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A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…

TRAILS - Tracking the next generation

The proposed study has 2 main aims: 1) Understanding the complex interplay of determinants of parenting and examining how specific parenting styles explain associations between parent characteristics (such as personality or mental and physical (ill…

Sentinel lymph node identification in colon and rectal cancer using a radioactive and fluorescent tracer

Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

Immune intervention with tolerogenic dendritic cells in type 1 diabetes. A phase 1 safety study called D-sense

Primary objectives- To evaluate the feasibility of leukapheresis and the production of human clinical-grade proinsulin-peptideC19-A3-pulsed TolDCs (PIpepTolDCs) in type 1 Diabetes Mellitus patients.- To evaluate the safety of clinical use of…

Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG)

To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…

PRospective Evaluation of interventional StudiEs on boNe meTastases

The PRESENT cohort has three goals: first, the cohort provides detailed, clinical information for example therapy response and quality of life and satisfaction with care, second, the PRESENT cohort provides a framework for multiple, concurrent,…

A Phase III double-blind placebo-controlled Randomized Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

This study has been transitioned to CTIS with ID 2022-502324-48-00 check the CTIS register for the current data. To study the effect of 80mg aspirin (given orally once daily for five years) on fiveyear overall survival (OS) for stage II and III…

A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma.

- To evaluate the treatment efficiency by time to progression according to RECIST 1.1