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Clinical Index of Stable Febrile Neutropenia

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101. Zydelig - idelalisib

stability studies results indicate that the active substance manufactured by the proposed supplier is sufficiently stable. The stability results justify the proposed retest period in the proposed container. 2.2.3. Finished Medicinal Product Description of the product and pharmaceutical development The aim of the drug development was to develop an immediate release solid dosage formulation that could support patient adherence to the treatment. Idelalisib was first evaluated in Phase 1 clinical trials (...) . Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations for future quality development 15 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 16 2.3.3. Pharmacokinetics 21 2.3.4. Toxicology 21 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 31 2.3.7. Conclusion on the non-clinical aspects 35

2014 European Medicines Agency - EPARs

102. Safety, Tolerability and Pharmacokinetics of AZD1775 Plus MEDI4736 in Patients With Advanced Solid Tumours

Limiting Toxicities (DLTs) [ Time Frame: Up to 28 Days ] DLTs are defined as: Grade 4 haematologic toxicity for ≥7 days, including infection with febrile neutropenia, or Grade 4 thrombocytopenia. Grade 3 thrombocytopenia associated with Grade ≥2 bleeding. Non-haematologic toxicity ≥Grade 3. Grade 3 nausea, vomiting, or diarrhoea that does not respond within 48 hours. Grade 4 nausea, vomiting, and diarrhoea. ALT or AST ≥5 x but ≤8 x ULN that does not resolve to Grade 2 within 5 days. ALT or AST >8 x ULN (...) appropriate. The first day of Cycle 1 in Schedules B, C, and D will be preceded by a lead-in period of AZD1775 monotherapy to enable serial sampling for assessment of pharmacokinetic parameters. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 56 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I Study Assessing the Safety

2015 Clinical Trials

103. Belinostat (Beleodaq)

Belinostat (Beleodaq) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206256Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number 206256 Priority or Standard Priority Submit Date December 8, 2013 Received Date December 9, 2013 PDUFA Goal Date August 8, 2014 Division / Office DHP/OHOP Reviewer Name Hyon-Zu Lee, Pharm.D. Review Completion Date May 16, 2014 Established Name Belinostat Trade Name Beleodaq Therapeutic Class Histone deacetylase inhibitor (...) Drugs 17 2.5 Summary of Presubmission Regulatory Activity Related to Submission 18 2.6 Other Relevant Background Information 21 3 ETHICS AND GOOD CLINICAL PRACTICES 21 3.1 Submission Quality and Integrity 21 3.2 Compliance with Good Clinical Practices 21 3.3 Financial Disclosures 22 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 23 4.1 Chemistry Manufacturing and Controls 23 4.2 Clinical Microbiology 23 4.3 Preclinical Pharmacology/Toxicology 23 4.4 Clinical Pharmacology 24

2013 FDA - Drug Approval Package

104. Telavancin (Vibativ)

HABP/VABP. The trials were randomized, double-blind, active-controlled, multicenter, and multinational. Subjects with Gram-positive HABP/VABP were randomized 1:1 to receive either TLV 10 mg/kg IV q 24 h or VAN 1 g IV q 12 h for 7 to 21 days. Study 0015 enrolled 761 subjects and Study 0019 enrolled 771 subjects. The prespecified primary efficacy analysis was clinical response at the test- of-cure (TOC) assessment, which occurred 7-14 days after the last dose of study drug. The noninferiority margin (...) (TLV-VAN) was prospectively set at 20%. For the noninferiority analyses, the as-treated (AT) and clinically evaluable (CE) populations were considered coprimary. The results of the applicant's prespecified primary analysis are shown in Table 1. Note that to address the Agency's concern regarding uncertainty whether subjects had the disease of interest, only subjects who fulfilled American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guidelines for diagnosis of HABP/VABP were

