This phase I dose-escalation study is investigating the safety, tolerability and pharmacokinetics of BAY-1161909 in patients with advanced malignancies.
Provides information to potential participants on the following clinical trial: Phase I Dose-Escalation Study of Brutons Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, and the safety profile in patients with refractor
Taselisib was dosed in patients from 3 to 16 mg, administered once daily. One of 10 patients treated at 12 mg and 2 of 11 patients treated at 16 mg experienced AEs that qualified as DLTs. Although 16 mg did not exceed the MTD as defined by DLTs in cycle 1, no higher dose beyond 16 mg was tested based upon the overall tolerability of taselisib that included assessment of the frequency/severity of AEs outside of the DLT window. Patients treated at the higher doses (12-16 mg) experienced increased frequency of fatigue and hyperglycemia.. The overall AE profile for taselisib in the current study was largely consistent with other PI3K inhibitors (14-16). Buparlisib (BKM120), a pan-class inhibitor that targets all four isomers of PI3K, had rash, hyperglycemia, diarrhea, and mucositis as frequent treatment-related AEs (14). In-class toxicities for pictilisib, another pan-class PI3K inhibitor, included diarrhea, hyperglycemia, rash, and pneumonitis (15). Colitis observed with taselisib is similar to ...
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Sigma-Aldrich offers abstracts and full-text articles by [Jeffrey R Infante, E Claire Dees, Anthony J Olszanski, Shyeilla V Dhuria, Suman Sen, Scott Cameron, Roger B Cohen].
The goal of this clinical research study is to find the highest tolerable dose of PCI-32765 that can be given to patients with recurrent B-cell lymphoma.
This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part:. Dose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):. Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity.. Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients.. Once the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment.. Safety dose expansion part (advanced solid tumors, including patients with breast cancer being ...
TY - JOUR. T1 - Phase 1 trial of ontuxizumab (MORAb-004) in children with relapsed or refractory solid tumors. T2 - A report from the Childrens Oncology Group Phase 1 Pilot Consortium (ADVL1213). AU - Norris, Robin E.. AU - Fox, Elizabeth. AU - Reid, Joel M. AU - Ralya, Andrew. AU - Liu, Xiaowei W.. AU - Minard, Charles. AU - Weigel, Brenda J.. PY - 2018/1/1. Y1 - 2018/1/1. N2 - Background: Ontuxizumab is a humanized IgG monoclonal antibody that targets the cell-surface glycoprotein endosialin (tumor endothelial marker-1[TEM-1]/CD248) found on activated mesenchymal cells and certain tumors. Ontuxizumab binding to endosialin may interfere with platelet-derived growth factor signaling, prevent tumor stroma organization, and prevent new vessel formation. Methods: Ontuxizumab was administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle at three dose levels (4, 8, and 12 mg/kg). Further dose escalation to 16 mg/kg was planned if the maximum tolerated dose (MTD) was not reached and the ...
This phase I dose-finding study examined the effects of the combination of doxorubicin and docetaxel (Taxotere) in 42 women with metastatic breast cancer. The combination was studied at six different dosing levels. The maximum tolerated doses were defined as doxorubicin, 50 mg/m², and docetaxel, 85 mg/m², with sepsis as the dose-limiting toxicity. 1
Clinical Trials - clinicaltrials.gov This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor mali...
TY - JOUR. T1 - A phase 1, open label, dose escalation study to investigate the safety, tolerability, and pharmacokinetics of MG1102 (apolipoprotein(a) Kringle V) in patients with solid tumors. AU - Kim, Gun Min. AU - Reid, Tony. AU - Shin, Sang Joon. AU - Rha, Sun Young. AU - Ahn, Joong Bae. AU - Lee, Sung Sil. AU - Chung, Hyun Cheol. PY - 2017/12/1. Y1 - 2017/12/1. N2 - Purpose MG1102 is a potent inhibitor of angiogenesis in both in vitro and in vivo models. The purpose of the study was to investigate the safety and tolerability, pharmacokinetic (PK) profile, and preliminary antitumor efficacy of MG1102. Methods Patients with refractory solid tumors were eligible. Each patient received 1 dose of MG1102 followed by a 6-day rest period, during which they underwent PK assessments and safety monitoring. If the initial dose was tolerated, the patient continued with the 21-day treatment of MG1102 (5 days on, 2 days off for 3 weeks). Dose escalation was planned in 6 cohorts (6, 12, 24, 48, 96, and ...
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene. ...
A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors
This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations ...
