20 results match your criteria include investigator-assessed

  • Page 1 of 1

Osimertinib Maintenance After Definitive Chemoradiation in Patients With Unresectable EGFR Mutation Positive Stage III Non-small-cell Lung Cancer: LAURA Trial in Progress.

Clin Lung Cancer 2021 Jan 6. Epub 2021 Jan 6.

Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA.

The LAURA trial (NCT03521154) will evaluate the efficacy and safety of osimertinib as maintenance therapy in patients with locally advanced, unresectable, epidermal growth factor receptor mutation-positive (EGFRm), stage III non-small-cell lung cancer (NSCLC) without disease progression during/following definitive platinum-based chemoradiation therapy (CRT). Eligible patients include adults aged ≥ 18 years (≥ 20 years in Japan) with locally advanced, unresectable, stage III NSCLC with local/central confirmation of an EGFR exon 19 deletion/L858R mutation. Patients must have received ≥ 2 cycles of concurrent/sequential platinum-based CRT, have no investigator-assessed progression, and have creatinine < 1. Read More

View Article and Full-Text PDF
January 2021

GEMSTONE-301: a phase III clinical trial of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who did not have disease progression after prior concurrent/sequential chemoradiotherapy.

Transl Lung Cancer Res 2020 Oct;9(5):2008-2015

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.

Background: In China, platinum-based doublet chemotherapy is the standard treatment for patients who have unresectable stage III non-small cell lung cancer (NSCLC), administered with radiotherapy on either a concurrent or sequential basis. However, NSCLC patients who undergo this treatment can expect poor median progression-free survival (PFS) of around 8-10 months and a dismal 5-year overall survival (OS) rate of about 15%. In the recent PACIFIC trial, durvalumab was demonstrated to hold significant clinical benefit for patients with locally advanced/unresectable NSCLC who experienced no disease progression after definitive concurrent chemoradiotherapy (cCRT). Read More

View Article and Full-Text PDF
October 2020

A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial.

Trials 2020 Feb 10;21(1):158. Epub 2020 Feb 10.

Imperial Clinical Trials Unit, Imperial College London, W12 7RH, London, UK.

Background: Current treatment options for Palmoplantar Pustulosis (PPP), a debilitating chronic skin disease which affects the hands and feet, are limited. The Anakinra for Pustular psoriasis: Response in a Controlled Trial (APRICOT) aims to determine the efficacy of anakinra in the treatment of PPP. This article describes the statistical analysis plan for the final analysis of this two-staged trial, which was determined prior to unblinding and database lock. Read More

View Article and Full-Text PDF
February 2020

Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline mutations: OPINION Phase IIIb study design.

Future Oncol 2019 Nov 25;15(32):3651-3663. Epub 2019 Sep 25.

Biometrics & Information Sciences, AstraZeneca, Cambridge, CB2 8PA, UK.

The poly(ADP-ribose) polymerase inhibitor olaparib (Lynparza™) is approved for maintenance treatment of platinum-sensitive relapsed ovarian cancer. OPINION is a single-arm, open-label, multicenter, Phase IIIb study to assess the efficacy and safety of olaparib tablet maintenance therapy in women with high-grade serous or endometrioid platinum-sensitive relapsed ovarian cancer without a germline or mutation. Eligible patients should have received ≥2 prior lines of platinum-based chemotherapy and be in complete or partial response following their most recent course or have no evidence of disease. Read More

View Article and Full-Text PDF
November 2019

Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial.

Lancet Oncol 2019 05 1;20(5):636-648. Epub 2019 Apr 1.

Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St Joseph's Hospital, Phoenix, AZ, USA.

Background: Late-line treatment options for patients with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10%, and median overall survival after third-line therapy of 5-9 months. In this study (QUADRA), we investigated the activity of niraparib monotherapy as the fourth or later line of therapy.

Methods: QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens. Read More

View Article and Full-Text PDF

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.

Breast Cancer Res Treat 2019 Apr 10;174(3):719-729. Epub 2019 Jan 10.

Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA, USA.

Purpose: In the initial PALOMA-2 (NCT01740427) analysis with median follow-up of 23 months, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) [hazard ratio (HR) 0.58; P < 0.001]. Read More

View Article and Full-Text PDF

Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Int J Gynecol Cancer 2019 Jan 10. Epub 2019 Jan 10.

IRCCS National Cancer Institute "Fondazione G. Pascale" Naples, Napoli, Italy.

Background: There is mounting pre-clinical and clinical evidence that combinations of immunotherapy, specifically programed cell death-1 (PD-1) inhibition, with chemotherapy and anti-angiogenesis agents, such as bevacizumab, result in markedly improved outcomes across a variety of tumor types including endometrial cancer, renal cell cancer, and non-small cell lung cancer. IMagyn050/GOG 3015/ENGOT-OV39 is the first, randomized, phase III trial to evaluate the potential impact of this combination on both progression-free survival and overall survival in patients presenting with advanced epithelial ovarian cancer.

