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An Investigation of the Mass Balance, Pharmacokinetics, Excretion and Metabolism of [14C]-Nanatinostat in Patients with Advanced Solid Tumors: A Phase 1, Open-Label Study

Primary objective:• To assess the mass balance of nanatinostat (ie, evaluate clearance mechanisms of nanatinostat and drug-related metabolites) following a single oral dose of [14C]-nanatinostat in patients with advanced cancer.Secondary objectives…

POINTING: Towards patient-tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging.

Primary objective:To compose multifaceted predictive signatures for PD-1 or anti-PD-L1 antibody effects with relevant components of integrative omics (histology, immunohistochemistry, genomics, transcriptomics, proteomics, radiomics and molecular…

A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)

Primary objective:To determine the MTD/recommended dose for further study of oral LOXO-292 in patients with advanced solid tumors, including RET-fusion NSCLC, MTC, and other tumors with increased RET activity.Secondary objectives:* To determine the…

A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study with Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients with Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway

Primary ObjectivesThe primary objectives of this study are:Phase I, Part A - Dose Escalation:• To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CB-103 as a single agent when administered orally and with repeat…

Combining drug-eluting bead transarterial chemoembolisation and radioembolization for treatment of colorectal liver metastases: DEBIR90Y study

This study has been transitioned to CTIS with ID 2024-514767-26-00 check the CTIS register for the current data. To find the maximum tolerated dose of glass yttrium-90 (90Y) microspheres (TheraSphere®), when combined with DEBIRI in patients with…

Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (formerly known as CB-1158) as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors

Primary ObjectivesParts 2To evaluate the safety and tolerability of INCB001158 for patients with advanced/metastatic and/or treatment-refractory solid tumorsParts 3To evaluate the safety and tolerability of INCB001158 in combination with…

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors

Part A - CX-2009 Monotherapy: Every 21-Day Dosing RegimenThe primary objective of Part A is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the dose-limiting toxicities(DLTs) of CX-…

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.

To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.

Determination of new biomarkers in patients with resectable colorectal liver metastases, the MIRACLE study

To establish (i) whether or not pre-operative determination of cell-free DNA (cfDNA) and circulating tumor cells (CTC), alone or in combination with each other, in peripheral blood of CRC patients with isolated colorectal liver metastases (CRLM)…

Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.

Optimisation of research protocols for respiratory challenges with the RespirAct (RA-MR)TM in healthy volunteers

Optimisation of MRI research protocols including respiratory challenges with the RespirActTM.

Applicability and effectiveness of a brief psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) adapted to Dutch cancer care settings

This study aims to 1. Assess the feasibility to implement CALM in a Dutch setting of a specialized oncology hospital, a university hospital and a psycho-oncology centre2. Research its preliminary effectiveness in these settings. 3. Explore the…

Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy.

To determine the safety, feasibility, and tolerability of adding PIPAC with oxaliplatin (92 mg/m2) to systemic chemotherapy in patients with isolated PM from CRC.

A Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination with Anticancer Agents including Pembrolizumab in Subjects with Selected Advanced Solid Tumors

OX40 agonists have been shown to increase antitumor immunity and improve tumor-free survival in non-clinical models and OX40 agonist monoclonal antibodies (mAbs) are currently being evaluated in Phase I clinical trials. GSK3174998 is a humanized…

Phase I/II study with the combination of afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancer

Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone.

The primary objective of this research is to compare the efficacy of continuing treatment with enzalutamide after adding docetaxel and prednisolone versus placebo plus docetaxel and prednisolone, as measured by progression-free survival (PFS) in…

MR-guided biopsy of liver metastases in patients with suspected pancreatic cancer

To obtain histopathology from liver lesions, visible on MRI but which cannot be biopsied with transabdominal ultrasound, using MR-guided biopsy.

Sentinel lymph node detection in patients with stage Ib-III melanoma using MultiSpectral Optoacoustic Tomotraphy (MSOT) and IndoCyanine Green (ICG)

Study the concordance rate of SLN identified using MSOT and ICG versus the standard of care with Tc99m and lymphoscintigraphic imaging.

Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of
pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer

The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and…

A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody* Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
(PROCLAIM-CX-072-002)

Part A:* To obtain evidence of antitumor effect of CX-072 in combination with ipilimumab in subjects withsolid tumors based on the objective response rate (ORR) as defined by the Response EvaluationCriteria in Solid Tumours (RECIST) v1.1Part B:* To…