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Neoplasm Malignant clinical trials

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NCT ID: NCT03775304 Completed - Quality of Life Clinical Trials

Evaluation of End of Life Quality of Care

EFIQUAVIE
Start date: January 1, 2011
Phase:
Study type: Observational

The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records. The study was approved by the French data protection authority (CNIL) number 611273.

NCT ID: NCT03667716 Active, not recruiting - Breast Cancer Clinical Trials

COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.

Start date: September 6, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.

NCT ID: NCT03491631 Active, not recruiting - Tumor, Solid Clinical Trials

Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors

Start date: November 20, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial is designed to efficiently identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) for the combination therapy regimen of the IDO1 inhibitor SHR9146 when administered in combination with immune checkpoint PD-1 inhibitor SHR-1210 plus VEGFR inhibitor Apatinib or not in subjects with advanced/metastatic solid tumors. All subjects will receive the same standard SHR-1210 plus Apatinib (only three drugs group)regimen, while SHR9146 in doses increasing from 100 mg twice daily to, potentially, 600 mg twice daily. Once the recommended regimen has been identified, subjects with the selected tumor type will be enrolled into expansion cohorts based upon prior safety and tolerability data.

NCT ID: NCT03324113 Completed - Neoplasm Malignant Clinical Trials

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

Start date: October 17, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective: - To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors. Secondary Objectives: - To characterize the overall safety profile of SAR408701 monotherapy. - To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites. - To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part. - To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity. - To assess the potential immunogenicity of SAR408701.

NCT ID: NCT03266185 Completed - Breast Cancer Clinical Trials

Shorter Scalp Cooling Time in Paclitaxel

COP
Start date: December 20, 2017
Phase: N/A
Study type: Interventional

Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients. Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in patients treated with taxanes, up to 80-90%. Previous research has shown comparable results of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an advantage for both the patient, who can spend less time in the hospital, as well for the logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes, that share similar mechanisms of action and have comparable plasma terminal half-life times, therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well.

NCT ID: NCT02575781 Completed - Neoplasm Malignant Clinical Trials

A Study of SAR428926 in Patients With Advanced Solid Tumors

Start date: October 5, 2015
Phase: Phase 1
Study type: Interventional

Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926 Secondary Objectives: To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites. To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients. To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).

NCT ID: NCT02435121 Completed - Neoplasm Malignant Clinical Trials

A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification

Start date: November 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine objective response rate (ORR). Secondary Objectives: To assess duration of response (DR), progression free survival (PFS) and overall survival (OS). To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplification. To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.

NCT ID: NCT02187848 Active, not recruiting - Neoplasm Malignant Clinical Trials

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Start date: July 23, 2014
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). - To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). - To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: - To characterize the overall safety profile of SAR408701. - To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. - To identify the recommended phase 2 dose (RP2D) of SAR408701. - To assess the potential immunogenicity of SAR408701.

NCT ID: NCT01985191 Completed - Neoplasm Malignant Clinical Trials

A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

Start date: November 2013
Phase: Phase 1
Study type: Interventional

Primary Objectives: To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors. To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors. Secondary Objectives: To characterize the pharmacokinetic profile of SAR405838 and pimasertib. To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib. To characterize genetic status in tumor tissue and circulating tumor DNA.

NCT ID: NCT01943838 Completed - Neoplasm Malignant Clinical Trials

A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma

Start date: October 2013
Phase: Phase 1
Study type: Interventional

Primary Objective: - To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma. Secondary Objectives: - To evaluate the pharmacodynamic (PD) effect of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma. - To explore the antitumor activity of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.