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203 results for

Clinical Index of Stable Febrile Neutropenia

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161. 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

162. 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

163. 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

164. 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

165. 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

166. 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

167. 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

168. 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

169. 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

170. 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

171. 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

172. 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

173. 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

174. 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

175. 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

176. 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

177. 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

178. 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 (...) , patients with renal impairment had similar 28-day cure rates to patients with normal baseline renal function. The degree of renal impairment at baseline may reflect more severe malaria with or without dehydration in these patients. In these studies, all patients with renal impairment cleared parasites within 48 hours and had similar clinical outcomes based on the 28-day cure rate to patients with normal renal function. Hepatic Impairment The applicant assessed patients in the clinical trials as having

2008 FDA - Drug Approval Package

179. 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

180. 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.

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