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Clinical Index of Stable Febrile Neutropenia

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381. Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment (...) defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1 [ Time Frame: From Baseline up to end of study (assessed up to 55 months) ] CBR is defined as a confirmed CR, confirmed PR, or stable

2008 Clinical Trials

382. Study of Sorafenib and Infusional 5-Fluorouracil in Advanced Hepatocellular Carcinoma (HCC)

entry. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated, or at the discretion of the investigator; however, they may not be substituted for a required dose reduction. Chronic Erythropoietin treatment prior to the study entry or during the study is permitted. Use of ritonavir and grapefruit juice. Prior use of Raf-Kinase inhibitors, MEK or Farnesyl Transferase Inhibitors. Any investigational drug (...) administered as a single agent. Investigators reported seven patients with partial responses, five minor responses and 59 with stable disease for at least 4 months. Median overall survival was 9.2 months and median time to progression 4.2 months. This study showed that Sorafenib was well tolerated and side-effects were manageable and reversible. Rationale 5-Fluorouracil (5-FU) is a widely used agent for patients with unresectable advanced HCC, with objective responses rates around 10%. Compared to bolus

2008 Clinical Trials

383. The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

is currently enrolling. Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks. Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks. The maximum duration of the trial is one year of therapy. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 19 participants Intervention Model: Single Group Assignment Masking: None (Open (...) to Primary Outcome Measures : Number of Patients Free of Dose Limiting Toxicity [ Time Frame: 21 days ] A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria: Hematologic Toxicity: CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia

2006 Clinical Trials

384. Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Toxicities (DLTs) [ Time Frame: baseline through end of Phase 1 (up to 18 months) ] The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L). Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE (...) : Pemetrexed - Phase 1 Drug: Carboplatin - Phase 1 Drug: Pemetrexed - Phase 2 Drug: Carboplatin - Phase 2 Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 86 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent

2007 Clinical Trials

385. An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

1 up to Day 21 during Cycle 1 in schedule B ] MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 (...) : This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Bortezomib Drug: Dexamethasone Drug: PD 0332991 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 53 participants Allocation: Non

2007 Clinical Trials

386. HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349349 Sponsors and Collaborators GlaxoSmithKline Investigators Layout table for investigator information Study Director: GSK Clinical Trials GlaxoSmithKline More Information Go to Publications of Results: Other Publications: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT (...) Type : Interventional (Clinical Trial) Actual Enrollment : 223 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab Study Start Date : June 2006 Actual Primary Completion Date : May 2008 Actual

2006 Clinical Trials

387. LMB-2 to Treat Hairy Cell Leukemia

immunotoxin containing variable domains of MAb anti-Tac and truncated Pseudomonas exotoxin. A phase I trial at National Cancer Institute (NCI) found that the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (QOD x3). The most common adverse events were transient fever, hypoalbuminemia and transaminase elevations. In that trial, 4 of 4 patients with chemoresistant HCL had major responses, including one complete (CR) and 3 partial remissions (...) consolidation cycles, or 4 consolidation cycles if CR is with minimal residual disease. Dose level: LMB-2 40 microg/Kg QOD x3 Expected Accrual: 5-10 patients/year, total of 25 patients 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: A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for CD25

2006 Clinical Trials

388. Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer

-limiting Toxicities [ Time Frame: Cycle 1 (Days 1-28) ] A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: Grade 4 neutropenia lasting >3 days in the absence of growth factor support; Grade 4 neutropenia associated with fever >38.5°C; Any other Grade 4 hematological toxicity; Grade 3 thrombocytopenia with hemorrhage (...) -related activities. Exclusion Criteria: Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart). Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT). Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. Patient has known infection with human immunodeficiency

