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An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)

Primary Objectives:- To evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with JAK 1/2 Inhibitor in combination with capecitabine versus capecitabine alone.Secondary…

S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines.

The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.

Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial

The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician*s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer;patients

Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…

The PLCRC substudy Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases - a proof of concept study

The primary objective of this feasibility/pilot study is to find the correct scanning protocol to assess 5FU drug trapping in colorectal cancer liver metastases using 7T MRS (phase 1). Secondary objectives will be assessed during phase 2 of this…

Proof of principle and pharmacological phase 0 crossover study with controlled release capecitabine (ModraCape001)

Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…

Neo-adjuvant chemotherapy, cytoreductive surgery with hypethermic intraperitoneal chemotherapy for peritoneal carcinomatosis of colorectal origin.

To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.

Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity in Patients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study)

Primary: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.

A double-blind, placebo-controlled, randomized, multicenter phase III study evaluating the efficacy and safety of pertuzumab in combination with trastuzumab and chemotherapy in patients with HER2-positive metastatic gastro-esophageal junction and gastric cancer

Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…

Phase I pharmacological study of continuous and intermittent chronomodulated capecitabine therapy

To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended dose (RD) of continuous and intermittent chronomodulated capecitabine.Secondary study objectives are:To determine plasma pharmacokinetics of capecitabine…

The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study

The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.

A Phase Ib/randomized phase II study of BEZ235 and trastuzumab versus lapatinib and capecitabine in patients with HER2-positive locally advanced or metastatic breast cancer who failed prior to trastuzumab.

PrimairTo determine the MTD and/or RP2D of oral twice daily (BID) BEZ235 in combination with trastuzumab in patients with HER2-positive breast cancerSecondairTo assess the preliminary activity of the combinationTo assess the safety and tolerability…

A pilot study evaluating response to induction chemotherapy with oxaliplatin, capecitabine and bevacizumab in patients with extensive peritoneal carcinomatosis of colorectal origin.

* The primary objective of this study is:- the study of the response rate and the macroscopic and microscopic response charactheristics of neo-adjuvant chemotherapy of patients with peritoneal carcinomatosis (PC) of colorectal origin. * Secundary…

Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination with Cisplatin and Capecitabine as First-Line Therapy in Patients with Inoperable Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

To establish the MaximumTolerated Dose, Dose Limiting Toxicities, and the safety profile of BMS-833923 administered in combination with cisplatin and capecitabine as first-line therapy. To describe preliminary evidence of tumor response as measured…

PHARMACOGENOMIC AND PHARMACOKINETIC SAFETY AND COST-SAVING ANALYSIS IN PATIENTS TREATED WITH FLUOROPYRIMIDINES

The primary objective of the study is to prospectively determine whether fluoropyrimidine-induced toxicity is preventable by dose adjustment prior to start of the first administration based on the polymorphic status of the DPYD*2A polymorphism in…

A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
An IKZ-based phase II feasibility study

This study investigates the feasibility role of neoadjuvant chemotherapy, consisting of docetaxel (Taxotere), cisplatin and capecitabine (Xeloda) (TCX), and protocolized surgery in localized and/or locally advanced resectable gastric cancer (D1extra…

The Breast CARE Study: Capecitabine (Xeloda) combined with Rhenium-188-HEDP in breast cancer patients with bone metastases; a Re-188-HEDP phase I dose escalation study and phase II efficacy study.

Phase IThe primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of Re-188-HEDP combined with Capecitabine.Phase IIThe primary aim of the phase II part of this study is to obtain…

The Prostate CARE Study: Capecitabine (Xeloda??) combined with Rhenium-188-HEDP in hormone refractory prostate cancer patients with bone metastases; a Capecitabine phase I dose escalation study and phase II efficacy study.

The primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of capecitabine combined with Re-188-HEDP.The primary aim of the phase II part of this study is to obtain insight in the…