portions of the study. Specifically, at the time the Phase 2 portion wa... | [] |
NCT02052778 | 6 | STUDY OBJECTIVES | 6. STUDY OBJECTIVES | [] |
NCT02052778 | 6.1 | Phase 1 Dose Escalation | 6.1. Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Amendment 6. | [] |
NCT02052778 | 6.2 | Phase 1 Expansion | 6.2. Phase 1 Expansion
Primary - ! To evaluate ORR in cholangiocarcinoma (intra-hepatic [iCCA] or extra-hepatic [eCCA]) patients with tumors harboring FGFR2 gene fusions or other FGFR abnormalities. - ! To evaluate ORR and EPR (defined as progression-free rate at the end of Cycle 2) in patients with primary CNS tumors... | [
"Primary",
"Secondary"
] |
NCT02052778 | 6.3 | Phase 2 | 6.3. Phase 2
Primary ! To confirm ORR in iCCA patients with FGFR2 gene fusions or other FGFR2 rearrangements based on independent central radiology review.
Key secondary ! To evaluate DOR
Other secondary - ! To evaluate the safety and tolerability of TAS-120. - ! To evaluate DCR, PFS, and OS - ! To evaluate Patient-... | [
"Primary",
"Key secondary",
"Other secondary",
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NCT02052778 | 7.1.1 | Phase 1 Expansion | 7.1.1. Phase 1 Expansion TAS-120 will be administered orally at 20 mg, QD in 21-day cycles. Approximately 185 patients will be enrolled. Patients are assigned to one of 8 groups based on tumor type and FGFR aberration, as described below. Additional patients may be enrolled to any of the groups as promising clinical ac... | [
"N=100 treated patients"
] |
NCT02052778 | 7.1.3 | Study Duration | 7.1.3. Study Duration Safety monitoring will begin from the time the main study informed consent form (ICF) is signed and will continue for 30 days after the last dose of TAS-120 or until the initiation of another anticancer therapy, whichever occurs first. Patients will receive study treatment until disease progressio... | [] |
NCT02052778 | 7.2 | Study Population | 7.2. Study Population The study population will include male and female patients with advanced solid tumors or primary CNS tumors, according to the following inclusion and exclusion criteria. | [] |
NCT02052778 | 7.2.1 | Inclusion Criteria | 7.2.1. Inclusion Criteria A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: - 1. Provide written informed consent. - 2. Is ∀ 18 years (or according the country's regulatory definition for legal adult age). - 3. Has histologically or cytologically confirmed, locally... | [
"b. Phase 2"
] |
NCT02052778 | 7.2.2 | Exclusion Criteria | 7.2.2. Exclusion Criteria A patient will be excluded from this study if any of the following criteria are met: 1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis. - 2. History and/or current evidence of clinically significant ectopic mineralizatio... | [] |
NCT02052778 | 7.3 | Discontinuation Criteria | 7.3. Discontinuation Criteria A patient is considered discontinued from study treatment when the decision to permanently stop TAS-120 is made. Any TAS-120 discontinuation should be fully documented. | [] |
NCT02052778 | 7.3.1 | End of Treatment Discontinuation Criteria | 7.3.1. End of Treatment Discontinuation Criteria The reason for discontinuation should be documented in the source documents. Patients can be withdrawn from treatment for the following reasons: - ! At the patient's request at any time irrespective of the reason. - ! RECIST-defined disease progression of solid tumors or... | [] |
NCT02052778 | 7.4 | Patient Numbering and Treatment Allocation | 7.4. Patient Numbering and Treatment Allocation Study sites will enter patient demographic and screening data into the eCRF in order to receive a patient number. The eCRF will assign each patient a unique patient number. This patient number will be maintained throughout the study and will not be reassigned. Patients wh... | [
"Phase 1 Expansion and Phase 2:"
] |
NCT02052778 | 7.5 | Replacement Criteria | 7.5. Replacement Criteria No patients will be replaced during the Phase 1 Expansion or Phase 2 parts of the study. | [] |
NCT02052778 | 7.6 | Prohibited Medications and Therapies | 7.6. Prohibited Medications and Therapies Patients are not permitted to receive any other investigational or any other anticancer therapy, including chemotherapy, immunotherapy, biological response modifiers, or antineoplastic endocrine therapy during the study treatment period. | [] |
NCT02052778 | 7.7 | Concomitant Medications and Therapies | 7.7. Concomitant Medications and Therapies The following therapies are permitted: - ! Bisphosphonate - ! Denosumab - ! Concomitant treatment with GnRH agonists or LH-RH agonists is permitted in prostate cancer patients. - ! Non enzyme-inducing anticonvulsants such as: Gabapentin (Neurontin), Lamotrigine (Lamictal) and ... | [
