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Clinical Index of Stable Febrile Neutropenia

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141. Zinforo - ceftaroline fosamil

on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendation for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 21 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion on non-clinical aspects 26 2.3.6. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 34 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 43 (...) 2.4.5. Conclusions on clinical pharmacology 44 2.5. Clinical efficacy 44 2.5.1. Dose response studies 44 2.5.2. Main studies 46 2.5.3. Discussion on clinical efficacy 92 2.5.4. Conclusions on the clinical efficacy 94 2.6. Clinical safety 95 2.6.1. Discussion on clinical safety 105 2.6.2. Conclusions on the clinical safety 105 2.7. Pharmacovigilance 105 2.8. User consultation 119 3. 119 Benefit-Risk Balance 4. 121 RecommendationsZinforo Assessment report Page 4/122 List of abbreviations %T>MIC

2012 European Medicines Agency - EPARs

142. Teysuno - tegafur / gimeracil / oteracil

product quality characteristics, and these in turn lead to the conclusion that the product should have a satisfactory and uniform performance in the clinic. Stability tests indicate that the product under ICH guidelines conditions is chemically stable for the proposed shelf life. 3 6.32 of Vol. 4 Part I of the Rules Governing Medicinal Products in the European Union Teysuno CHMP ASSESSMENT REPORT EMA/CHMP/831565/2010 Page 14/67 2.3. Non-clinical aspects 2.3.1. Pharmacology Primary pharmacodynamic (...) Product 12 2.2.4. Discussion and conclusions on chemical, pharmaceutical and biological aspects 13 2.3. Non-clinical aspects 14 2.3.1. Pharmacology 14 2.3.2. Pharmacokinetics 16 2.3.3. Toxicology 18 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion and conclusions on non-clinical aspects 25 2.4. Clinical aspects 28 2.4.1. Introduction 28 2.4.2. Pharmacokinetics 31 2.4.3. Pharmacodynamics 34 2.4.4. Discussion and Conclusions on clinical pharmacology 35 2.5. Clinical efficacy 35

2011 European Medicines Agency - EPARs

143. Jevtana - cabazitaxel

of quantitation BM Bone metastasis BMI Body Mass Index BSA Body surface area CBZ Cabazitaxel CL Clearance CR / PR Complete response / partial response CT Computed tomography DoE Design of Experiment ECG Electrocardiography ECOG PS Eastern Cooperative Oncology Group performance status EU European Union GALT gut-associated lymphoid tissue GCP Good clinical practice GLP Good laboratory practice GMP Good manufacturing practices HCPC or mHRPC Hormone-resistant prostate cancer or metastatic hormonoe-resistant (...) ICH guidelines conditions is chemically stable for the proposed shelf life. At the time of the CHMP opinion, there were two quality issues that will be resolved as Follow-up Measures within an agreed timeframe. However, none of them is expected to have a negative impact on the Benefit Risk balance of the product. 2.3. Non-clinical aspects 2.3.1. Introduction Cabazitaxel (also known as XRP6258, RPR116258A) is a semi synthetic derivative from 10-deacetyl Baccatin III, which is extracted typically

2011 European Medicines Agency - EPARs

144. Adjuvant chemotherapy for breast cancer: a cost-utility analysis of FEC-D vs. FEC 100

. The resulting QALYs for each regimen were not separately reported, which may have been useful for comparison with the QALYs for other regimens. Costs: Direct medical costs were included and appear to have been appropriate for the perspective. They included the costs of the important side-effect of febrile neutropenia and growth factor. The sources of the resource use and unit costs and the cost adjustment methods were clearly presented. The cost estimates were relevant to the population. Analysis (...) period, and the authors stated that the perspective was that of the Canadian health care system. Effectiveness data: The clinical estimates included time free of disease, the recurrence rate, and deaths. Canadian life tables were used to determine the disease-free survival rates. Hazard rates comparing the two treatments were obtained from the randomised controlled trial (Roche, et al. 2004, 2006). Monetary benefit and utility valuations: The utility weights were assigned to the health states

2008 NHS Economic Evaluation Database.

145. Study With LDE225 in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability (...) date. Exclusion Criteria: Have received more than 3 prior chemotherapy regimens for ABC. Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy. Patients with acute or chronic liver or renal disease or pancreatitis. Patients

2013 Clinical Trials

146. Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer

febrile neutropenia (Conroy et al 2011). LCL161 is a biostable, cell-permeable, small molecular weight Smac-mimetic compound. It is an orally bioavailable pan-IAP inhibitor that demonstrates anti-tumor efficacy as a single agent in a small subset of cell lines, and in many more cell lines and xenograft models when given in combination with paclitaxel. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a formulation that is readily soluble in saline, eliminating the need for lipid-based solvents (...) conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities. Patient has impaired cardiac function or clinically significant cardiac diseases, including any of the following: History or presence of ventricular tachyarrhythmia Presence of unstable atrial fibrillation (ventricular response > 100 bpm); Patients with stable atrial fibrillation are eligible, provided they do not meet any