Purpose: Ridaforolimus is an investigational, potent, selective mTOR inhibitor. This study was conducted to determine the recommended phase 2 dose (RP2D), maximum tolerated dose, safety, pharmacokinetics, and antitumor activity of oral ridaforolimus in children with advanced solid tumors. Experimental Design: In this phase 1, multicenter, open-label study in children aged 6 to , 18 years with advanced solid tumors, ridaforolimus was administered orally for 5 consecutive days/week in 28-day cycles until progression, unacceptable toxicity, or consent withdrawal. Dose started at 22 mg/m(2) and increased to 28 mg/m(2) and 33 mg/m(2), followed by expansion at the RP2D. Results: Twenty patients were treated; 18 were evaluable for dose-limiting toxicities. One dose-limiting toxicity (grade 3 increased alanine aminotransferase) occurred in 1 patient at 33 mg/m(2). Dose escalation concluded at 33 mg/m(2); the maximum tolerated dose was not determined. The most common treatmentrelated adverse events ...
Purpose: Foretinib is an oral multikinase inhibitor targeting Met, RON, Axl, and VEGFR. We conducted a phase I, first-time-in-human, clinical trial using escalating doses of oral foretinib. Primary objectives were to identify a maximum tolerated dose and determine the safety profile of foretinib. Secondary objectives included evaluation of plasma pharmacokinetics, long-term safety after repeated administration, preliminary antitumor activity, and pharmacodynamic activity. Experimental Design: Patients had histologically confirmed metastatic or unresectable solid tumors for which no standard measures existed. All patients received foretinib orally for 5 consecutive days every 14 days. Dose escalation followed a conventional "3+3" design. Results: Forty patients were treated in eight dose cohorts. The maximum tolerated dose was defined as 3.6 mg/kg, with a maximum administered dose of 4.5 mg/kg. Dose-limiting toxicities included grade 3 elevations in aspartate aminotransferase and lipase. ...
George Hallmey is the developer of this Fibonacci Retracement Fib & Click Grid Chart Overlay Software. Fibonacci Retracement is a concept that confuses many traders. But when it comes to trading forex, stocks, futures, commodities, options or whatever market you trade, fibonacci trading is one of the most important tool used by many pro traders in determining the likely turning points in the market.. Just like most traders, George as a new trader knew how the basic fibonacci retracement technique worked. You just need to observe the most recent high and low, determine two fib ratios of 38.2% and 61.8% and connect them with a couple of lines. But over the years, he learned that there was something more to this basic fib retracement technique. He learned fib trading using cycles, retracements, extensions, fans and arcs but still no clarity and no improvement in his trading results.. He went further and interviewed some of the best fibonacci traders and eventually learned those fib trading secrets ...
Atu027: Will dose escalation continue to pierce through the predicted efficacious dose?. Atu027 targets PKN3, a gene scientists at Silence Therapeutics first discovered to be involved in cancer-related processes downstream of the more widely recognized PI3K pathway (more on the background of Atu027 here). Although the precise mechanism remains somewhat unclear and could be relatively complex, as so often is the case in biology, various lines of evidence point towards an important role of PKN3 in the metastatic spread of tumor cells.. The phase I study of Atu027 to be presented at ASCO is an open-label, multi-dose dose escalation trial in patients with advanced solid tumors. Enrolment started at the end of 2009 at the low dose of 0.001mg/kg. This low starting dose was a consequence of this being the first human experience with the Atuplex delivery system and the known potential of cationic lipoplexes to stimulate various immune responses. The trial experience, however, suggests that this is not ...
Purpose:OSI-906 is a potent inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor (IR). The purpose of this study was to determine the maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, and preliminary activity of OSI-906 in patients with advanced solid tumors. Patients and Methods:This was a nonrandomized, open-label, phase I, dose-escalation study in patients with advanced solid tumors. The study also included a diabetic expansion cohort and a biomarker expansion cohort of patients with colorectal cancer. Patients were treated with OSI-906 by once- or twice-daily continuous dosing schedules. Results:Of 95 patients enrolled in the study, 86 received at least one dose of OSI-906. Dose-limiting toxicities (DLTs) included QTc prolongation, grade 2 abdominal pain and nausea, hyperglycemia and elevation of aspartate aminotransferase and alanine aminotransferase (all grade 3). The MTDs were established to be 400 mg once daily and 150 mg twice daily. ...
Home » Noncommunicable and/or Chronic Disease » Cancer/Oncology » Phase 1b, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, A Humanized 1gG1 Antibody in Combination with Bevacizumab with or without Paclitaxel in Patients with Locally Advanced or Metastatic Solid ...
