Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Sorafenib is first line treatment followed by sunitinib.

Sunitinib is first line treatment followed by sorafenib.

sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed

Sorafenib-sunitinib

sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed

Sunitinib-sorafenib

Yoshihiko Tomita, MD

The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.

Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.

From date of randomization until the date of first documented progression of the second line treatment or date of death from any cause, whichever came first, assessed up to 36 months.

Yamagata University

Clinical Professor, Head of Department of Urology

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Dyspnea

Respiratory Tract Diseases

Respiration Disorders

Signs and Symptoms, Respiratory

Respiratory System Agents

Anticonvulsants

Tiotropium Bromide

Bromides

Bronchodilator Agents

Anti-Asthmatic Agents

Parasympatholytics

Cholinergic Antagonists

Cholinergic Agents

Neurotransmitter Agents

Tiotropium

Placebo

John Goffin, MD

Sherry McFarlan, RN

The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.

Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer

Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer

Hamilton Health Sciences Corporation

Associate Prof

Infections

Digestive System Diseases

Communicable Diseases

Papillomavirus Infections

Hepatitis A

Hepatitis

Hepatitis B

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Disease Attributes

Vaccines

Allan Hildesheim, Ph.D.

Background:

- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.

Objectives:

* To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
* To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.

Eligibility:

- Women who participated in National Cancer Institute Protocol 04-C-N191.

Design:

* All participants will be offered vaccination against hepatitis B.
* Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
* Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
* Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
* All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.

Since the mid 1980 s, the Division of Cancer Epidemiology and Genetics of the National Cancer Institute in collaboration with investigators in Costa Rica has conducted studies regarding cervical cancer and HPV infection. The first effort was a case control study where Costa Rica was one of the Latin American countries included, and it was the first large epidemiological study to show the association between HPV and cervical cancer. The second study, consisting of a 10,049 women population-based cohort, the Guanacaste cohort, was carried out from 1993 until 2004, and has greatly contributed to the understanding of the natural history of HPV infection and its relationship with precancerous cervical lesions.

The profound knowledge of the natural history of HPV infection and cervical neoplasia in Guanacaste, Costa Rica together with the promising results of the different HPV vaccine trials led the National Cancer Institute, in collaboration with investigators in Costa Rica, to launch a community-based randomized phase III clinical trial to evaluate the efficacy of a virus-like particle HPV vaccine (henceforth referred to as the Costa Rica Vaccine Trial (CVT)).

The main objectives of the Costa Rica Vaccine Trial were to evaluate the efficacy of the candidate vaccine to prevent persisting HPV-16/18 infections and related histopathologically confirmed CIN2+ lesions among the according to protocol subcohort and the overall population enrolled in the study. In contrast, the objectives of this protocol are aimed at offering beneficial complementary vaccination to women enrolled in the trial with an additional objective to collect biological specimens from women receiving the HPV-16/18 vaccine to complement the information obtained during the masked phase of the trial. As an additional objective, we propose to collect information regarding exposure to known and suspected risk factors for HPV infection and cervical cancer and biological specimens during this crossover phase that will complement those collected during the masked phase of the Costa Rica Vaccine Trial.

Collection of risk factor information and biological specimens during this crossover phase will be restricted to women receiving vaccination against HPV 16/18 at crossover. These samples will permit a more complete and comprehensive evaluation of the vaccine immunogenicity. Also, those specimens will allow for ancillary analyses and studies (e.g., natural history of HPV infection acquisition/clearance) and to assist ongoing efforts to evaluate the longer-term impact of HPV-16/18 vaccination.

Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191

Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191(NCI)/IC-200403(INCIENSA)

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Breast Neoplasms

BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet

BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule

TKI258

Novartis Pharmaceuticals

Novartitis Pharmaceuticals

This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors

A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma	NCT01481870	Metastatic Rena...	Sorafenib-sunit... Sunitinib-soraf...	20 Years - 80 Years	Yamagata University
Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer	NCT01172925	NSCLC Dyspnea	Tiotropium Placebo	18 Years -	McMaster University
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma	NCT01481870	Metastatic Rena...	Sorafenib-sunit... Sunitinib-soraf...	20 Years - 80 Years	Yamagata University
Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191	NCT01086709	Cervical Neopla... HPV Infections		21 Years - 30 Years	National Institutes of Health Clinical Center (CC)
Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer	NCT01172925	NSCLC Dyspnea	Tiotropium Placebo	18 Years -	McMaster University
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors	NCT01421004	Advanced Solid ... Excluding Breas...	TKI258	18 Years -	Novartis
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors	NCT01421004	Advanced Solid ... Excluding Breas...	TKI258	18 Years -	Novartis
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma	NCT01481870	Metastatic Rena...	Sorafenib-sunit... Sunitinib-soraf...	20 Years - 80 Years	Yamagata University
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors	NCT01421004	Advanced Solid ... Excluding Breas...	TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for crossover

Every month we try and update this database with for crossover cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crossover

Every month we try and update this database with for crossover cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crossover cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.