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MR-only workflow in radiotherapy for patients with prostate cancer and patients with rectal cancer.

Primary objective:To investigate whether MR-only radiotherapy in prostate and rectal cancer patients is at least non-inferior in terms of position verification performed by a registration between the pCT and CBCT instead of the CT.Secondary…

An Open-label, Phase I Study to determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, administered to Subjects with Advanced Stage and/or Refractory Solid Malignancies

Primary study objectives:· To determine the safety [(adverse event profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)] of JNJ-26483327in male and female subjects with cancer.· To determine the pharmacokinetics (PK) of JNJ-…

Phase II single-arm studies of gemcitabine in combination with oxaliplatin in refractory and relapsed pediatric solid tumors

To assess the response rate to the combination of gemcitabin plus oxlaiplatin in 5 different strata of relapsed/refractory pediatric solid tumors, in whom standard treatment has failed. Secondary objectives are the safety, the duration of response,…

The MR-Linac Technical Feasibility Protocol For Development of MR-guided Adaptive Radiation Therapy.

Primary: To test the feasibility of multiple techniques / software for MR-guided adaptive radiation therapy on the Elekta Unity MRL.Secondary: To register acute grade >= 3 toxicity.

IgA-based immunotherapy development and evaluation using the blood of healthy volunteers

The main objective of the study is to assess efficacy of engineered IgA antibodies (anti-EGFR, anti-EpCAM) in inducing specific tumor cell killing by myeloid immune effector cells. The secondary objectives of the study will be:-To evaluate relative…

A phase I/IIa open label study to assess the safety, tolerability, immunogenicity and clinical activity of EI-201 mRNA immunotherapy given intravenously in subjects with recurrent or metastatic HPV16 positive carcinoma

COHORT 1Primary objective: • To assess the safety and tolerability of IV administration of EI 201 as monotherapy in subjects with incurable R/M HPV16+ oropharyngeal and anogenital tumors and to select a starting dose of EI-201 for Cohort 2 Secondary…

A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors.

This study has been transitioned to CTIS with ID 2024-510984-52-00 check the CTIS register for the current data. Main Objective : - Dose escalation part: To determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination…

The food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®) using a stable isotopically labelled microtracer approach

To determine the food-effect of a standardised Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Cmax, AUC and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach.

A Phase 1a/1b Open label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

This study has been transitioned to CTIS with ID 2023-506285-31-00 check the CTIS register for the current data. This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 as a single agent (Phase Ia) or in…

A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies

Primary: Part 1: Safety and tolerability. Determine the MTD and/or RP2D of MAK683.Part 2: Anti-tumor activity of MAK683.Secondary: Part 1: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).Part 2: Safety and tolerability. PK, PD.

A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with atezolizumab or isatuximab alone in patients with advanced malignancies

Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…

A phase Ib dose-finding study of BYL719 plus everolimus and BYL719 plus everolimus plus exemestane in patients with advanced solid tumors, with dose-expansion cohorts in renal cell cancer (RCC), pancreatic neuroendocrine tumors (pNETs), and advanced breast cancer (BC) patients

MAIN OBJECTIVEDose escalation phase :- To determine the MTD and/or RDE of alpelisib (BYL719) in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestaneDose expansion part:- To describe safety…

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies

To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours

A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumours

Primary Objectives:* Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D, 200mg BID) of TAS-119.

A blind randomized multicenter study of accelerated fractionated chemo-radiotherapy with or without the hypoxic radiosensitizer nimorazole (Nimoral), using a 15 gene signature for hypoxia in the treatment of squamous cell carcinoma of the head and neck.

There are two primary objectives in this study: The first of them is to evaluate in a blinded randomized trial, whether the hypoxic cell radiosensitizer nimorazole can improve the effect of primary curative accelerated fractionated concomitant chemo…

A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignancies

Primary: To determine the maximum tolerated dose (MTD) and thus the recommended phase IIdose and schedule of single agent oral BGJ398 in patients with advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation.Secundary objectives* to…

Phase 1 study to evaluate the safety of REducing the prophylactic dose of DEXamethasone around docetaxel infusion in patients with early or advanced breast cancer and prostate cancer.

Primary: To determine the optimal dose/recommended dose (RD) of pre-medication dexamethasone around docetaxel infusion.Secondary: * Does a dose reduction of prophylactic dexamethasone around the docetaxel infusion decrease the body*s metabolic…

Sorafenib administered using a high-dose, pulsatile regimen in patients with advanced solid malignancies: a phase I exposure escalation study

Primary Objectives: - To determine the maximum tolerated plasma AUC0-12h of high-dose sorafenib administered in a weekly, pulsatile schedule.- To assess the safety and tolerability of high-dose, pulsatile sorafenib. Secondary Objectives:- To…

A phase 1, randomized, double blind, placebo-controlled, single and repeated ascending dose study to assess safety, tolerability and pharmacokinetics of ZW800-1 injected intravenously into healthy volunteers

Primary Objective- To determine safety and tolerability of a single dose of ZW800-1 in healthy volunteers.Secondary Objectives- To determine the pharmacokinetics of a single dose of ZW800-1 by measuring the fluorescence of blood and urine.- To…

Mass Balance Study of PM01183 (lurbinectedin) Administered as 1-hour Intravenous Infusion to Patients with Advanced Cancer

The present study is aimed at identifying the specific routes of PM01183 excretion and elimination following its administration to patients with advanced tumors. Also, the study design may allow the identification and quantification, if possible, of…