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Cancer clinical trials

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NCT ID: NCT01253707 Completed - Cancer Clinical Trials

A Study of AMG 337 in Subjects With Advanced Solid Tumors

Start date: December 8, 2010
Phase: Phase 1
Study type: Interventional

First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.

NCT ID: NCT01248676 Completed - Cancer Clinical Trials

An Evaluation of the Usability and Usefulness of a Multi-language Online Patient Education Module

Start date: December 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if multi-language patients will find the multi-language capabilities of the online modules useful for better understanding of the general information regarding radiation therapy.

NCT ID: NCT01248611 Completed - Cancer Clinical Trials

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

NFCP1-2010
Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.

NCT ID: NCT01248429 Completed - Cancer Clinical Trials

Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases

TKI-CPK-1003
Start date: November 2010
Phase: N/A
Study type: Observational

This study describes the elevation of CPK in patient treated for solid tumors by TKI

NCT ID: NCT01247532 Completed - Cancer Clinical Trials

Pilot Study of Mindfulness-Based Stress Reduction for Patients With Persistent Cancer-Related Fatigue

Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purposes of the proposed study are (1) to collect data on the feasibility of offering Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce fatigue and psychological distress in cancer patients who are not in active treatment for their cancer and (2) to estimate effect sizes of the intervention for fatigue, depression, anxiety, and sleep disturbance. The investigators also will obtain preliminary effect sizes of the degree to which the intervention increases mindfulness, and the investigators will evaluate dosage effects. Findings will suggest whether a future randomized controlled trial with cancer-related fatigue (CRF) as the primary outcome is feasible and warranted. Participants will be randomly assigned to either the MBSR intervention arm or to a wait-list control arm. The MBSR intervention will consist of a weekly 2-hour class to be held for seven consecutive weeks in the Indiana University Simon Cancer Center Pavilion; the class on week six will be extended to a 3-hour "retreat." Participants will be invited to engage in daily home practice of meditation and other mindfulness exercises. All participants will complete a series of self-report questionnaires prior to the start of the classes, immediately following the end of classes, and 1 month after the class ends. Those in the intervention arm will begin the MBSR class the week after enrollment; the control group will be offered the same 7-week program after 1-month post-intervention follow-up assessments are completed—approximately 13 weeks after enrollment. Primary Aim 1: Obtain preliminary RCT effect sizes for changes in fatigue of an MBSR treatment group compared to a wait-list control group. Hypothesis 1: Immediately post-intervention (T2), improvements in fatigue compared to pre-intervention (T1) will be greater in the treatment group than the control group. Hypothesis 2: At 1 month post intervention (T3), improvements in fatigue compared to pre-intervention (T1) will be greater in the treatment group than improvements in the control group.

NCT ID: NCT01241461 Completed - Cancer Clinical Trials

A Study of LY2584702 in Solid Tumors

Start date: November 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.

NCT ID: NCT01240720 Completed - Cancer Clinical Trials

A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

Start date: September 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent. The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.

NCT ID: NCT01240408 Completed - Cancer Clinical Trials

E7080 Food Effect Study in Healthy Subjects

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.

NCT ID: NCT01238120 Completed - Clinical trials for Cancer-related Cognitive Difficulties

The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.

NCT ID: NCT01236053 Completed - Breast Cancer Clinical Trials

Cancer in Patients With Gabapentin (GPRD)

Start date: June 2010
Phase: N/A
Study type: Observational

High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835). The relationship between gabapentin exposure and pancreatic cancer and renal cancer is studied in NCT01138124, and supplemental analyses for these cancers are performed in the current study. The FDA recommended GSK also study the relationship between gabapentin and all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus, anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis, 7) urinary bladder, and 8) other nervous system. The primary objective of this study is to determine whether exposure to gabapentin is associated with an increased risk of developing all-cancer, and these specific cancers in the United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. The study cohort from which cases and controls are drawn is all subjects in the GPRD 1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice for age at cohort entry (within two years), sex, and year of entry into the study cohort (within one year). For cases, the index date is the date of first diagnosis of the respective cancer. The index date for controls is set as the date at which the follow-up time from cohort entry is the same as the case. The index date is chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date. Cases must have no history of any other cancer diagnosis prior to the index date. Controls are required to be free of cancer diagnosis in the database up to the control's index date. Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry to the index date. Gabapentin exposure will be assessed as ever/never, number of prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period incorporated to control for protopathic bias (gabapentin prescription for initial pain symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD cancer diagnosis). Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from conditional logistic regression models, with additional analyses evaluating for dose-response. Covariates include indications for gabapentin use and risk factors for each cancer.