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Clinical Index of Stable Febrile Neutropenia

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341. MLN8237 in Adults With Nonhematological Malignancies, Followed by MLN8237 in Lung, Breast, Head and Neck or Gastroesophageal Malignancies

according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay (...) -Stage 1). An interim analysis will determine which tumor indications will proceed to enroll an additional 25 patients (Phase 2-Stage 2) to further evaluate Overall Response Rate (ORR) and other secondary endpoints. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 273 participants Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1 Dose

2010 Clinical Trials

342. Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days. Grade 4 neutropenia Febrile neutropenia Grade 4 thrombocytopenia Grade 3 thrombocytopenia associated with bleeding Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days. We are reporting the results of this endpoint as the number of DLTs per dose level. Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR (...) States, 63110 Sponsors and Collaborators Mayo Clinic Investigators Layout table for investigator information Study Chair: Shaji K. Kumar, M.D. Mayo Clinic Principal Investigator: Vivek Roy, M.D. Mayo Clinic More Information Go to Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Layout table for additonal information Responsible Party: Mayo Clinic ClinicalTrials.gov Identifier: Other Study ID Numbers: MMRC-020-021 NCI-2009-01535 ( Registry Identifier

2010 Clinical Trials

343. MLN8237 in Patients With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer

) ] The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any (...) 2 portion of the study: Alisertib 40 mg BID + Paclitaxel 60 mg/m^2 Paclitaxel 80 mg/m^2 This multi-center trial was conducted in the United States, Poland and France. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and who did not experience disease progression (PD) were followed off-treatment once every 8 weeks until the occurrence of 110 progression-free survival (PFS) events. Study Design Go to Layout table for study

2010 Clinical Trials

344. Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2

treatment dose until 1 month of follow up visit date, and every cycle according CTCAE v3.0 for study dose adjustment as per guidelines based on episodes of febrile neutropenia; grade 4 thrombocytopenia and/or bleeding; and any grade 3 or 4 non-hematologic toxicity except nausea/emesis. Safety evaluation for medical conditions, symptoms or signs, laboratory parameters as per protocol criteria, disregarding disease progression when unrelated drugs or any procedure of study. Progression free survival (...) First Posted : April 22, 2013 Last Update Posted : April 22, 2013 Sponsor: Instituto Nacional de Cancer, Brazil Collaborator: Eli Lilly and Company Information provided by (Responsible Party): Instituto Nacional de Cancer, Brazil Study Details Study Description Go to Brief Summary: Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients. Patient PS 2 proportion in population

2010 Clinical Trials

345. Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer

encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia > 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay > 2 weeks due to drug-related adverse effects. Phase II: Progression-Free Survival (PFS) Time [ Time Frame: From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years) ] PFS was defined as the time from randomization to the first (...) of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started. Phase II: Percentage of Subjects With Clinical Benefit [ Time Frame: Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years) ] Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST

2009 Clinical Trials

346. A Study of IMC-A12 in Advanced Solid Tumors

, probably, or possibly related to cixutumumab: Grade 4 neutropenia lasting > 7 days; Grade 4 anemia; Grade ≥ 3 thrombocytopenia; Grade ≥ 3 neutropenia associated with fever; Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality and Grade 3 hyperglycemia; Grade 4 hyperglycemia; and/or Grade 4 or uncontrollable hypertension. If three participants complete the first 6-week cycle (according to the definition outlined above) with no DLTs, dose escalation to Cohort 2 may proceed. If one DLT (...) brain or leptomeningeal metastases (participants who are clinically stable (no symptoms during the 4 weeks prior to enrollment) with an assessment that no further treatment (radiation, surgical excision, or administration of steroids) is required are permitted to enter the study) The participant has an uncontrolled intercurrent illness including, but not limited to: Thrombotic or hemorrhagic disorders Gross hemoptysis (approximately one-half a teaspoon) Ongoing or active infection requiring systemic

2009 Clinical Trials

347. BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

and ototoxicity) drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection drug related CTCAE Grade 4 thrombocytopenia drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C) Total Plasma Clearance After Intravascular Administration (CL) [ Time Frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion ] Total plasma clearance after intravascular administration (CL (...) of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin. Condition or disease Intervention/treatment Phase Neoplasms Drug: BI-6727 Drug: BI 6727 Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 61 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose

2009 Clinical Trials

348. MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

: Up to Day 28 (Cycle 1) ] The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle. DLTs were defined as: Grade 4 neutropenia or thrombocytopenia Febrile neutropenia Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment Serum transaminase > 20 * upper limit of normal (ULN) Serum transaminase > 5 * ULN for >= 7 days Delay of the start of cycle 2 by >7 days due to pomalidomide (...) for patients with relapsed and refractory multiple myeloma Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone Drug: Aspirin Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 259 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I/II Multicenter, Randomized, Open

