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Neoplasm Metastasis clinical trials

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NCT ID: NCT02000882 Completed - Breast Cancer Clinical Trials

STAR Cape+BKM120 MBC With Brain Met

Start date: May 29, 2014
Phase: Phase 2
Study type: Interventional

This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).

NCT ID: NCT02000739 Withdrawn - Metastatic Cancer Clinical Trials

Genetically-informed Therapies for Patients With Metastatic Cancer

GENIUS
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region. The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation. Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above. The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing. If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer. If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).

NCT ID: NCT01998607 Completed - Solid Tumours Clinical Trials

Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw

Start date: February 4, 2013
Phase: N/A
Study type: Observational

Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the most important mechanism for minimizing the risk for ONJ. The study objective is to measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining to ONJ in the SPC after commercial availability.

NCT ID: NCT01996306 Completed - Clinical trials for Colorectal Neoplasms

A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

AXEPT
Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

NCT ID: NCT01996241 Completed - Child Marriage Clinical Trials

Evaluation of an Intervention for Adolescent Girls in Karnataka

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

This cluster Randomised Control Trial is evaluating an intervention to support adolescent girls from marginalised communities in northern Karnataka State, South India to complete secondary school, thereby reducing their vulnerability to HIV infection from early marriage and entry into sex work at young ages. The intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV. School-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. Demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education. Primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will include school development and management committees (SDMCs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented with village communities and high schools in 40 village clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in collaboration with the Department of State Educational Research and Training (DSERT), Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE), Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.

NCT ID: NCT01992016 Completed - Bone Metastases Clinical Trials

A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine

Start date: April 7, 2014
Phase: N/A
Study type: Interventional

This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of glucose available for uptake by the scan.

NCT ID: NCT01991938 Terminated - Lymphoma Clinical Trials

Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma

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

This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples.

NCT ID: NCT01991015 Completed - Metastatic Cancer Clinical Trials

Goals of Care Discussions for Hospitalized Patients With Advanced Cancer

Start date: November 2013
Phase: N/A
Study type: Observational

The goal of this study is to better understand gender differences in end-of-life communication between physicians and patients with advanced cancer in the hospital.

NCT ID: NCT01985971 Completed - Clinical trials for Brain Metastases From Breast Cancer

F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer

Start date: March 2011
Phase: N/A
Study type: Interventional

To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.

NCT ID: NCT01978236 Terminated - Clinical trials for Melanoma and Brain Metastases

Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites

Start date: April 8, 2014
Phase: Phase 2
Study type: Interventional

This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. All subjects in this study are required to have accessible extracranial metastases and are agreeable to undergo repetitive biopsies. The first cohort of 15 subjects will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior to surgery (Cohort A); the second cohort of 15 subjects will receive the combination of dabrafenib 150 mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery (Cohort B). The primary purpose of this study is to determine levels and distribution of dabrafenib, its metabolites, and trametinib (Cohort B only) in parenchymal brain metastases, extracranial metastases, and peripheral blood (plasma) within two cohorts of subjects with BRAF V600E/K mutation-positive melanoma that has metastasized to the brain. All subjects will be followed for survival and new anti-cancer therapy for a total of two years or until death or the subject wishes to withdraw from further follow-up.