"Hematologic Support",
"Management of Diarrhea",
"Management of Nausea/Vomiting",
"Management of Hyperphosphatemia",
"Drug interactions with TAS-120"
] |
NCT02052778 | 7.7.1 | Effective Contraception During Study | 7.7.1. Effective Contraception During Study Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (no menses for 12 months without an alternative medical cause), or hysterectomy that is clearly documented in the patient's source documents. For WOCBP, includin... | [] |
NCT02052778 | 7.8 | Dietary Restrictions | 7.8. Dietary Restrictions Limitation of phosphate intake including avoidance of foods that are especially high in phosphate, e.g., dairy products, meats, nuts, and other high-protein foods, processed foods, and colas (e.g., Pepsi) is recommended as part of hyperphosphatemia management. Dietary Guidelines for Treatment ... | [] |
NCT02052778 | 8 | STUDY DRUG | 8. STUDY DRUG | [] |
NCT02052778 | 8.1 | Study Drug Administration and Dose Modification Procedures | 8.1. Study Drug Administration and Dose Modification Procedures | [] |
NCT02052778 | 8.1.1 | Study Drug Administration | 8.1.1. Study Drug Administration TAS-120 is supplied as 4 mg tablets. The dose for TAS-120 is 20 mg QD. Patients should follow the instructions of the treating physician on study drug administration during treatment. Patients are required to fast for at least 2 hours before and 1 hour after administration of TAS-120. P... | [] |
NCT02052778 | 8.1.2 | Treatment Regimen | 8.1.2. Treatment Regimen TAS-120 will be administered as a daily, continuous, 21-day treatment cycle until at least 1 of the criteria for study discontinuation is met. TAS-120 must be administered as outlined in Study Drug Administration (Section 8.1.1) and Dose Reduction/Modification Procedures (Section 8.1.3). There ... | [] |
NCT02052778 | 8.1.3 | Dose Reduction/Modification Procedures | 8.1.3. Dose Reduction/Modification Procedures Dosages will be reduced or modified if AEs are observed according to the criteria described below. In the following sections, AE severity grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade criteria (version 4... | [] |
NCT02052778 | 8.1.3.1 | TAS-120 Dose Reductions for Treatment-emergent Toxicities | 8.1.3.1. TAS-120 Dose Reductions for Treatment-emergent Toxicities Dose reductions must be made according to Table 5. Please note the following: - ! A maximum of 2 dose reductions is permitted - ! If toxicities requiring further dose reduction recur after the maximum dose reductions have been made, or when dose reducti... | [] |
NCT02052778 | 8.1.3.1.1 | Dose Interruption and Modification for Nonhematologic Toxicities | 8.1.3.1.1. Dose Interruption and Modification for Nonhematologic Toxicities Dosing modifications for nonhematologic toxicities are provided in Table 6. TAS-120 will be held when the dose interruption criteria are met. Table 6: TAS-120 Dosing Modification for Nonhematologic Toxicities | Gradea | Dose Interruption/Resump... | [] |
NCT02052778 | 8.1.3.1.2 | Dose Interruption and Resumption Criteria for Hematologic Toxicities | 8.1.3.1.2. Dose Interruption and Resumption Criteria for Hematologic Toxicities Criteria for dose interruption and resumption for hematologic toxicities are described in Table 8. Table 8: TAS-120 Dose Interruption and Modification Criteria for Hematologic Toxicities | Recommended Dose Modifications for TAS-120 | | | | ... | [] |
NCT02052778 | 8.2 | Description and Labeling | 8.2. Description and Labeling | [] |
NCT02052778 | 8.2.1 | TAS-120 | 8.2.1. TAS-120 A description and packaging information for the study drug is described in Table 10. Table 10: TAS-120 Product description and packaging information | ProductDescription andDosage Form | Potency/Strength | Appearance | Primary Packaging | |-------------------------------------------|------------------|--... | [] |
NCT02052778 | 8.2.2 | Packaging and Labeling | 8.2.2. Packaging and Labeling TAS-120 tablets will be packaged in child-resistant Dosepak® cards. Labeling will identify tablet counts in each card. The Dosepak® cards will be labeled with at least the following: - a. Protocol number - b. Sponsor name - c. Storage conditions - d. Tablet strength - e. Number of tablets ... | [] |
NCT02052778 | 8.2.3 | Storage | 8.2.3. Storage TAS-120 tablets should be stored in accordance with the label. All study medication must be kept in a locked area with access restricted to specific study personnel. | [] |
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