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Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial
This phase I/II trial characterized the tolerability, safety, and antitumor activities of unecritinib, a novel derivative of crizotinib and a...
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Phase I/II trial of BMS-986,205 and nivolumab as first line therapy in hepatocellular carcinoma
BackgroundIndoleamine-2,3-dioxygenase (IDO) helps orchestrate immune suppression and checkpoint inhibitor resistance in hepatocellular carcinoma...
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Phase I/II clinical trial of nivolumab in combination with oligo-fractionated irradiation for unresectable advanced or recurrent gastric cancer
BackgroundAlthough immune checkpoint inhibitors (ICI) targeting for PD-1 axis is a promising approach for advanced gastric cancer (GC) patients, the...
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In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I–II Clinical Trial
IntroductionThe aim of this work is to evaluate the effect of mesenchymal stem cell transplantation (MSCT) and cultivated limbal epithelial...
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Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies
IntroductionReCOV is a recombinant protein vaccine that aims to induce cross-neutralization against SARS-CoV-2 variants. The phase I and phase II...
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A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial
BackgroundBurn-related injuries are a major global health issue, causing 180,000 deaths per year. Early debridement of necrotic tissue in association...
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Phase I/II study of stereotactic body radiotherapy boost in patients with cervical cancer ineligible for intracavitary brachytherapy
PurposeStereotactic body radiotherapy (SBRT) boost is a promising treatment for cervical cancer patients who are ineligible for intracavitary...
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Neoadjuvant radiohormonal therapy for oligo-metastatic prostate cancer: safety and efficacy outcomes from an open-label, dose-escalation, single-center, phase I/II clinical trial
To evaluate the safety and efficacy of neoadjuvant radiohormonal therapy for oligometastatic prostate cancer (OMPC), we conducted a 3 + 3 dose...
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Oral minocycline for the treatment of retinitis pigmentosa–associated cystoid macular edema: results of a phase I/II clinical trial
PurposeThe etiology of retinitis pigmentosa (RP)–associated cystoid macular edema (CME) has been related to retinal neuroinflammation and microglial...
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Repurposing pantoprazole in combination with systemic therapy in advanced head and neck squamous cell carcinoma: a phase I/II randomized study
Pantoprazole decreases the acidity of the tumor microenvironment by inhibiting proton pumps on the cancer cell. This possibly leads to increased...
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Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial
Aim/hypothesisThis study aimed to investigate the safety and efficacy of treatment with allogeneic Wharton’s jelly-derived mesenchymal stromal cells...
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Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy—the MecMeth/NOA-24 trial
BackgroundGlioblastoma is the most frequent and malignant primary brain tumor. Even in the subgroup with O-6-methylguanine-DNA methyltransferase...
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A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant, and olanzapine for a cisplatin-containing regimen. - PATROL-I-
Dexamethasone is one of the key antiemetic agents and is widely used even now. However, dexamethasone has been associated with several adverse...
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A phase I/II study of LY3022855 with BRAF/MEK inhibition in patients with Melanoma
BRAF/MEK targeted therapies and immune checkpoint inhibition have dramatically improved disease control and survival of patients with advanced...
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Pazopanib with Topotecan weekly for patients with platinum-resistant or intermediate-sensitive recurrent ovarian cancer: results of a multicentre, open label phase I/II study (TOPAZ)
PurposePazopanib has promising antiangiogenetic activity in solid cancers. The investigator-initiated phase I/II trial evaluated the combination of...
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Präzisionsonkologie und Phase-I/II-Netzwerke in der Kinderkrebsmedizin
To enable rapid and efficient implementation of early clinical trials for pediatric patients and provide comprehensive access to novel treatment...
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Looking ahead in early-phase trial design to improve the drug development process: examples in oncology
BackgroundClinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example,...
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Interpreting a Bayesian phase II futility clinical trial
BackgroundA resurgence of research into phase II trial design in the mid-2000s led to the use of futility designs in a wide variety of disease areas....
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Phase I/II trial of ruxolitinib in combination with trastuzumab in metastatic HER2 positive breast cancer
PurposePreclinical data demonstrate STAT3 as an important regulator in HER2+ tumors, and disruption of the IL6-JAK2-STAT-S100A8/S100A9 signaling...
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A phase I/II study of MCS110 with BRAF/MEK inhibition in patients with melanoma after progression on BRAF/MEK inhibition
Background: Prognosis for patients with metastatic melanoma has been improved dramatically with the development of BRAF/MEK directed therapy and...