Patients received LJM716 3-40 mg/kg QW and 20 mg/kg Q2W (54 patients; 36 patients at 40 mg/kg QW). No dose-limiting toxicities (DLTs) were reported during dose-escalation. One patient experienced two DLTs (diarrhea, hypokalemia [both grade 3]) in the expansion phase. The RDE was 40 mg/kg QW, providing drug levels above the preclinical minimum effective concentration. One patient with gastric cancer had an unconfirmed partial response; 17/54 patients had stable disease, two lasting ,30 weeks. Down-modulation of phospho-HER3 was observed in paired tumor samples ...
This study is a Phase I clinical trial of IPI-504 in combination with docetaxel (Taxotere).The purposes of the study are to determine: - the s
The family of fibroblast growth factors (FGFs) and FGF receptors (FGFRs) plays a critical role in cell proliferation and survival. A variety of genetic alterations (e.g. amplifications, mutations, and translocations) of these receptors and ligands have been found in diverse types of tumors. NVP-BGJ398 is a potent, selective, and orally bioavailable inhibitor of the FGFR tyrosine kinases. It inhibits the proliferation of various FGFR-dependent cell lines at nano-molar concentrations including breast and lung cancers harboring FGFR1 amplification, FGFR2-amplified gastric cancer cell lines and FGFR3-mutated bladder cancers. Objectives of the study: The purpose of this phase I-First In Human dose-escalation study is to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RPTD) of NVP-BGJ398 when administered orally to adult patients with advanced solid tumors. Secondary objectives include safety, tolerability, pharmacokinetics and preliminary anti-tumor activity in ...
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The goal of this clinical research study is to find the highest tolerable dose of QBI-139 that can be given to patients with solid tumors. The safety of this drug will also be studied.
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ClinicalTrials.gov summary of PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.
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Purpose The cell surface receptor tyrosine kinase c-Met and its ligand, hepatocyte growth factor (HGF), mediate cell migration, survival and proliferation. EMD 1214063 is a highly selective, reversible and ATP-competitive c-Met inhibitor that causes growth inhibition and regression of HGF-dependent and HGF-independent tumors in pre-clinical models.. Methods This is a first-in-man dose-escalation study to establish the MTD of EMD 1214063. Eligible pts had advanced solid tumors not amenable to standard therapy. Following a 3 + 3 dose escalation scheme, pts were treated with once-daily oral EMD 1214063 according to two 21-day-cycle schedules, either days 1-14 followed by a 7-day rest (regimen 1, [R1]), or continuous 3 times weekly (regimen 2, [R2]). An optimised formulation was introduced in August 2011. Pd markers were evaluated in paired tumor biopsies using immunohistochemistry (IHC) and a Luminex based assay.. Results Until 3 November 2011, 50 pts had been treated; 27 in R1 and 23 in R2. The ...
This general characteristic of eribulin mesylate places it in the group of drugs that includes Vinca alkaloids, dolastatins, and cryptophycin. However, its tubulin interactions appear to be unique.. The drug is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin mesylate demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype.. Finally, eribulin mesylate has been shown to decrease the migration and invasiveness of human breast cancer cells.. "We are excited to have initiated this Phase ( study and to transition MORAb-202 into the clinical development stage," ...
Clinical trial for Solid Tumor | Lymphoma | Malignant neoplasm of brain | Neuroblastoma , Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors CNS Tumors or Lymphoma
BACKGROUND Oral administration of irinotecan (CPT-11) should allow sustained exposure to the drug without the inconvenience of intravenous delivery and with fewer side-effects. PATIENTS AND METHODS The present phase I trial of CPT-11, administered orally as a powder-filled capsule for 5 consecutive days every 3 weeks at doses ranging from 30 to 90 mg/m(2)/day, was conducted in 47 patients for whom a satisfactory standard treatment option was no longer available (24 males/23 females; median age 51 years, range 26-85). Tumour types included melanoma (11), colorectal (4), urinary tract (3), lung/pleura (4), thyroid (3), liver (3), gallbladder (2), cervix/uterus (3), breast (2), pancreas (2), carcinoma and other cancer types (10). RESULTS A total of 171 cycles were administered (median 3, range 1-11). Dose limiting toxicities (DLTs) occurred during the first cycle in five of 31 patients in the dose-escalation part of the study: one patient at the 50 mg/m(2)/day dose level (diarrhoea grade 4); one
TY - JOUR. T1 - Phase I Trial of Intraperitoneal Docetaxel in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity. T2 - Dose-Limiting Toxicity and Pharmacokinetics. AU - Morgan, Robert J.. AU - Doroshow, James H.. AU - Synold, Timothy. AU - Lim, Dean. AU - Shibata, Stephen. AU - Margolin, Kim. AU - Schwarz, Roderich. AU - Leong, Lucille. AU - Somlo, George. AU - Twardowski, Przemyslaw. AU - Yen, Yun. AU - Chow, Warren. AU - Lin, Paul. AU - Paz, Benjamin. AU - Chu, David. AU - Frankel, Paul. AU - Stalter, Susan. PY - 2003/12/1. Y1 - 2003/12/1. N2 - Purpose: The purpose of this Phase I study was to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of i.p. docetaxel and to determine the peritoneal pharmacokinetics and pharmacological advantage of this agent. Experimental Design: Twenty-one patients with peritoneal carcinomatosis received docetaxel administered via an implanted i.p. catheter at doses of 40, 80, 100, 125, or 156 mg/m2 every 3 ...
