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Studies
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Thoracic(12 Records found)
CTO#: 101202
Lung
Status: Active/Enrolling
Sponsor: NIH ()
Improving Clinical Communication Skills
No Documents currently available
...details...
CTO#: 101273
Kidney, Lung, Soft Tissue
Status: Active/Enrolling
Sponsor: MUSC (101273)
A Phase I Safety and Tolerability Study of LBH589 in Combination with Sorafenib in Patients with Advanced Renal Cell Carcinoma, Soft Tissue Sarcoma, and Non-small Cell Lung Carcinoma (NSCLC) of Non-squamous Histologies
Lay Description: The purpose of this study is to determine if a new investigational drug called LBH589, which has not yet been approved by the Food and Drug Administration (FDA), is safe and tolerable when given in combination with Sorafenib for the treatment of certain types of lung kidney and soft tissue cancers. Sorafenib is a medication approved by the FDA and used in treating kidney cancer. This study is investigational because the combination of these two drugs LBH589 and Sorafenib have not yet been approved by the FDA for use in these types of cancer. Sorafenib works by slowing the spread of cancer cells. LBH589 slows the growth of the enzyme histone deacetylase (a protein that speeds up chemical reactions in the body), which causes cancerous cells to die. Patients will be asked to take 2 tablets of Sorafenib by mouth twice a day along with the study drug LBH589 that will be given by tablet as well on certain days during your study cycle. The first dose of LBH589 that patients receive has been determined as a safest dose based on previous study information. Increasing doses of LBH589 will then be given depending on how you and other study participants are reacting to the drug. LBH589 will increase until it is determined that the highest dose given is causing too many side effects. At that point, it may also be possible for the dose of Sorafenib that you receive to be reduced if it is also causing too many side effects in combination with the highest dose of LBH589. You will receive the combination of study drugs for a maximum of 24 months.
Tags: Phase I, Advanced Renal Cell Carcinoma, Soft Tissue Sarcoma,Non-small Cell Lung Carcinoma (NSCLC) of Non-squamous Histologies
HIPAA Authorization
Informed Consent
Protocol
...details...
CTO#: 101349
Esophagus, Lung
Status: Active/Enrolling
Sponsor: MUSC (101349)
Molecular Markers of Malignancy Compared to Histology in Bronchial Samples Identified Using Narrow Band Imaging (NBI) Bronchoscopy or White-Light Bronchoscopy for Evaluation of Normal, Pre-Malignant and Malignant Airways Disease
No Documents currently available
...details...
CTO#: 101496
Lung
Status: Active/Enrolling
Sponsor: University of Virginia (5495)
Lung Cancer Biospecimen Resource Network - Biospecimen Collection
Lay Description: This study is for patients with lung cancer. The purpose of this study is to collect and store biologic specimens from people who have lung cancer for use in future research studies to help better diagnose and treat this disease. Patients on this study will receive the standard treatments that are appropriate for patients with lung cancer as determined by the teams of healthcare workers. Participation in this study will involve the collection of tissue samples that are “left-over” after certain clinical procedures/surgeries. Not all people will donate all kinds of specimens, and the patient does not have to donate all types of specimens in order to participate in this research. It is expected that patients will be on this study for up to 5 years.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101504
Anus, Bones and Joints, Brain and Nervous System, Breast-Female
Status: Active/Enrolling
Sponsor: MUSC (101504)
A Phase I, Open-label, Dose-Escalation, Safety and Pharmacokinetic Study of ABC294640 in Patients with Advanced Solid Tumors
Lay Description: This study is for patients with solid tumor cancer for which there is no standard therapy available for the disease, or the disease has progressed (gotten worse) after the patient received standard therapy. This study has 2 parts. The purpose of Part I of this study is to examine the safety of the study drug and determine the safest amount of the study drug that can be given to patients who have any type of solid tumor cancer. The purpose of Part II of the study is to examine the safety and tolerable amount of ABC294640 in only patients with cancer of the pancreas. Patients on this study will receive study drug ABC294640 will be given orally (by mouth) twice a day (12 hours apart) continuously for 28 days. A cycle will be defined as 28 days. Whether the patient enrolls to Part I or Part II of the study, the patient will return to clinic for weekly assessments during Cycle 1. Regardless of which part of the study the patient was enrolled in, the patient may continue to receive therapy with the study drug until the disease gets worse, the patient has side effects that require the patient to stop taking the study drug, or the patient decides they no longer wish to take the study drug.
HIPAA
Informed Consent
Investigator's Brochure
Protocol
...details...