2013 Clinical Trials

147. Study of Weekly Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients (wCCyd)

reduction within Cycle1 Inability to receive Day 1 dose of Cycle2 due to drug related toxicity persisting from Cycle1 or drug related toxicity newly encountered on Day1 of Cycle2. Hematologic: Grade 4 neutropenia (ANC<0.5x109/L) lasting for ≥7days Febrile neutropenia (ANC<1.0x109/L with a fever ≥38.3ºC) Grade 4 thrombocytopenia (platelets<25.0x109/L) lasting ≥7 days despite dose delay Grade 3-4 thrombocytopenia associated with bleeding Any hematologic toxicity requiring a dose reduction within Cycle1 (...) ) patients. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 63 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A MULTICENTER, OPEN LABEL STUDY OF WEEKLY CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (wCCyd

2013 Clinical Trials

148. A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Dose-Limiting Toxicities (DLTs) in Phase 1 [ Time Frame: Cycle 1 (21 days) ] DLT was defined as any of the following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for >7 days; febrile neutropenia; grade >=3 neutropenic infection; grade >=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=3 pancreatitis; grade >=3 toxicities (excluding grade >=3 laboratory abnormalities not requiring dose modifications) persisting after (...) . Condition or disease Intervention/treatment Phase ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC Drug: PF-06463922 Drug: Crizotinib Phase 2 Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 334 participants Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment Official

2013 Clinical Trials

149. A Study Of PF-06263507 In Patients With Advanced Solid Tumors

Measures : Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: Baseline up to Cycle 2 Day 1 (22 days) ] DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 (...) Neoplasms Drug: PF-06263507 Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 26 participants Masking: None (Open Label) Primary Purpose: Treatment Official Title: A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS Actual Study Start Date : August 8, 2013 Actual Primary Completion Date : June 29, 2015 Actual Study Completion Date : June 29, 2015 Resource links provided by the National Library

2013 Clinical Trials

150. A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced B

medical judgement. Outcome Measures Go to Primary Outcome Measures : Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1 [ Time Frame: Lead-in period (Day -7) up to Day 28 (Cycle 1) ] DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 (...) 13, 2018 Sponsor: Pfizer Information provided by (Responsible Party): Pfizer Study Details Study Description Go to Brief Summary: This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination

2012 Clinical Trials

151. Anti-EGFR Immunoliposomes in Solid Tumors

if no dose limiting toxicity (DLT) occured at a given dose level. The decision to enter a next dose level will be made by the study team after reviewing all available toxicity data of the previous groups. A DLT is defined as any grade 4 toxicity, any grade 3 toxicity lasting more than one week or/and febrile neutropenia grade 3 (defined as neutrophils < 1.0 x 10e9/l and fever > 38.5 °C). Nausea, vomiting, anorexia, and alopecia (grade 2) will be excluded as dose limiting toxicities. Similarly, adverse (...) ) [ Time Frame: after completion of the 1st cycle (day 28) ] The MTD is defined through the occurrence of two dose limiting toxicities (DLTs) at a specific dose level. DLT are defined as any grade 4 toxicity, any grade 3 toxicity lasting more than one week or/and febrile neutropenia grade 3 (defined as neutrophils < 1.0 x 10e9/l and fever > 38.5 °C). Nausea, vomiting, anorexia, and alopecia (grade 2) will be excluded as dose limiting toxicities. Similarly, adverse events that are clearly related

2012 Clinical Trials

152. A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma (CHAMPION 1)

baseline or > 4.0 mg/dL) lasting > 72 hours ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration grade 4 thrombocytopenia (< 25 000/mm³) for > 14 days, despite holding treatment grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding Overall Response Rate (ORR (...) Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 116 participants Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma Study Start Date : July 4, 2012 Actual Primary Completion Date : July 22, 2016 Actual Study Completion Date : October 31, 2018 Resource links provided

2012 Clinical Trials

153. A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

on when the next chemotherapy cycle was started ] A DLT was any of the following adverse events (AEs) in Cycle 1 and considered by the investigator possibly related to glasdegib in combination with chemotherapy: (1) Grade >= 3 non-hematologic toxicity, excluding Grade >= 3 infection, fever (including febrile neutropenia), infusion related AEs, electrolyte abnormalities and ALT/AST elevation that returned to Grade <= 1 or baseline within 7 days; (2) prolonged myelosuppression that lasted longer than 42 (...) : PF-04449913 Drug: Low dose ARA-C (LDAC) Drug: Decitabine Drug: Daunorubicin Drug: Cytarabine Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 255 participants Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment Official Title: A PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW DOSE ARA-C OR DECITABINE

