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The landscape of cancer therapy has been transformed by advances in clinical next‐generation sequencing, genomically targeted therapies, and immunotherapies. Well designed clinical trials and efficient clinical trial conduct are crucial for advancing our understanding of cancer, improving patient outcomes, and identifying personalized treatments. Basket trials have emerged as one of the efficient...
Background
Infigratinib (BGJ398) is a potent and selective fibroblast grown factor receptor 1 to 3 (FGFR1‐3) inhibitor with significant activity in patients with advanced or metastatic urothelial carcinoma bearing FGFR3 alterations. Given the distinct biologic characteristics of upper tract urothelial carcinoma (UTUC) and urothelial carcinoma of the bladder (UCB), the authors examined whether infigratinib...
Background
In the phase 3 MARIANNE trial, trastuzumab emtansine (T‐DM1) with or without pertuzumab showed noninferior progression‐free survival and better tolerability than trastuzumab plus a taxane (HT) for the first‐line treatment of human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. This article reports the final descriptive overall survival (OS) analysis, updated...
BACKGROUND
This study compared the efficacy and safety of treatment with erlotinib plus pazopanib versus erlotinib plus placebo in patients with previously treated advanced non–small cell lung cancer (NSCLC).
METHODS
Patients with progressive‐stage IV NSCLC after either 1 or 2 previous chemotherapy regimens were randomized to receive erlotinib (150 mg by mouth daily) with either pazopanib (600...
BACKGROUND
The best treatment for patients with advanced non–small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single‐agent pemetrexed or 1 of 2 combination regimens.
METHODS
Patients with newly diagnosed, histologically confirmed nonsquamous NSCLC and an Eastern Cooperative Oncology...
BACKGROUNDThe current phase 1, open‐label, dose escalation study was conducted to establish the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of the novel mitochondrial inhibitor ME‐344 in patients with refractory solid tumors.
METHODSPatients with refractory solid tumors were treated in a 3 + 3 dose escalation design. ME‐344 was administered via intravenous infusion...
BACKGROUND:The randomized, controlled BOLERO‐2 (Breast Cancer Trials of Oral Everolimus) trial demonstrated significantly improved progression‐free survival with the use of everolimus plus exemestane (EVE + EXE) versus placebo plus exemestane (PBO + EXE) in patients with advanced breast cancer who developed disease progression after treatment with nonsteroidal aromatase inhibitors. This analysis investigated...
BACKGROUND:We conducted a phase 1, multicenter, open‐label, dose‐escalation study (TDM3569g) to assess the safety, tolerability, and pharmacokinetics of single‐agent trastuzumab emtansine (T‐DM1) administered weekly and once every 3 weeks in patients with HER2‐positive metastatic breast cancer previously treated with trastuzumab. The weekly dose results are described here.
METHODS:Patients were administered...
BACKGROUND:In this phase 2 study, the activity and tolerability of the combination of bevacizumab, an inhibitor of angiogenesis, and everolimus, an inhibitor of the mammalian target of rapamycin (mTOR), was evaluated in the treatment of patients with metastatic melanoma.
METHODS:Patients with metastatic melanoma who had received up to 2 previous systemic regimens (chemotherapy and/or immunotherapy)...
BACKGROUND:Despite the widespread use of oxaliplatin‐based regimens for colorectal and other gastrointestinal cancers, there is surprisingly little information regarding their empiric use for the treatment of carcinoma of unknown primary site (CUP). In the current study, the combination of oxaliplatin and capecitabine in patients with recurrent and refractory CUP was examined.
METHODS:Patients with...
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