2013 FDA - Drug Approval Package

105. Phase I/Ib Dose Escalation & Biomarker Study of Ceritinib (LDK378) + Everolimus for Locally Advanced or Metastatic Solid Tumors With an Expansion in Non-Small Cell Lung Cancer (NSCLC) Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expr

to Primary Outcome Measures : Maximum Tolerated Dose (MTD) of Ceritinib plus Everolimus [ Time Frame: 28 days ] MTD defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity (DLT). DLT defined as hematologic grade 4 neutropenia lasting > 7 days or any febrile neutropenia; Delay of treatment > 14 days due to hematologic toxicity; Platelet count < 10K; non-hematologic toxicity grade 3 or higher; however nausea/vomiting, diarrhea and electrolyte (...) within the 2 week prior to study entry to manage CNS symptoms. Non-ALK-positive NSCLC patients with CNS metastasis should have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids. Negative serum or urine pregnancy test beta-Human Chorionic Gonadotropin (beta hCG) within 2 weeks prior to receiving the first dose of study medication for women

2014 Clinical Trials

106. A Phase IB Trial With OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Patients With Selected Advanced Solid Tumors

is 100 mg. Drug: MK-8628 MK-8628 10, 20 and/or 40 mg oral capsules Other Name: OTX105 Outcome Measures Go to Primary Outcome Measures : Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 [ Time Frame: Up to Cycle 1 Day 21 (Up to 21 days) ] A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection (...) . malabsorption) deemed to jeopardize intestinal absorption of MK-8628; Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 is accepted. Known primary central nervous system (CNS) malignancy or CNS involvement; History of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ

2014 Clinical Trials

107. Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections

or chronic obstructive pulmonary disease at baseline, and, in the opinion, of the investigator is not stable on current therapy; the subject has acute severe pain, uncontrolled with conventional medical management; the subject has active peptic ulcer disease; the subject has parkinson's disease; the subject has myasthenia gravis; the subject has history of seizure disorder requiring medications for control. this does not include a history of childhood febrile seizures; the subject has any evidence (...) to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 126 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: A Phase II, Randomized, Two-Part, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Safety, Tolerability, and Efficacy of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial

2014 Clinical Trials

108. Stomach (Gastric) Cancer

longer for patients who received DCF compared with patients who received CF (9.2 months; 95% CI, 8.4–10.6; vs. 8.6 months; 95% CI, 7.2–9.5; HR, 1.29; 95% CI, 1.0–1.6; log-rank P = .02; risk reduction = 23%).[ ][ ] There were high toxicity rates in both arms.[ ] Febrile neutropenia was more common in patients who received DCF (29% vs. 12%), and the death rate on the study was 10.4% for patients on the DCF arm and 9.4% for patients on the CF arm. Whether the CF regimen should be considered as an index (...) group. In contrast to the overall stable trend for noncardia gastric cancers, earlier studies demonstrated an increased incidence of adenocarcinomas of the gastric cardia of 4% to 10% per year from the mid-1970s to the late 1980s.[ ] Similarly, the incidence of gastroesophageal junction adenocarcinomas increased sharply, from 1.22 cases per 100,000 individuals (1973–1978) to 2.00 cases per 100,000 individuals (1985–1990).[ ] Since that time, the incidence has remained steady at 1.94 cases per

2012 PDQ - NCI's Comprehensive Cancer Database

109. Lymphoma, Adult Hodgkin

of . Early favorable group: Clinical stage I or II without any of the adverse prognostic factors listed above. Early unfavorable group: Clinical stage I or II with one or more of the adverse prognostic factors listed above. Advanced-stage adverse prognostic factors: For patients with advanced-stage HL, the International Prognostic Factors Project on Advanced Hodgkin's Disease developed the International Prognostic Index with a score that is based on the following seven adverse prognostic factors (...) a previous infection with the Epstein-Barr virus in the teenage years or early childhood. Having a first-degree relative with HL. Clinical Features These and other signs and symptoms may be caused by adult HL or by other conditions: Painless, swollen lymph nodes in the neck, axilla, or inguinal area. Fever defined as 38ºC or higher. Drenching and recurrent night sweats. Weight loss of 10% or more of baseline weight in the previous 6 months. Pruritus, especially after bathing or after ingesting alcohol