2012 Clinical Trials

154. Study of Weekly Cabazitaxel for Advanced Prostate Cancer

castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start. Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2. "Unfit" patients defined as patients who satisfy at least one of the following criteria: ECOG 2 Dose reduction due to febrile neutropenia during the previous treatment with docetaxel Radiation therapy affecting more than 25% of bone marrow reserve Documented (...) Detailed Description: The efficacy of three-weekly cabazitaxel is accompanied by an appreciable rate of serious side effects and toxic deaths. The toxicity rates observed, including grade III-IV neutropenia, febrile neutropenia and diarrhea, could be an obstacle to the use and management of a drug that, on the other hand, has demonstrated great activity. In the treatment of patients with prostate cancer, who have a larger number of morbidities than patients with breast cancer, we assume the risk

2012 Clinical Trials

155. Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1: Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation. Delay of >2 weeks for next scheduled IC (...) inhibition. To ensure optimal response rates in the trial, to enrich our population for patients likely to achieve the best clinical response to Parp inhibitor based therapy, we will recruit and enroll patients with known BRCA mutations, patients of Jewish ancestry, patients with familial pancreatic cancer, as well as with sporadic pancreatic cancer. We will test patients and their cancers for other inherited or acquired defects in homologous DNA repair. For the phase 1 study, we will enroll up to 30

2011 Clinical Trials

156. BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours

requiring blood transfusion. Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >5.0 × ULN persisted for 7 days or longer (...) Intervention/treatment Phase Neoplasms Drug: Volasertib, low dose, d1q3w Drug: Volasertib, middle dose, d1q3w Drug: Volasertib, high dose, d1q3w Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 15 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: An Open-label Phase I Study of Once Every Three Weeks Intravenous Treatment With BI 6727 in Japanese Patients

2011 Clinical Trials

157. Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

:2 blood samples for the correlation between clinical response and biological parameters Outcome Measures Go to Primary Outcome Measures : Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide [ Time Frame: 28 days = cycle 1 ] A DLT is defined below: Hematological toxicity: Polunuclear neutrophils < 500/mm3 for more than 7 days Febrile neutropenia (Polunuclear neutrophils < 1 000/mm3 and fever > or = 38.5°C (...) cycles = 2 months ] Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria Estimation of the free-progression median time [ Time Frame: Until disease progression ] Time between the inclusion and the disease progression (clinical or radiological) Calculation of the Growth Modulation Index (GMI) [ Time Frame: Until disease progression ] Time to progression on study treatment and time to progression on prior treatment Evaluation of the correlation

2011 Clinical Trials

158. Combination Trial MSC1936369B With Temsirolimus

; any Grade >=3 non-hematological toxicity except Grade 3 asymptomatic increases in liver function tests, diarrhea, nausea or vomiting with duration <= 48 hours and alopecia; Grade 4 neutropenia of >5 days duration or febrile neutropenia of >1 day duration; Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; any treatment interruption >2 weeks due to adverse events; any severe, impairing daily functions or life-threatening, complication or abnormality not defined in NCI-CTCAE (...) : Pimasertib Drug: Temsirolimus Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 33 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase I Dose Escalation Trial of MEK1/2 Inhibitor MSC1936369B Combined With Temsirolimus in Subjects With Advanced Solid Tumors Actual Study Start Date : May 27, 2011 Actual Primary Completion Date

2011 Clinical Trials

159. Trial of Docetaxel and Irinotecan (DI) for Recurrent or Refractory Bone and Soft Tissue Sarcomas.

-hematological toxicity occurred on the day when the dose is due. Irinotecan scheduled at D8 will be omitted if diarrhea of grade 2 or higher occurred on the D10. Doses of docetaxel and irinotecan in the subsequent cycles are reduced by 20% for febrile grade 4 neutropenia (ANC<500/μL). Subsequent dose will be reduced by 20% for the recurrent toxicity. G-CSF is allowed if clinically indicated according to the ASCO guideline (22). Dose of docetaxel in the subsequent cycles are reduced by 20% for grade 2 (...) will be discontinued in patients with grade 4 non-hematological toxicities at the discretion of investigators. Dose modification schedule : Docetaxel and Irinotecan (DI) dose adjustment within a cycle will be made following the guidelines shown in Table 1 and 2 based on weekly WBC count and criteria for adverse events v3.0 (CTCAE). Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 35 participants Intervention Model: Single Group Assignment

2011 Clinical Trials

160. GSK2251052 in Complicated Urinary Tract Infection

Sponsor: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline Study Details Study Description Go to Brief Summary: This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic (...) reticulocyte count of >5% (i.e., reticulocytes >5% of total RBC mass) Subject has known neutropenia or is anticipated to develop neutropenia during the course of the study (i.e., new chemotherapy subject), with absolute neutrophil count less than 1000 cells/mm3 Subject has a known platelet count less than 75,000 cells /mm3 (subjects with platelet counts as low as 50,000 cells /mm3 are eligible if the reduction is historically stable). Subject has an immunocompromising illness; including known human

2011 Clinical Trials

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