Haines IE. Dose selection in phase I studies: why we should always go for the Most effective. J Clin Oncol. 2008;26(21):3650–2.
Article
Google Scholar
Sleijfer S, Wiemer E. Dose selection in phase I studies: why we should always go for the top. J Clin Oncol. 2008;26(10):1576–8.
Article
Google Scholar
Postel-Vinay S, Gomez-Roca C, Molife LR, Anghan B, Levy A, Judson I, et al. Phase I trials of molecularly targeted agents: should we pay more attention to late toxicities? J Clin Oncol. 2011;29(13):1728–35.
Article
Google Scholar
Verweij J, Disis ML, Cannistra SA. Phase I studies of drug combinations. J Clin Oncol. 2010;28(30):4545–6.
Article
Google Scholar
Fromme EK, Eilers KM, Mori M, Hsieh Y-C, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the quality-of-life questionnaire C30. J Clin Oncol. 2004;22(17):3485–90.
Article
Google Scholar
Paoletti X, Le Tourneau C, Verweij J, Siu LL, Seymour L, Postel-Vinay S, et al. Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: results of a DLT-TARGETT international survey. Eur J Cancer. 2014;50(12):2050–6 Available from: https://doi.org/10.1016/j.ejca.2014.04.030.
Article
CAS
Google Scholar
Henon C, Lissa D, Paoletti X, Thibault C, Le TC, Lanoy E, et al. Patient-reported tolerability of adverse events in phase 1 trials. ESMO Open. 2017;2(2):e000148.
Article
Google Scholar
Ringash J, Lockwood G, O’Sullivan B, Warde P, Bayley A, Cummings B, et al. Hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: quality of life in a prospective phase I/II trial. Radiother Oncol. 2008;87(2):181–7.
Article
Google Scholar
Tsubata Y, Okimoto T, Miura K, Karino F, Iwamoto S, Tada M, et al. Phase I clinical and pharmacokinetic study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly patients with advanced non-small cell lung cancer. Anticancer Res. 2013;33(1):261–6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23267154.
CAS
PubMed
Google Scholar
Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, et al. Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JNCI J Natl Cancer Inst. 2014;106(9):dju244.
Article
Google Scholar
Anota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil J-P, Minello A, et al. An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma. BMJ Open. 2016;6(6):e010696.
Article
Google Scholar
Bonnetain F, Fiteni F, Efficace F, Anota A. Statistical challenges in the analysis of health-related quality of life in Cancer clinical trials. J Clin Oncol. 2016 Jun;34(16):1953–6.
Article
Google Scholar
Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, et al. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol. 2016;17(11):e510–4.
Article
Google Scholar
Crew KD, Brown P, Greenlee H, Bevers TB, Arun B, Hudis C, et al. Phase IB randomized, double-blinded, placebo-controlled, dose escalation study of polyphenon E in women with hormone receptor-negative breast cancer. Cancer Prev Res. 2012;5(9):1144–54.
Article
CAS
Google Scholar
Xiao Z-Y, Jia J-B, Chen L, Zou W, Chen X-P. Phase I clinical trial of continuous infusion of tyroserleutide in patients with advanced hepatocellular carcinoma. Med Oncol. 2012;29(3):1850–8.
Article
CAS
Google Scholar
Lin NU, Freedman RA, Ramakrishna N, Younger J, Storniolo AM, Bellon JR, et al. A phase i study of lapatinib with whole brain radiotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Breast Cancer Res Treat. 2013;142(2):405–14.
Article
CAS
Google Scholar
Kanai M, Otsuka Y, Otsuka K, Sato M, Nishimura T, Mori Y, et al. A phase i study investigating the safety and pharmacokinetics of highly bioavailable curcumin (Theracurmin??) in cancer patients. Cancer Chemother Pharmacol. 2013;71(6):1521–30.
Article
CAS
Google Scholar
Han CH, Khwaounjoo P, Kilfoyle DH, Hill A, McKeage MJ. Phase I drug-interaction study of effects of calcium and magnesium infusions on oxaliplatin pharmacokinetics and acute neurotoxicity in colorectal cancer patients. BMC Cancer. 2013;13(1):495.
Article
Google Scholar
Rouanne M, Massard C, Hollebecque A, Rousseau V, Varga A, Gazzah A, et al. Evaluation of sexuality, health-related quality-of-life and depression in advanced cancer patients: a prospective study in a phase i clinical trial unit of predominantly targeted anticancer drugs. Eur J Cancer. 2013;49(2):431–8.
Article
CAS
Google Scholar
Stephenson CM, Levin RD, Spector T, Lis CG. Phase i clinical trial to evaluate the safety, tolerability, and pharmacokinetics of high-dose intravenous ascorbic acid in patients with advanced cancer. Cancer Chemother Pharmacol. 2013;72(1):139–46.
Article
CAS
Google Scholar
Hunn MK, Bauer E, Wood CE, Gasser O, Dzhelali M, Ancelet LR, et al. Dendritic cell vaccination combined with temozolomide retreatment: results of a phase I trial in patients with recurrent glioblastoma multiforme. J Neuro-Oncol. 2015;121(2):319–29.
Article
CAS
Google Scholar
Reiss KA, Herman JM, Zahurak M, Brade A, Dawson LA, Scardina A, et al. A phase I study of Veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy in patients with advanced solid malignancies and peritoneal Carcinomatosis. Clin Cancer Res. 2015;21(1):68–76.
Article
CAS
Google Scholar
Cusi MG, Botta C, Pastina P, Rossetti MG, Dreassi E, Guidelli GM, et al. Phase I trial of thymidylate synthase poly-epitope peptide (TSPP) vaccine in advanced cancer patients. Cancer Immunol Immunother. 2015;64(9):1159–73.
Article
CAS
Google Scholar
McRee AJ, Sanoff HK, Carlson C, Ivanova A, O’Neil BH. A phase i trial of mFOLFOX6 combined with the oral PI3K inhibitor BKM120 in patients with advanced refractory solid tumors. Investig New Drugs. 2015;33(6):1225–31.
Article
CAS
Google Scholar
Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, et al. Magnetic resonance imaging–guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate Cancer: a prospective phase 1 clinical trial. Eur Urol. 2016;70(3):447–55.
Article
Google Scholar