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Clinical Index of Stable Febrile Neutropenia

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321. Radiation Exposure and Contamination

days 7 days None None Overt illness Clinical manifestations Mild to moderate leukopenia Fatigue Weakness Moderate to severe leukopenia Purpura Hemorrhage Infections Epilation after 3 Gy Severe leukopenia High fever Diarrhea Vomiting Dizziness and disorientation Hypotension Electrolyte disturbance Nausea Vomiting Severe diarrhea High fever Electrolyte disturbance Shock N/A (patients die in 48 h) Dominant organ system syndrome Hematopoietic Hematopoietic GI (mucosal cells) GI (mucosal cells) CNS (...) of death. Management of the hematopoietic syndrome is similar to that of bone marrow hypoplasia and pancytopenia of any cause. Blood products should be transfused to treat anemia and thrombocytopenia, and hematopoietic growth factors (granulocyte colony-stimulating factor and granulocyte macrophage colony-stimulating factor) and broad-spectrum antibiotics should be given to treat neutropenia and neutropenic fever, respectively (see ). Patients with neutropenia should also be placed in reverse isolation

2013 Merck Manual (19th Edition)

322. A Phase 1/2 Study of the Oral ALK/EGFR Inhibitor AP26113

, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle. Cmax: Maximum (...) will be conducted worldwide. The overall expected time to participate in this study is approximately 4 years. Participants will make multiple visits to the clinic, and 30 days after the End-of-Treatment visit. Follow-up is intended to continue for at least 2 years after the initial dose. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 137 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open

2011 Clinical Trials

323. A Study of LY2584702 in Patients With Advanced Cancer

). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia (...) : Interventional (Clinical Trial) Actual Enrollment : 34 participants Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer Study Start Date : November 2008 Actual Primary Completion Date : April 2011 Actual Study Completion Date : April 2011 Arms and Interventions Go to Arm Intervention/treatment Experimental: LY2584702 Oral dose escalation starting at 25 milligrams (mg), daily

2011 Clinical Trials

324. Dasatinib In Combination With Trastuzumab And Paclitaxel In The First Line Treatment Of Her2-Positive Metastatic Breast Cancer (MBC) Patients

complicated with fever ≥38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment (...) . To evaluate the Clinical Benefit Rate (CBR) [ Time Frame: From treatment start until the date of first documented progression or date of death, whichever came first, assessed up to 100 months ] CBR is defined as the percentage of patients with a complete or partial response plus stable disease lasting at least 6 months out of the efficacy population. Time to Progression (TTP) [ Time Frame: From treatment start until the date of first documented progression or date of death, whichever came first, assessed

2011 Clinical Trials

325. A Safety Study in Patients With Advanced Solid Tumors

: Number of Participants With Dose-Limiting Toxicities Cycle 1 [ Time Frame: Baseline to Cycle 1 (Up to Day 28) ] A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 (...) Intervention/treatment Phase Advanced Solid Tumors Drug: Gemcitabine Drug: Docetaxel Drug: Temozolomide Drug: Cisplatin Drug: Erlotinib Drug: LY573636 Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 234 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1 Multicenter, Dose-escalation Study of LY573636-sodium in Combination

2011 Clinical Trials

326. A Study of LY2090314 in Patients With Advanced or Metastatic Cancer

criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of >5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval. Secondary Outcome (...) Cancer Drug: LY2090314 Drug: pemetrexed Drug: Carboplatin Other: ranitidine Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 41 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin Study Start Date : November 2007

2011 Clinical Trials

327. 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

328. A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)

Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at > grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue (...) response [Complete Response (CR), Unconfirmed Complete Response (CR(u)) or Partial Response (PR)] and determining best overall response of each patient. Phase 1 will enroll a maximum of 12 patients and Phase 2 will enroll up to approximately 40 patients Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 51 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title

2011 Clinical Trials

329. 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

330. 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

331. 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

332. 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

333. 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

334. Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer

with paclitaxel plus placebo. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial. The toxicity data from Study NCT00610714 (D8180C00015) suggests that a small number of patients could experience febrile neutropaenia during their first chemotherapy cycle. To combat this, saracatinib (175 mg OD)/matched placebo will begin 1 week prior to commencement of chemotherapy, and be given continuously until progression. All (...) patients will receive cycles of weekly paclitaxel chemotherapy. One cycle will consist of weekly paclitaxel (80 mg/m2) for 6 weeks followed by 2 weeks rest. If there is evidence of on-going response after 4 cycles, 3 further cycles of saracatinib/placebo plus weekly paclitaxel will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion

2010 Clinical Trials

335. Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea (...) Non-Small Cell Lung Cancer Drug: Ipilimumab, 3 mg Drug: Ipilimumab, 10 mg Drug: Paclitaxel Drug: Carboplatin Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 15 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase 1 Study of Ipilimumab (BMS-734016) in Combination With Paclitaxel and Carboplatin in Japanese Patients

2010 Clinical Trials

336. Phase 2/3 Study of IGSC, 20% in PIDD

(Clinical Trial) Actual Enrollment : 86 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD) Study Start Date : January 2013 Actual Primary Completion Date : March 2015 Actual Study Completion Date : March 2015 Resource (...) was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit. Secondary Outcome Measures : Annual Rate of All Infections Per Participant [ Time Frame: 1 year ] Annual Rate of Sinus Infections Per Participant [ Time Frame: 1 year ] Annual Rate of Fever Episodes Per Participant [ Time Frame: 1 year

2010 Clinical Trials

337. A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due (...) automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Layout table for additonal information Responsible Party: Merck Sharp & Dohme Corp. ClinicalTrials.gov Identifier: Other Study ID Numbers: 3415A-001 First Posted: November 16, 2010 Results First Posted: December 15, 2016 Last Update Posted: September 5, 2018 Last Verified: August 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: https://www.merck.com/clinical-trials/pdf

2010 Clinical Trials

338. An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours

With Dose Limiting Toxicities (DLT) [ Time Frame: 22 Days ] MTD was defined on the basis of DLTs occuring during Cycle 1 of the dose escalation part in each of the 2 treatment schedules. DLTs were defined as drug related based on Common Terminology Criteria for AE's (CTCAE) Grade(G) :1) G4 neutropenia (ANC, including bands, <500/mm³) for more than 7 days, 2) G3 or 4 neutropenia associated with fever >38.5° C (febrile neutropenia),3) Neutropenic infection G ≥3, 4) G4 thrombocytopenia or G3 (...) Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 57 participants Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment Official Title: An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBW 2992 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit Actual Study Start Date : October 4, 2010 Actual Primary Completion Date

2010 Clinical Trials

339. Effect of Anakinra on Insulin Sensitivity in Type 1 Diabetes Mellitus

Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Type 1 diabetes for more than 5 years Body mass index of > 25 kg/m2 Insulin requirement > 0.5 U/kg bodyweight HbA1c>7.5%, stable glycemic control Exclusion Criteria: Inability to give informed consent Presence of any medical condition that might interfere with the current study protocol. Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids) Anti-inflammatory drugs (...) effect of IL-1β blockade on insulin sensitivity, this study will test this hypothesis in subjects with type 1 diabetes and hence provide a proof of principle in vivo in humans for a proposed link between hyperglycemia, inflammation and insulin resistance. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 16 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official

2010 Clinical Trials

340. A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies

less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during (...) 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting

2010 Clinical Trials

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