Primary Objective: The primary objective is to evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel + carboplatin + bevacizumab for front-line treatment of ovarian cancer among all patients and those with PD-L1+ tumors. Read More

View Article and Full-Text PDF
January 2019

A randomized, open-label, Phase III trial of pertuzumab retreatment in HER2-positive locally advanced/metastatic breast cancer patients previously treated with pertuzumab, trastuzumab and chemotherapy: the Japan Breast Cancer Research Group-M05 PRECIOUS study.

Jpn J Clin Oncol 2018 Sep;48(9):855-859

The Cancer Institute Hospital of JFCR, Breast Oncology Center, Tokyo, Japan.

The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label Phase III study to determine if retreatment with pertuzumab is more effective than conventional treatment in HER2-positive locally advanced (LA)/metastatic breast cancer (MBC) patients previously treated with pertuzumab, trastuzumab and chemotherapy. Patients are randomized 1:1 into chemotherapy plus trastuzumab with or without pertuzumab groups. The latest regimen before enrollment did not include pertuzumab, and the number of previous chemotherapy regimens for LA/MBC did not exceed three. Read More

View Article and Full-Text PDF
September 2018

Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia.

N Engl J Med 2018 Mar;378(12):1107-1120

From the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and University of Melbourne, Melbourne, VIC (J.F.S.), and the John Curtin School of Medical Research, Australian National University, Canberra, ACT (J.D.) - all in Australia; the University of California School of Medicine, San Diego (T.J.K.), and Genentech, South San Francisco (E.A.P., Y.L., M. Mobasher) - both in California; University Hospital Cologne and the Center for Integrated Oncology Cologne-Bonn, Cologne, Germany (B.E.); St. James's University Hospital, Leeds (P.H.), and F. Hoffmann-La Roche, Welwyn Garden City (M.B., K.H.) - both in the United Kingdom; Segal Cancer Center, Lady Davis Institute, Jewish General Hospital, Montreal (S.A.), and the Departments of Medicine and Oncology, University of Calgary, Calgary, AB (C.O.) - all in Canada; Memorial Sloan Kettering Cancer Center, New York (J.G.); the Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland (T.R.); Hospital Universitario 12 de Octubre, Madrid (J.D.S.); Medical University of Vienna, Department of Medicine I, Division of Hematology and Hemostaseology, Vienna (U.J.); the Department of Hematology, Centre Hospitalier Universitaire Montpellier, Montpellier, France (G.C.); the Department of Onco-Hematology, Division of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan (M. Montillo); AbbVie, North Chicago, IL (R.H.); and the Department of Hematology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam (A.P.K.).

Background: Venetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.

Methods: In this randomized, open-label, phase 3 trial, we randomly assigned 389 patients to receive venetoclax for up to 2 years (from day 1 of cycle 1) plus rituximab for the first 6 months (venetoclax-rituximab group) or bendamustine plus rituximab for 6 months (bendamustine-rituximab group). Read More

View Article and Full-Text PDF

SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer.

Ann Oncol 2017 Dec;28(12):3028-3036

Lowe Center for Thoracic Oncology and The Belfer Institute for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, USA.

Background: Combination of selumetinib plus docetaxel provided clinical benefit in a previous phase II trial for patients with KRAS-mutant advanced non-small-cell lung cancer (NSCLC). The phase II SELECT-2 trial investigated safety and efficacy of selumetinib plus docetaxel for patients with advanced or metastatic NSCLC.

Patients And Methods: Patients who had disease progression after first-line anti-cancer therapy were randomized (2 : 2 : 1) to selumetinib 75 mg b. Read More

View Article and Full-Text PDF
December 2017

A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices.

NPJ Prim Care Respir Med 2016 11 24;26:16079. Epub 2016 Nov 24.

Respiratory Medical Franchise, GSK, Brentford, UK.

Errors in the use of different inhalers were investigated in patients naive to the devices under investigation in a multicentre, single-visit, randomised, open-label, cross-over study. Patients with chronic obstructive pulmonary disease (COPD) or asthma were assigned to ELLIPTA vs DISKUS (Accuhaler), metered-dose inhaler (MDI) or Turbuhaler. Patients with COPD were also assigned to ELLIPTA vs Handihaler or Breezhaler. Read More

View Article and Full-Text PDF
November 2016

HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer.

BMC Cancer 2016 06 3;16:352. Epub 2016 Jun 3.

Sarah Cannon Research Institute, and Tennessee Oncology, PLLC, Nashville, TN, USA.

Background: Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a particularly aggressive form of the disease, and ultimately progresses in patients with metastases on standard therapies. Anthracyclines, such as doxorubicin, are an effective treatment for HER2-positive breast cancer, particularly when administered in combination with trastuzumab - however, doxorubicin-related cardiotoxicity has limited its use. Many patients are therefore never treated with anthracyclines, even upon disease progression, despite the potential for benefit. Read More

View Article and Full-Text PDF

BEVERLY: Rationale and Design of a Randomized Open-Label Phase III Trial Comparing Bevacizumab Plus Erlotinib Versus Erlotinib Alone as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous Non-Small-Cell Lung Cancer.

