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Cancer clinical trials

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NCT ID: NCT02082977 Terminated - Cancer Clinical Trials

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

Start date: April 24, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.

NCT ID: NCT02082665 Completed - Cancer Clinical Trials

Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam

Start date: February 19, 2015
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib 150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily [BID]). Dabrafenib 150 mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23. Subjects will be considered to have completed the study once the 32 hour PK sample has been collected on Day 23. Once they have completed the study, eligible subjects may have the option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up visit required) and continue receiving dabrafenib.

NCT ID: NCT02078544 Recruiting - Cancer Clinical Trials

Integrated Molecular Analysis of Cancer (IMAC)

Start date: December 2013
Phase:
Study type: Observational

The purpose of the study is to identify biomarkers and potentially actionable mutations/ activated molecular pathways and evaluate the impact of molecular profiling information on patients with cancer. The hypothesis of the study are: - Analysis of tumour samples will allow us to identify novel and/or actionable molecular changes that may drive therapeutic strategies for the management of cancers. - Molecular profiling will improve the outcome of novel targeted-agent treatment in clinical trials - Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will provide new insights into mechanisms underlying drug resistance and metastasis in cancers.

NCT ID: NCT02078089 Terminated - Cancer Clinical Trials

Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

Start date: March 6, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary endpoints are improving pain control, reduce morphine use and improve the quality of life.

NCT ID: NCT02077621 Withdrawn - Cancer Clinical Trials

Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

Start date: February 2014
Phase: Phase 2
Study type: Interventional

PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in patients undergoing palliative abdominal surgery for cancer. The secondary endpoints, including the length of hospital stay, postoperative complications, HRQL, inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight loss and body composition, will be evaluated among these patients.

NCT ID: NCT02076997 Completed - Cancer Clinical Trials

Individualized High Dose Methotrexate to Treat Cancer in Children Who Have a Significant Risk for Side Effects to Methotrexate

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Pediatric cancer patients are being asked to take part in this study who have a cancer that is treated with high doses of the drug methotrexate (MTX). In addition, these patients have either had significant side effects to methotrexate in the past or their doctor thinks that they are at high risk for side effects from receiving methotrexate. Methotrexate is a cancer-fighting drug that is very important in the treatment of leukemia. In this study, investigators are testing a new method of giving high dose methotrexate to cancer patients which may reduce the chances that the level of methotrexate in the blood is too high. When the levels are too high this is thought to lead to an increase in side effects. Side effects are unintended and unwanted results of treatment. The initial ordered amount of methotrexate and the period over which methotrexate is given will not change from the current standard of care (meaning what is usually done by doctors, and would likely be done if the patient was not on this study). This study is testing a new method of monitoring and potentially adjusting the final amount of methotrexate that the patient will end up receiving based on levels of methotrexate in the blood in the first 24 hours in order to try to prevent side effects in patients with a previous history of side effects from methotrexate or who are at high risk for having side effects. On this study the investigators will check methotrexate levels in the blood 2 hours after the patient starts receiving the drug and the investigators will lower the dose of methotrexate if needed. Investigators will do the same thing again 6-8 hours later. Investigators will also collect an optional blood sample from the patient because the investigators want to study how genetic (DNA) differences are involved in how the body processes methotrexate.

NCT ID: NCT02073682 Completed - Cancer Clinical Trials

Cancer Venous Thromboembolism (VTE)

Start date: July 16, 2015
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

NCT ID: NCT02073474 Completed - Cancer Clinical Trials

An Observational Post-Marketing Safety Registry of Sativex®

Start date: February 2011
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to monitor safety outcomes of patients who are receiving Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United Kingdom (UK), Germany and Sweden.

NCT ID: NCT02072902 Completed - Cancer Clinical Trials

Diabetes, Glucose Control, Glucose Lowering Medications, and Cancer Risk: A 10-year Population-based Historical Cohort

DBCA
Start date: March 2012
Phase: N/A
Study type: Observational [Patient Registry]

This is a large nationwide population study, with 10 year follow-up, of the effect of diabetes, metabolic control and a large number of glucose-lowering medications, on total and site-specific cancer incidence and survival. The study is based on electronic medical records from the largest Israeli health maintenance organization in Israel, Clalit Health Services. 2,301,990 insurees age 21 years old or above at study entry, January 2002 will be included. Four study groups will be established according to the prevalence of diabetes and/or cancer on that date: neither diabetes nor cancer; prevalent diabetes but not cancer; prevalent cancer but not diabetes; both diabetes and cancer prevalence. Subjects free of diabetes at study entry will be followed for diabetes incidence, and all four groups will be followed until December 2012 for study outcomes. The cohort data file will be linked to the Israel National Cancer Registry for cancer morbidity. We will compare, after adjustment, all and site-specific cancer rates between individuals with and without diabetes; and investigate if metabolic control, as indicated by HbA1c and blood glucose levels, is related to cancer risk. Using time-dependent Cox proportionate hazard models, we will then evaluate differences in outcomes that associate with the use of one or a combination of glucose-lowering treatments, while stratifying by those who were already diagnosed with diabetes at study entry, and those diagnosed during follow-up. Data for a large number of potential confounding variables, including BMI, plasma glucose, HbA1c, hormone replacement therapy and comorbidities will help mitigate allocation bias. The accessibility and uniformity of the healthcare provided by Clalit Health Services, as well as data on cancer screening tests, will minimize the risk of surveillance bias.

NCT ID: NCT02072733 Completed - Cancer Clinical Trials

Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark

Start date: January 2015
Phase: N/A
Study type: Interventional

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.