Showing papers by "Michael Bass published in 2010"

The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research.

Abstract: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed as one of the first projects funded by the NIH Roadmap for Medical Research Initiative to re-engineer the clinical research enterprise. The primary goal of PROMIS is to build item banks and short forms that measure key health outcome domains that are manifested in a variety of chronic diseases which could be used as a "common currency" across research projects. To date, item banks, short forms and computerized adaptive tests (CAT) have been developed for 13 domains with relevance to pediatric and adult subjects. To enable easy delivery of these new instruments, PROMIS built a web-based resource (Assessment Center) for administering CATs and other self-report data, tracking item and instrument development, monitoring accrual, managing data, and storing statistical analysis results. Assessment Center can also be used to deliver custom researcher developed content, and has numerous features that support both simple and complicated accrual designs (branching, multiple arms, multiple time points, etc.). This paper provides an overview of the development of the PROMIS item banks and details Assessment Center functionality.

Phase 1 Study of AMG 386, a Selective Angiopoietin 1/2-Neutralizing Peptibody, in Combination with Chemotherapy in Adults with Advanced Solid Tumors

Abstract: Purpose: To evaluate the safety, pharmacokinetics, and antitumor activity of AMG 386, an investigational selective angiopoietin 1/2-neutralizing peptibody, in combination with FOLFOX-4 (F), carboplatin/paclitaxel (C/P), or docetaxel (D), in adult patients with advanced solid tumors. Experimental Design: Three cohorts of patients (F, n = 6; C/P, n = 8; D, n = 12) received one full cycle of chemotherapy alone during the pretreatment phase, followed by administration of AMG 386 10 mg/kg i.v. weekly in combination with chemotherapy until disease progression or intolerance. Safety and tolerability, tumor response, pharmacokinetic profiles, and biomarkers were assessed. Results: Twenty-six patients were enrolled; 22 received treatment with AMG 386. No dose-limiting toxicities or grade 3 or 4 adverse events related to AMG 386 were reported. The most common adverse events were diarrhea and hypomagnesemia ( n = 3 each). One patient developed grade 2 hypertension and one had grade 1 subconjunctival eye hemorrhage. No neutralizing antibodies to AMG 386 were detected. There were no pharmacokinetic interactions between AMG 386 and F, C/P, or D. One patient receiving AMG 386 plus C/P for bladder cancer refractory to gemcitabine/cisplatin had a complete response at week 8. The remaining best tumor responses were partial response ( n = 3, one from each cohort), stable disease ≥8 weeks ( n = 13), and progressive disease ( n = 1). Conclusions: Weekly administration of AMG 386 in combination with three common chemotherapy regimens was well tolerated in patients with advanced solid tumors. No pharmacokinetic interactions between AMG 386 and any of the tested chemotherapy regimens were noted. Promising antitumor activity was observed with all three treatment combinations. Clin Cancer Res; 16(11); 3044–56. ©2010 AACR.

Biomarkers as Predictors of Response to Treatment with Motesanib in Patients with Progressive Advanced Thyroid Cancer

Abstract: Context: Antiangiogenic therapies have shown potential in the treatment of advanced thyroid cancer, but it is uncertain which patients are most likely to benefit from therapy. Objective: This prespecified exploratory analysis investigated whether baseline levels and/or changes in circulating biomarkers could predict tumor response and/or progression-free survival (PFS) among patients enrolled in a phase 2 study of motesanib in advanced thyroid cancer. Design/Setting/Patients: Patients with progressive locally advanced or metastatic medullary or differentiated thyroid cancer received motesanib 125 mg once daily for up to 48 wk in a phase 2 interventional study. Samples for assessment of circulating biomarkers of angiogenesis or apoptosis were collected at study wk 1 (baseline), 2, 4, 8, 16, 24, 32, 40, 48, and 4 wk after cessation of motesanib treatment. Tumor response was assessed per Response Evaluation Criteria in Solid Tumors by independent review. Results: Change from baseline in serum placental growt...

Scalable side-pumped, gain-guided index-antiguided fiber laser

Abstract: Single-mode laser action has been demonstrated in a gain-guided, index-antiguided (GG IAG) Nd3+ doped phosphate glass fiber through the use of a diode side-pumping scheme. This pump technique can allow for length scaling of diode-pumped GG IAG fibers and therefore true power scaling of the GG IAG concept. Near-Gaussian beam quality was demonstrated with beam M2 of 1.4.