2012 PDQ - NCI's Comprehensive Cancer Database

110. Breast Cancer

cancer.) Screening Clinical trials have established that screening asymptomatic women using mammography, with or without clinical breast examination, decreases breast cancer mortality. (Refer to the PDQ summary on for more information.) Diagnosis Patient evaluation When breast cancer is suspected, patient management generally includes the following: Confirmation of the diagnosis. Evaluation of the stage of disease. Selection of therapy. The following tests and procedures are used to diagnose breast (...) cancer: Mammography. Ultrasound. Breast magnetic resonance imaging (MRI), if clinically indicated. Biopsy. Contralateral disease Pathologically, breast cancer can be a multicentric and bilateral disease. Bilateral disease is somewhat more common in patients with infiltrating lobular carcinoma. At 10 years after diagnosis, the risk of a primary breast cancer in the contralateral breast ranges from 3% to 10%, although endocrine therapy decreases that risk.[ - ] The development of a contralateral breast

2012 PDQ - NCI's Comprehensive Cancer Database

111. Oral Complications of Chemotherapy and Head/Neck Radiation

-up = 0.7% Epidemiological studies = 1.2% Dysgeusia [ ] CT only = 56.3% (mean) RT only = 66.5% (mean) Combined CT and RT = 76% (mean) Oral fungal infection [ ] Of clinical oral fungal infection (all oral candidiasis): Pretreatment = 7.5% During treatment = 39.1% Posttreatment = 32.6% Of oral candidiasis clinical infection by cancer treatment: During HNC RT = 37.4% During CT = 38% Oral viral infection [ ] In patients treated with CT for hematologic malignancies: Patients with oral ulcerations (...) a setting in which novel classes of chemotherapeutic drugs, used at increased doses, could lead to enhanced cancer cure rates and durability of disease remission. As has been , it is essential that a multidisciplinary approach be used for oral management of the cancer patient before, during, and after cancer treatment. This collaboration is pivotally important for the advancement of basic, clinical, and translational research associated with oral complications of current and emerging cancer therapies

2012 PDQ - NCI's Comprehensive Cancer Database

112. Lonquex - lipegfilgrastim

Electrochemiluminescence E. Coli Escherichia coli ELISA Enzyme-linked immunosorbent assay EMA European Medicines Agency EMEA European Medicines Agency EORTC European Organisation for Research and Treatment of Cancer EU European Union FDA Food and Drug Administration FN Febrile neutropenia GCP Good clinical practice GGT Gamma-glutamyltransferase G-CSF Granulocyte colony stimulating factor GLP Good laboratory practice GM-CSF Granulocyte-Macrophage colony-stimulating factor hG-CSF human Granulocyte colony-stimulating (...) Products CI Confidence interval CL/f Total body clearance C max Maximum drug concentration in plasma/serum COPD Chronic obstructive pulmonary disease CPA Cyclophosphamide CPMP Committee for Proprietary Medicinal Products CRF Case report form CSR Clinical study report CTX Chemortherapy CV coefficient of variation DDL Drug dispensation log DIC Disseminated Intravascular Coagulopathy DSMB Data safety monitoring board DSN Duration of severe neutropenia DVT Deep vein thrombosis ECG Electrocardiogram ECL