Clin Lung Cancer 2016 09 22;17(5):461-465. Epub 2016 Apr 22.

Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy.

Background: About 20% of advanced non-small-cell lung cancer (NSCLC) cases harbor somatic mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR) gene. In these patients, the standard first-line treatments are the EGFR-tyrosine kinase inhibitors, such as gefitinib, erlotinib, or afatinib. Most of these patients develop resistance and relapse within about 1 year of initiation of an EGFR-tyrosine kinase inhibitor. Read More

View Article and Full-Text PDF
September 2016

Interventions for acne scars.

Cochrane Database Syst Rev 2016 Apr 3;4:CD011946. Epub 2016 Apr 3.

Department of Dermatology, Faculty of Medicine, Cairo University, 13th Abrag Othman, Kournish el Maadi, Cairo, Egypt, 11431.

Background: Acne scarring is a frequent complication of acne and resulting scars may negatively impact on an affected person's psychosocial and physical well-being. Although a wide range of interventions have been proposed, there is a lack of high-quality evidence on treatments for acne scars to better inform patients and their healthcare providers about the most effective and safe methods of managing this condition. This review aimed to examine treatments for atrophic and hypertrophic acne scars, but we have concentrated on facial atrophic scarring. Read More

View Article and Full-Text PDF

Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial.

Trials 2015 Dec 16;16:575. Epub 2015 Dec 16.

Breast Center, University of Munich, Munich, Germany.

Background: Triple-negative breast cancer is an aggressive disease with unmet clinical needs. In a phase III study of patients with metastatic triple-negative breast cancer, first-line gemcitabine/carboplatin resulted in a median progression-free survival of 4.6 months. Read More

View Article and Full-Text PDF
December 2015

Anti-TNF agents for paediatric psoriasis.

Cochrane Database Syst Rev 2015 Nov 24(11):CD010017. Epub 2015 Nov 24.

Grupo de Investigación Dermatológica (GRID), Universidad de Antioquia, Carrera 25 A #1 A Sur 45, Of 733, Torre Medica El Tesoro, Medellín, Colombia.

Background: Psoriasis is a chronic skin disease that may develop at any age. Estimates for the United States and Europe suggest that psoriasis accounts for 4% of skin diseases in children. In most cases, the condition is mild and can be treated with creams. Read More

View Article and Full-Text PDF
November 2015

First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study.

Ann Oncol 2015 Sep 23;26(9):1883-1889. Epub 2015 Jun 23.

Roche (China) Holding Ltd, Shanghai, China.

Background: The phase III, randomized, open-label ENSURE study (NCT01342965) evaluated first-line erlotinib versus gemcitabine/cisplatin (GP) in patients from China, Malaysia and the Philippines with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).

Patients And Methods: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. Read More

View Article and Full-Text PDF
September 2015

Drug development in oncology: a regulatory perspective.

Stella Augustus

Am J Ther 2011 Jul;18(4):323-31

F. Hoffmann-La Roche, Basel, Switzerland.

The ultimate goal of any drug development, including that in oncology, is to register the new medicinal product. A number of challenges remain in this field, primarily in demonstrating the efficacy of the new oncology products to the satisfaction of the regulatory authorities worldwide. Key aspects of clinical trial design, conduct, and analysis that require careful consideration by the sponsors before initiation of drug development programs in oncology include the choice of primary and secondary end points, the choice of comparators, the necessity for independent radiologic review of a disease-related end point such as progression-free survival and tumor response, and the relative value of the independently reviewed and investigator-assessed clinical end points. Read More

View Article and Full-Text PDF

Laser-assisted liposuction using a novel blend of lipid- and water-selective wavelengths.

Lasers Surg Med 2009 Dec;41(10):760-6

Maryland Laser Skin and Vein Institute, Hunt Valley, MD21030, USA.

Background And Objectives: Potential benefits of laser-assisted liposuction include enhanced body shaping and skin tightening with reduced patient downtime. In this clinical study, we investigate whether additional safety and efficacy are achieved with a diode laser system that includes a novel 924 nm lipid-selective wavelength.

Study Design/materials And Methods: Clinical subjects were treated with a continuous-wave (CW) power 924/975 nm diode laser system in the submental area, abdomen, thighs and flanks. Read More

View Article and Full-Text PDF
December 2009

Moisturizing cream ameliorates dryness and desquamation in participants not receiving topical psoriasis treatment.

Cutis 2008 Sep;82(3):211-6

Dermatology Consulting Services, High Point, North Carolina, USA.

Psoriasis is a disorder characterized by faster than normal skin growth, resulting in a buildup of thickened areas with a scaly appearance. Common sites of involvement include the scalp, elbows, knees, and back. Moisturization of these areas may provide relief by increasing hydration. Read More

View Article and Full-Text PDF
September 2008
  • Page 1 of 1