Phase 1 study of the investigational, oral angiogenesis inhibitor motesanib in Japanese patients with advanced solid tumors

Abstract: The aim of this study was to investigate the safety and pharmacokinetics of motesanib (AMG 706), a small-molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptor, and c-Kit in Japanese patients with advanced solid tumors. Patients were administered motesanib orally once daily (QD) at doses of 50, 100, and 125 mg QD. The total study duration for each patient consisted of three cycles of 28 days per cycle. The primary endpoints were the incidence of dose-limiting toxicities (DLTs), estimation of the maximum tolerated dose (MTD), and assessment of pharmacokinetic parameters of motesanib. Fifteen patients were enrolled and received motesanib. No DLTs were observed and, therefore, the MTD was not reached. Motesanib had acceptable toxicity at doses up to 125 mg QD. The pharmacokinetics of motesanib appears to be dose proportional. No objective responses per RECIST were observed. However, all 15 patients achieved stable disease, and five patients had durable (>24 weeks) stable disease. The results of this study demonstrate that motesanib is tolerable in Japanese patients at doses up to 125 mg QD.

Composite cavity for enhanced efficiency of up-conversion

Abstract: Methods, apparatus and systems for an up-converter resonant cavity light emitting diode device includes a semiconductor light source, an up-converter to form the light emitter with up-converting materials and an electrical source coupled with the semiconductor light source for providing electrical energy to the semiconductor light source to provide a desired wavelength emitted light. The semiconductor light source is a resonant cavity light emitting diode or laser that emits an approximately 975 mm wavelength to provide electrical and optical confinement to the semiconductor light source to form a resonant cavity up-converting light emitting diode (UC/RCLED). Rows and columns of electrodes provide active matrix addressing of plural sets of UC/RCLEDs for display devices. The up-converter resonant cavity light emitting diode device has applications in head mounted projection display optical system using spectrally selective beam splitters to eliminate spectral overlap between colors and to combine the red, green and blue beams.

Placental growth factor as a marker of therapeutic response to treatment with motesanib in patients with progressive advanced thyroid cancer, advanced nonsquamous non-small cell lung cancer, and locally recurrent or advanced metastatic breast cancer.

Abstract: 3037^ Background: We evaluated the effects of motesanib, an orally administered small-molecule antagonist of VEGF receptors 1, 2, and 3; PDGFR; and Kit, on angiogenic biomarkers among patients enro...

Diode Side Pumping of a Gain Guided, Index Anti-Guided Large Mode Area Neodymium Fiber Laser

Abstract: Diode side pumping of a gain guided, index anti-guided neodymium doped fiber laser is demonstrated. This method of pumping may lead to a scalable approach to create high power, extremely large mode area fiber lasers.

Biomarkers as potential predictors of response to treatment with motesanib or bevacizumab in combination with paclitaxel (P) in patients (pts) with locally recurrent or advanced metastatic breast cancer (MBC).

Abstract: 1048^ Background: Motesanib is an orally administered small-molecule antagonist of VEGF receptors (VEGFRs) 1, 2, and 3; PDGFR; and Kit. In a phase II study, objective response rates (per RECIST) of...

Emissive fibers containing up converters excited by GaAs based semiconductor light sources

Abstract: Methods and systems for an emissive fiber capable of being used for making emissive fabric by providing an optical fiber having a core and and embedding up conversion particles into at least one of the cladding and core to produce an emissive fiber that emits visible light when excited by light from near infrared light source that excites the up conversion particles. The optical fiber can have a core index of refraction that is greater than or less than the refractive index of the cladding for near infrared light or an index difference between the core and cladding of zero. Plural optical fibers are intertwined to produce an emissive fabric, wherein coupling a light source with the emissive fibers transmits a light beam through the fiber to excite the up conversion particles to emit visible light. The up conversion material can be embedded into the core, the cladding, or both.

Pump cavities for diode laser array pumped laser rods

Abstract: Systems, apparatus, devices and methods for pumping rod shaped solid state lasers with interchangeable arrays of diode laser pump sources that allows for rapid change of the diode laser array pump source without affecting or altering the solid state laser resonator. An embodiment includes a roof top structure having a light scattering reflection roof-top portion, sides with an interior specular reflecting surface and base opposite the top portion. The cavity includes a laser rod within the top portion of the structure positioned between opposing side walls, laser rod optics, and a pump source connected with the base plate to pump the laser rod. The pump cavity can include a mechanism for automating the rapid interchangeability of the pump source.