2013 European Medicines Agency - EPARs

113. Istodax - romidepsin

Licensing status 7 1.2. Steps taken for the assessment of the product 8 1.3. Steps taken for the re-examination procedure 9 2. Scientific discussion 10 2.1. Introduction 10 2.2. Quality aspects 12 Manufacture 13 Specification 13 Stability 14 Pharmaceutical Development 14 Adventitious agents 15 Manufacture of the product 15 Product specification 16 Stability of the product 16 2.3. Non-clinical aspects 19 Primary pharmacodynamic studies 19 Secondary pharmacodynamic studies 24 Safety pharmacology programme (...) 24 Pharmacodynamic drug interactions 26 Single dose toxicity 28 Repeat dose toxicity 29 Genotoxicity 34 Carcinogenicity 34 Reproduction Toxicity 34 Toxicokinetic data 35 Local Tolerance 35 Other toxicity studies 35 2.4. Clinical aspects 43 GCP 43 Absorption 45 Distribution 45 Elimination 46 Dose proportionality and time dependencies 46 Special populations 46 Pharmacokinetic interaction studies 46 Pharmacokinetics using human biomaterials 47 Mechanism of action 47 Primary and Secondary

2013 European Medicines Agency - EPARs

114. Bosulif (bosutinib (as monohydrate))

and biological aspects 15 2.3. Non-clinical aspects 16 2.3.1. Introduction 16 2.3.2. Pharmacology 16 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 18 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 30 2.4. Clinical aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 35 2.4.3. Pharmacodynamics 40 2.4.4. Discussion on clinical pharmacology 41 2.4.5. Conclusions on clinical pharmacology 43 2.5. Clinical efficacy (...) 43 2.5.1. Dose response studies 44 2.5.2. Main studies 45 Supportive studies 56 2.5.3. Discussion on clinical efficacy 60 2.5.4. Conclusions on the clinical efficacy 64 2.6. Clinical safety 65 2.6.1. Discussion on clinical safety 75 2.6.2. Conclusions on the clinical safety 78 2.7. Pharmacovigilance 78 2.8. User consultation 81 3. Benefit-Risk Balance 81 4. Recommendations 85 Bosulif CHMP assessment report Page 3/87 List of abbreviations AE adverse event ALT aspartate aminotransferase AP

2013 European Medicines Agency - EPARs

115. Xtandi - enzalutamide

Bono, 2010). This intravenous chemotherapy is complicated by febrile neutropenia, neutropenic deaths, and serious gastrointestinal side effects including diarrhoea. Recently, abiraterone acetate, an oral inhibitor of androgen biosynthesis, has been approved for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel after demonstrating a 3.9-month survival advantage over placebo (de Bono, 2011). Treatment with abiraterone acetate requires the co (...) . Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 Pharmacodynamic drug interactions 22 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 23 Single dose toxicity 23 Repeat dose toxicity 24 Genotoxicity 26 Carcinogenicity 26 Reproduction Toxicity 26 Toxicokinetic data 27 Local Tolerance 27 Other toxicity studies 27 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 32 2.4. Clinical aspects 32

2013 European Medicines Agency - EPARs

116. Perjeta - pertuzumab

) although the proportion of patients with severe or life-threatening febrile neutropenia and diarrhoea was higher in the pertuzumab group compared to the placebo group. Adverse events resulting in death were observed in 2.5% of patients in the placebo arm and in 2.0% of patients in the pertuzumab arm. In terms of balance of benefits and risks, the totality of data indicated that pertuzumab was associated with clinically and statistically significant benefits in a patient population with limited (...) Target Range CR Complete response CRC Cardiac Review Committee CrCL Creatinine clearance CRO Clinical Research Organization CTD Common Technical Document CYP450 Cytochrome P450 DDI Drug-drug interactions DMA Danish Medicines Agency EBC Early breast cancer ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group ECLA Electrochemiluminescence assay ELISA Enzyme-linked Immunosorbent Assay EMA European Medicines Agency FACT-TOI-PFB Functional Assessment of Cancer Therapy – Trial Outcome Index

2013 European Medicines Agency - EPARs

117. Septic Shock (Follow-up)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine.com

118. Granulocytopenia (Diagnosis)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

119. Lymphoma, Mantle Cell (Diagnosis)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

120. Septic Shock (Treatment)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine.com

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