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A comprehensive and targeted therapy approach in pediatric malignant pontine gliomas

Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…

A multi-institutional open label, trial evaluating the efficacy of Gemcitabine and Docetaxel in patients with relapsed or refractory metastatic colorectal adenocarcinoma with methylated CHFR and/or microsatellite instability (MSI) phenotype.

Determine the efficacy of combination gemcitabine and docetaxel chemotherapy in the treatment of metastatic colorectal cancer with CHFR and/or MSI phenotype

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of;Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab;(IMC-11F8) in the First-Line Treatment of Patients With;Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…

Phase II trial of the combination of gemcitabine and 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma

To evaluate the efficacy and toxicity of gemcitabine in combination wth 131I-MIBG in pediatric patients with relapsed or progressive neuroblastoma.

PeRsOnalized treatment fOr patients with pleural eFfusions due to malignant pleural mesothelioma or lung cancer in second or third line. An open label phase II study (Acronym: the PROOF study)

The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.

Chemoradiation with gemcitabine in combination with panitumumab for patients with locally advanced pancreatic cancer.

Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.Phase II part 1) To investigate the proportion of patients…

Determination of the toxicity of standard dose cetuximab together with concurrent individualised, isotoxic accelerated radiotherapy and cisplatin - vinorelbine for patients with stage III non-small cell lung cancer (NSCLC): a phase I study.

To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.

Multicenter, randomized, open label study evaluating a poly(ADP-ribose) polymerase-1(PARP-1) inhibitor, SAR240550 (BSI-201), administered twice weekly or weekly, in combination with gemcitabine/carboplatin, in patients with metastatic Triple Negative Breast Cancer (mTNBC)

The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…

PHASE I-II STUDY OF GEMCITABINE AND VALPROIC ACID PLUS VALGANCICLOVIR IN PATIENTS WITH ADVANCED NASOPHARYNGEAL CARCINOMA

Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…

Phase I study of Gemcitabine plus Lapatinib (GW572016) in women with advanced breast cancer

Primary objective: To evaluate the safety of Gemcitabine and Lapatinib in combination for the treatment of advanced breast cancer.Secondary objectives: Assessment of the effect of Gemcitabine and Lapatinib on the pharmacokinetics of each other and…

A Phase I/II Study with NAMI-A a Novel Ruthenium Anticancer Agent, and Gemcitabine Combination Second-Line Therapy in NSCLC Patients

The primary objectives of the study are:- to establish the optimal dose of the combination for second-line therapy with NAMI-A and Gemcitabine (Phase I part)- to assess the response rate according to RECIST criteria (Phase II part) in advanced NSCLC…

Phase I study of gemcitabine and carboplatin plus sorafenib in patients with advanced solid tumors

primary • To determinne the safety and tolerability of sorafenib when administered in combination with gemcitabine and carboplatin.• To determine the maximal tolerated dose (MTD), dose limiting toxicity (DLT) and optimal treatment schedule of…

Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with locally advanced or metastasized pancreatic cancer

Phase ITo determine the toxicity and optimal dose of LDE225 when co-administered with fixed doses of gemcitabine and nab-paclitaxel in patients with advanced and metastasized pancreatic cancer.Phase IITo determine the anti-tumor activity of LDE225…

Phase 0 proof of concept study: a clinical pharmacokinetic microdosing trial with gemcitabine

To ascertain whether the pharmacokinetics of gemcitabine in a therapeutic dose can be predicted from the pharmacokinetics of a microdose.

OVACURE - Adoptive T cell therapy in recurrent ovarian cancer

Objectives: 1. The primary objective is to evaluate the safety and immune modulation of TIL plus IFN* in epithelial ovarian cancer (EOC) patients and to determine the optimal dose of IFN* that can be given in combination with chemotherapy.2.…

An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors.

Primary ObjectivesPart I- To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.Part II- To determine the safety and tolerability of…

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant
Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-
Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-
Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2024-512158-12-00 check the CTIS register for the current data. Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized…

Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (*URANUS*)

This study has been transitioned to CTIS with ID 2024-514991-41-01 check the CTIS register for the current data. To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based…

Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of tusamitamab ravtansine (SAR408701) monotherapy and in combination in patients with CEACAM5-positive advanced solid tumors

The purpose of this multi-cohort study is to assess the safety and efficacy of tusamitamab ravtansine (SAR408701) in mBC and mPAC participants with CEACAM5 positive tumors which are known to be sensitive to taxanes.

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma.

Primary:Phase 1: • To investigate the safety and tolerability, including identification of the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ZN-c3 in combination with gemcitabinePhase 2: • To evaluate the clinical activity of…