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NCT ID: NCT01231568 Completed - Cancer Clinical Trials

An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor

Start date: October 21, 2010
Phase: Phase 1
Study type: Interventional

The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of 150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability of GSK2118436.

NCT ID: NCT01231347 Terminated - Cancer Clinical Trials

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

GAMMA
Start date: April 2011
Phase: Phase 3
Study type: Interventional

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

NCT ID: NCT01227889 Completed - Cancer Clinical Trials

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

Start date: December 23, 2010
Phase: Phase 3
Study type: Interventional

BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

NCT ID: NCT01227109 Not yet recruiting - Cancer Clinical Trials

Procalcitonin as a Marker of Infection in Cancer Patients

Start date: February 2011
Phase: N/A
Study type: Observational

Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and treatment is of paramount importance as infections may be life-threatening in immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as a marker of infection. However, the CRP is also often elevated in cancer patients and as a marker CRP may be unreliable in cancer patients. Other markers for infection includes procalcitonin which has been showed to be of some value for the diagnose of bacterial infections. This study examines procalcitonin as a potential marker of bacterial infection in cancer patients.

NCT ID: NCT01225978 Active, not recruiting - Cancer Clinical Trials

Refining Information Technology Support for Genetics in Medicine

RISGIM
Start date: September 2009
Phase: N/A
Study type: Observational

The clinical use of genetic testing is expanding and, as a result, the number of variants identified in patients is growing. Knowledge of the clinical impact of these variants improves over time. However, the combination of more testing and the rapid evolution of genetic knowledge make it impossible for clinicians to fully account for the latest implications of their patients' genetic profiles as patient care decisions are made. This proposed study plans to enhance and evaluate IT infrastructure developed to provide timely genetic variant updates and patient search functionality to clinicians to assist in optimizing patient care.

NCT ID: NCT01224730 Completed - Cancer Clinical Trials

A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies

Start date: January 24, 2012
Phase: Phase 1
Study type: Interventional

This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated. Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.

NCT ID: NCT01223924 Completed - Cancer Clinical Trials

Single-dose Escalation Trial of M2ES in Healthy Volunteer

Start date: May 2009
Phase: Phase 1
Study type: Interventional

This is a randomized double-blinded placebo-controlled,single-dose escalation trial in healthy volunteer.

NCT ID: NCT01218854 Completed - Cancer Clinical Trials

A Comparison of Methods for Assisting Needle Angle Selection During Image-guided Tissue Biopsy

Start date: March 20, 2012
Phase: Phase 1
Study type: Interventional

Background: - Currently, standard procedures for biopsies that are guided by computed tomography (CT) imaging involve CT scans and a computer program to plan and illustrate where the physician will place the needle to obtain the required cells or tissue. Inserting the biopsy needle at the planned angle is not an easy task, because the appropriate angle of insertion must be estimated based on prior experience. Researchers are studying experimental techniques that might provide better guidance about the right angle to insert the biopsy needle and thereby improve the collection of the appropriate biopsy cells or tissue. Objectives: - To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue biopsy. Eligibility: - Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy. Design: - Participants will have a tissue biopsy guided by CT scans and either a laser system or a plastic block to illustrate the appropriate angle of insertion. The skin will be numbed with anesthetic to minimize discomfort during the procedure. - Before inserting the biopsy needle, the study physician will hold the needle in place so that a Food and Drug Administration-approved medical GPS (electromagnetic tracking) system can measure the needle angle as it enters the tissue. - After the needle angle data has been collected, researchers will proceed with the actual biopsy procedure as it would normally occur, using standard methods. - No additional treatment will be provided as part of this protocol.

NCT ID: NCT01215500 Completed - Cancer Clinical Trials

Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

Start date: January 2005
Phase: Phase 1
Study type: Interventional

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy. The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.

NCT ID: NCT01215318 Completed - Cancer Clinical Trials

FDG Uptake in Vaginal Tampons is Due to Urine

Start date: February 2, 2010
Phase: N/A
Study type: Interventional

The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation. The aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.