2009 Clinical Trials

349. Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

days while subject was on optimal vigorous antidiarrheal therapy. [3] Grade 4 neutropenia lasting >3 days or Grade 3 or 4 neutropenia of any duration with sepsis or a fever >38.5C. [4] Platelet value less than or equal to 25,000/mm3 or bleeding requiring a platelet transfusion. [5] Delayed recovery from toxicity, which delayed rescheduled re-treatment for >3 weeks. [6] Inability to maintain the original dose during the first 28 days of treatment (at least 21 doses of neratinib and 2 doses of TEMSR (...) ), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical Benefit Rate [ Time Frame: From first dose date to progression/death or last tumor assessment, up to 30 months ] Percentage of subjects with a complete response, partial response, or stable disease >= 24 weeks

2009 Clinical Trials

350. Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer

With at Least One Dose Limiting Toxicity in Phase I [ Time Frame: 4 weeks from start of treatment, up to 2 years ] Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved (...) : This is a phase I, dose-escalation study of sorafenib tosylate followed by a phase II study. Patients receive oral sorafenib tosylate on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 46 participants Intervention

2009 Clinical Trials

351. Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)

3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT. Secondary Outcome Measures : Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 Weeks ] Changes in only the largest diameter (unidimensional measurement (...) . The safety of this combination will be studied in both phases. Condition or disease Intervention/treatment Phase Lung Cancer Non-Small Cell Lung Cancer Drug: Dasatinib Drug: Erlotinib Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 53 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase I-II Study of Dasatinib and Erlotinib in Non-Small

2009 Clinical Trials

352. A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer

thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (/= 3 except (...) using the Kaplan-Meier method. Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population [ Time Frame: Baseline until disease progression, recurrence or death (up to approximately 3 years) ] CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease

2009 Clinical Trials

353. Posaconazole (NoxafilR)

versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy." The treatment regimen is 200 mg PO TID for the duration of time that the patient is at risk. In clinical trials, the average duration was 80 days in patients with HSCT and GVHD, and the average duration was 29 days in patients with henlatologic malignancies and prolonged neutropenia from chen~otherapy. Absorption is enhanced by food, particularly fatty meals; therefore the CLINICAL (...) Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely in~munocon~promised, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chenlotherapy." The treatment regimen is 200 mg PO TID for the duration of time that the patient is at risk. In clinical trials, the average duration of posaconazole treatment was 80

2006 FDA - Drug Approval Package

354. Coartem (artemether/lumefantrine)

% of patients had moderate to severe renal impairment. The 28- day cure rate and Fever Clearance Time (FCT) was similar between the patients with all levels of renal impairment. It is unclear why the median Parasite Clearance Time (PCT) NDA 22-268 Addendum to clinical review of efficacy Coartem®, artemether/lumefantrine was shorter (24 hours vs. 36 hours)) in patients with severe renal impairment compared to patients with normal renal function. Table 2: Efficacy in Patients = 16 years old with Impaired (...) Concunctivitis 6 Constipation 10 Cough 78 Coughing 6 Diarrhea 31 Eosinophilia 13 Excessive crying 3 Fever 7 Fever due to malaria 4 Headache 6 Heat Rash 3 Helminthiasis 4 Hepatomegaly 27 Hyperreflexia 6 Hypothermia 6 Insomnia 11 Irritability 7 LRTI 5 Malaria 21 Mild anemia 4 Nausea 6 None 85 Oral Moniliasis 4 Otitis media 4 Pityriasis veriscolor 3 Rash 12 Rashes 3 Rhinitis 6 Rigors 4 Scabies 8 Skin rash 3 Splenomegaly 26 URTI 8 Vomiting 45 Clinical (Safety) Review Study CCOA566A2403 Ozlem Belen, MD, MPH Study

2008 FDA - Drug Approval Package

355. 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.

356. Invasive aspergillosis: is treatment with 'inexpensive' amphotericin B cost-saving if 'expensive' voriconazole is only used on demand

an investigation of the costs from multiple hospital locations and further assessment of specific patient groups (e.g. patients with febrile neutropenia or other immunosuppressed conditions, or patients of different ages). Source of funding None stated. Bibliographic details Garbino J, Schnetzler G, Roberts C. Invasive aspergillosis: is treatment with 'inexpensive' amphotericin B cost-saving if 'expensive' voriconazole is only used on demand. Swiss Medical Weekly 2006; 136(39-40): 624-630 PubMedID DOI Other (...) patients. J Antimicrob Chemother 2005;55:352-61. Bates DW, Su L, Yu DT, et al. Mortality and costs of acute renal failure associated with amphotericin B therapy. Clin Infect Ther 2001;132:301-2. Kaiser L, Huguenin T, Lew PD, et al. Invasive aspergillosis. Clinical features of 35 proven cases at a single institution. Medicine 1998;77:188-94. Indexing Status Subject indexing assigned by NLM MeSH Acute Kidney Injury /economics /etiology; Amphotericin B /adverse effects /economics /therapeutic use