CTO#: 101539
Esophagus
Status: Active/Enrolling
Sponsor: RTOG (1010)
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Lay Description: To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101569
Lung
Status: Active/Enrolling
Sponsor: Novartis (BKM120D2201)
An Open Label Two-Stage Study of Orally Administered BKM120 in Patients with Metastatic Non-Small Cell Lung Cancer with Activated PI3K Pathway
Lay Description: This study is for patients with non-small cell lung cancer (NSCLC) that has progressed after previous treatment. The main purpose of this study is to find out if the drug BKM120 is safe and has positive effects in people who have metastatic non-small cell lung cancer (NSCLC). Every patient in stage 1 of this trial will receive BKM120. In stage 2 of the study, patients will receive either BKM120 or docetaxel or pemetrexed. The study doctor will tell patients if he/she will be enrolled in stage 1 or stage 2. If the patient is enrolled in stage 2, the study doctor will decide whether the patient will receive docetaxel or pemetrexed. Both docetaxel and pemetrexed are standard treatments for this type of cancer. It is thought that BKM120 may stop tumor growth or possibly shrink it. This decision will be based on measuring the size of the tumor. Patients are asked to come to the MUSC clinic site approximately every 10 days. Some visits may take 3-6 hours. The screening and end of treatment visits take about 6 hours. Most cycle, day 1 visits take about 4 – 5 hours and day 10 visits about 3-4 hours
Patients will continue in the study with treatment until the disease progresses, patients experience unacceptable side effects, or the patient decided to withdraw consent.
HIPAA
Informed Consent-Biomarkers
Main Consent
Patient Materials
Protocol
...details...
CTO#: 101662
Status: Active/Enrolling
Sponsor: Genentech, Inc. (OAM4971g)
A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATION WITH TARCEVA (ERLOTINIB) IN PATIENTS WITH MET DIAGNOSTIC−POSITIVE NON−SMALL CELL LUNG CANCER (NSCLC) WHO HAVE RECEIVED STANDARD CHEMOTHERAPY FOR ADVANCED OR METASTATIC DISEASE
Lay Description: This study is for patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) and have previously failed treatment with at least one standard chemotherapy regimen. The purpose of this study is to determine whether the combination of study drug Onartuzumab plus a chemotherapy drug erlotinib is more effective than placebo (a substance containing no medication) plus erlotinib after standard chemotherapy in patients with Met diagnostic−positive (tumors with high Met protein levels) NSCLC. Patients on this study will be randomly assigned (by chance) to one of two treatment arms, Arm A and Arm B. Arm A patients will receive erlotinib and Onartuzumab. Arm B patients will receive erlotinib and placebo (an inactive stubstance). There is not a definite amount of time that patients will remain in this study. While patients are on the study, they will come in once every three weeks for a visit. The first visit will take about 4-6 hours and then all subsequent visits while take 3-5 hours. When patients are in follow-up, they will be expected to come in for a visit once every three months for the rest of their life. These visits will take 2-4 hours.
EQ-5D_Health_Questionnaire
EuroRSCG_MetLungTrial_Website
HIPAA
Informed Consent
Optional Consent
Patient Diary
Protocol
QLQ-C30
QLQ-LC13
Substudy Consent
tarceva prescribing information
...details...
CTO#: 101818
Status: In Approval Process
Sponsor: Eli Lilly (I4X-MC-JFCL(a))
A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung
Cancer (NSCLC)
Lay Description:
No Documents currently available
...details...
CTO#: 101839
Kidney, Other Male Genital, Other Urinary, Prostate
Status: Active/Enrolling
Sponsor: MUSC ()
Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients with Advanced Cancer
Lay Description: This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer. The term "phytochemicals" refers to a wide variety of compounds produced by plants. They are found in fruits, vegetables, beans, grains, and other plants. This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract. Subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes) will receive grape seed extract alone once or twice a day for 21 days. Then subjects will begin taking Vitamin D-3 at a fixed dose for 42 days. It is anticipated that this study may last approximately 65 days.
FACT-P Questionnaire
HIPAA
Informed Consent
Patient Diary_COHORT 1_D1-21
Patient Diary_COHORT 1_D22-63
Patient Diary_COHORT 2-4_D1-21
Patient Diary_COHORT 2-4_D22-63
Protocol
...details...
CTO#: 101860
Status: Active/Enrolling
Sponsor: Celgene (CC-122-ST-001)
A Phase 1A/1B, Multi-Center, Open-Label, Dose Finding Study to Assess The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of The Pleiotropic Pathway Modifier CC-122 Administered Orally To Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma Or Multiple Myeloma
Lay Description: This study is for subjects that have cancer that has spread or that cannot be cured by surgery, drugs, or any other known treatments. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. CC-122 belongs to a new class of drugs called “PPMs.” These drugs affect how the immune system works, slow the growth of tumor cells and block blood vessel growth in tumors. Approximately 100 people will take part in this study. The goal of this study is to test the highest, and/or the near-highest tolerated dose level. It may be necessary to test more than one dose level. This study will take place in the United States and in countries in Europe. This study will take about 18 to 24 months to complete. This study is only open to certain types of cancer including: (1) locally advanced (including inflammatory) breast cancer (LABC), (2) hepatocellular carcinoma (HCC), (3) certain types of brain tumor called glioblastoma multiforme (GBM), (4) multiple myeloma (MM), and (5) diffuse large B-cell lymphoma (DLBCL).
Consent
HIPAA
Patient Diary
Protocol
...details...
CTO#: 101905
Status: In Approval Process
Sponsor: (PR610-1001)
A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects with Solid Tumors
Lay Description:
No Documents currently available
...details...
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