2006 Clinical Trials

389. A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent. Evidence of other clinically significant uncontrolled condition(s), including, but not limited to active systemic fungal infection; diagnosis of fever and neutropenia with in 1 week prior to study drug. Received steroid therapy with in 7 days prior to 1st dose of study drug for anti-neoplastic intent. Received any anti (...) and Sezary syndrome or other indolent B-cell lymphomas such as marginal zone lymphoma; Received at least 1 prior chemotherapy treatment regimen (P1a/1b) and relapsed or refractory disease (P2a). Eastern Cooperative Oncology Group (ECOG) score of <= 1. Magnetic Resonance Imaging (MRI)/computed tomography (CT) negative for subdural or epidural hematoma w/in 28 days prior to first dose, if clinically indicated. Stable dose of Selective serotonin reuptake inhibitors (SSRI) antidepressants for at least 21

2006 Clinical Trials

390. Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug (...) Response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) ] RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor

2007 Clinical Trials

391. Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors

Criteria Adverse Events (CTCAE), Version 3 [ Time Frame: Day 1 up to Day 21 of first cycle ] DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal (...) of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx

2007 Clinical Trials

392. 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

393. 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

394. 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

395. 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

396. A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

[ Time Frame: Week 96 ] A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional (...) point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Time to Disability Progression [ Time Frame: Baseline up to Week 96 ] Time to disability

2005 Clinical Trials

397. Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

as tolerated and disease under study does not worsen. Outcome Measures Go to Primary Outcome Measures : Number of Participants With Dose-limiting Toxicities (DLT) in Part 1 [ Time Frame: Part 1 Baseline up to Day 28 ] DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet (...) participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly

2005 Clinical Trials

398. Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present. Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [ Time Frame: From randomization to end of study drug therapy (up to 174 weeks). ] Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC (...) Recruitment Status : Completed First Posted : June 2, 2005 Results First Posted : October 5, 2010 Last Update Posted : December 24, 2015 Sponsor: Eli Lilly and Company Collaborator: ImClone LLC Information provided by (Responsible Party): Eli Lilly and Company Study Details Study Description Go to Brief Summary: The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than

2005 Clinical Trials

399. Neutropaenic Patients and Neutropaenic Regimes

. 2013 May21(5):1487-95. doi: 10.1007/s00520-013-1758-y. Epub 2013 Feb 27. ; Predicting febrile neutropenic patients at low risk using the MASCC score: does bacteremia matter? Support Care Cancer. 2011 Jul19(7):1001-8. Epub 2010 Jul 2. ; A survey of the management of neutropenic fever in oncology units in the UK. Int J Antimicrob Agents. 2007 Apr29(4):430-3. Epub 2007 Feb 12. ; NICE Clinical Guideline (September 2012) ; NICE Evidence Services (UK access only) ; G-CSF and GM-CSF in Neutropenia. J (...) neutropenia patients although its use in the UK is still low. [ ] These are patients who are haemodynamically stable, who do not have acute leukaemia or evidence of organ failure, and who do not have pneumonia, an indwelling venous catheter or severe soft tissue infection. Quinolone with amoxicillin plus clavulanic acid is the preferred choice given the rise in Gram-positive febrile neutropenia episodes. [ ] Oral quinolone therapy should not be used in patients who have taken a quinolone antibacterial

2008 Mentor

400. Systemic Lupus Erythematosus

Collaborating Clinic Index 2012 (SLICC'12) is more sensitive and may allow patients to be classified as having SLE earlier in the disease course. [ ] Investigations When SLE is suspected, useful screening investigations are urinalysis, FBC, ESR or plasma viscosity and antinuclear factor. : as initial test for proteinuria/haematuria. FBC and ESR: Mild normochromic normocytic anaemia is common. Anaemia in patients with lupus may be drug-induced or due to chronic disease, but it is sometimes due to haemolytic (...) , UK and European Guidelines. You may find the article more useful, or one of our other . In this article In This Article Systemic Lupus Erythematosus In this article Systemic lupus erythematosus (SLE) is a heterogeneous, inflammatory, multisystem autoimmune disease in which antinuclear antibodies occur (often years before clinical symptoms). [ ] Lupus erythematosus describes the typical rash of SLE and the term systemic emphasises the potential for multi-organ involvement. The cause of SLE

2008 Mentor

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