2006 NHS Economic Evaluation Database.

357. Diagnosis and Treatment of Wilson Disease: An Update

perforans serpingosa • Serous retinitis • Hepatotoxicity Reduce dose for surgery to promote wound-healing and during pregnancy Maximum dose 20 mg/kg/day; reduce by 25% when clinically stable Trientine General chelator induces cupruria 10%-15% during initial phase of treatment • Gastritis • Aplastic anemia rare • Sideroblastic anemia Reduce dose for surgery to promote wound-healing and during pregnancy Maximum dose 20 mg/kg/day; reduce by 25% when clinically stable Zinc Metallothionein inducer, blocks (...) online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/hep.22261 Potential con?ict of interest: Nothing to report. 2089min protein without copper, apoceruloplasmin, result in the decreased blood level of ceruloplasmin found in most patientswithWDduetothereducedhalf-lifeofapoceru- loplasmin. 11 WD occurs worldwide with an average prevalence of 30 affected individuals per million population. 12 It can present clinically as liver disease, as a progressive neuro- logical disorder (hepatic

2008 American Association for the Study of Liver Diseases

358. EANM procedure guideline for radio-immunotherapy for B-cell lymphoma with 90Y-radiolabelled ibritumomab tiuxetan (Zevalin)

(NHL). II. Background Information and Definitions A. Definitions 1. Radio-immunotherapy (RIT) for relapsed or refractory CD20-positive B-cell NHL means intravenous administration of 90 yttrium [ 90 Y]-labelled ibritumomab tiuxetan (Zevalin ® ). 2. 90 Y(III)chloride is produced through decay of the radioactive precursor nuclide 90 strontium [ 90 Sr]. The decay of 90 Y is accompanied by the release of beta radiation with a maximum energy of 2.281 MeV (99.98%) into stable 90 zirconium [ 90 Zr (...) . Usually it is advised that therapy should not be performed if these values are above 2.5 times the upper normal limit of the local laboratory. 8. Estimation of life expectancy (life expectancy > 3 months, Karnofsky index > 70%). A patient with a life expectancy of less than 3-4 weeks is unlikely to benefit from treatment. Similarly, patients showing rapidly progressing disease are not candidates for RIT because of delayed efficacy of the treatment. 9. Probably due to methodological problems

2006 European Association of Nuclear Medicine

359. Cost-effectiveness analysis comparing liposomal anthracyclines in the treatment of AIDS-related Kaposi's sarcoma

trials, with variance in clinical and resource estimates of response rates (+/-10%), rates of growth factor use (+/-6%), costs of treatment of febrile neutropenia (an additional $300/responder) and dosage regimen. A comparison was also made using both higher dose and higher efficacy for liposomal daunorubicin and using an assumption of six cycles of treatment for both strategies. Estimated benefits used in the economic analysis Among severely immunocompromised patients with KS who received pegylated (...) of liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology 1998;16:683-691. Gill P S, Wernz J, Scadden D T, et al. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology 1996;14:2353-2364. Indexing Status Subject indexing assigned by NLM MeSH Acquired Immunodeficiency Syndrome /complications; Antibiotics, Antineoplastic

1998 NHS Economic Evaluation Database.

360. Cost-utility analysis of taxane therapy

duration of response was estimated to be six months, the disease being stable for three months and the one year mortality rate was assumed to be 57%. The response duration rates and mortality rates were assumed to be the same for both drugs. It was assumed that 25% of infections and incidents of febrile neutropenia would require hospitalisation. Measure of benefits used in the economic analysis The measure of benefits was Quality Adjusted Life Years (QALYs) gained. A Markov model was used to estimate (...) of effectiveness and key assumptions The frequency of adverse events associated with the use of paclitaxel or docetaxel respectively were as follows: infection, 23% and 26%; febrile neutropenia, 12.5% and 22%; death associated with infection and febrile neutropenia, 1.0% and 0.8%; severe neurotoxicity, 7% and 3.5%; severe fluid retention, 0% and 7%; and severe arthralgia, myalgia or skin reaction, 16% and 12%. The response rates for paclitaxel and docetaxel were found to be 21% and 47% respectively. The median

1997 NHS Economic Evaluation Database.

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