In finance, Fibonacci retracement is a method of technical analysis for determining support and resistance levels. They are named after their use of the Fibonacci sequence. Fibonacci retracement is based on the idea that markets will retrace a predictable portion of a move, after which they will continue to move in the original direction. The appearance of retracement can be ascribed to ordinary price volatility as described by Burton Malkiel, a Princeton economist in his book A Random Walk Down Wall Street, who found no reliable predictions in technical analysis methods taken as a whole. Malkiel argues that asset prices typically exhibit signs of random walk and that one cannot consistently outperform market averages. Fibonacci retracement is created by taking two extreme points on a chart and dividing the vertical distance by the key Fibonacci ratios. 0.0% is considered to be the start of the retracement, while 100.0% is a complete reversal to the original part of the move. Once these levels ...
2-Deoxyglucose (2-DG), a glycolytic inhibitor analog of glucose, is widely investigated in experimental and clinical oncology for targeting glucose metabolism. Inhibition of the glycolytic pathway with 2-deoxyglucose leads to sensitization of tumor cells to other apoptotic stimuli(Maschek, G., et al Cancer Res. 64: 31-34, 2004). A phase I/II clinical trial of 2-DG for the treatment of advanced solid tumors and hormone refractory prostrate cancer has been initiated. One of the objectives of this dose escalation trial was to evaluate PK of 2-DG. The drug was administered orally on a daily schedule for 2 weeks of every 3 week cycle. The standard dose escalation format was followed with a starting dose 30mg/kg, escalated to 45mg/kg and 60mg/kg. So far twelve patients have been accrued for this trial (mean age, 65.4± 9.9 yrs), and all completed the study. Repeated oral administration of 2-DG was well tolerated, with a maximum tolerated dose (MTD) not exceeding 60mg/kg consecutive-day dosing. For the ...
A Phase I Open-label Dose-escalation Study to Evaluate the Safety of Intramuscular Injections of PLX-R18 Cells in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell ...
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Background and rationale: AS703569 is a novel, orally administered, potent ATP‐competitive, small molecule inhibiting aurora kinase A, B, and C as well as other kinases involved in cell proliferation and survival, including FLT3, ABL1, ABL1 (mut. T315I), JAK‐2, and FGFR3. In cell lines and tumor xenograft models AS703569 as single agent and in combination with standard‐of‐care anticancer agents has demonstrated strong inhibition of proliferation and induction of apoptosis leading to tumor regression and prolongation of animal survival.. Methods: This is an open label, phase I, dose‐escalation study with the objective to determine the MTD of 2 regimens (R) of AS703569 in patients (pts) with advanced solid tumors. In R1 AS703569 is given once daily (QD) day 1 and 8 and in R2 QD day 1, 2, 3 every 21 days (q21d). The dose escalation followed a 3+3 design, separate for each R; pts were assigned to either one of the 2 R sequentially. Dose escalation was stopped when at least 2/3 or 6 pts ...
Our objective is to design, construct and evaluate an RASV delivering multiple protective pneumococcal protein antigens to be delivered orally to newborns and infants to confer protective immunity to all pneumococcal serotypes. The vaccine prototype has been demonstrated to be totally safe in newborn, pregnant, malnourished and immunodeficient mice and the collective preclinical data led to FDA approval and the granting of an IND license. Human clinical dose escalation trials with doses up to 1010 CFU have been completed with no adverse reactions, essentially no bacteremias and no shedding of viable vaccine cells in stools. Although totally safe, the RASV constructs were not as immunogenic as desired but strains with the RpoS+ phenotype gave better results than the vaccine strain that was RpoS-. A selected strain has been further improved to significantly enhance immunogenicity without compromising safety attributes. This isolate will be evaluated in human trials. The vaccine is also designed to ...
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