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NCT ID: NCT01357863 Terminated - Cancer Clinical Trials

Role of Early Versus Late Switch to Lapatinib-Capecitabine

(TYCO1)
Start date: July 15, 2010
Phase:
Study type: Observational

The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

NCT ID: NCT01353664 Completed - Cancer Clinical Trials

A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

Start date: May 1, 2011
Phase: Phase 2
Study type: Interventional

This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

NCT ID: NCT01352884 Completed - Cancer Clinical Trials

Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer

Start date: March 2011
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult patients with cancer that is not responding to standard therapy. This study will be conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.

NCT ID: NCT01348997 Withdrawn - Cancer Clinical Trials

E-health Intervention for Cancer Survivors 2.0

Start date: May 2011
Phase: Phase 1
Study type: Interventional

This study will develop and examine the effectiveness of an intervention that utilizes technology to improve cancer survivors' access to mental health care and increase their ability to manage the stressors involved in cancer survivorship. The intervention, referred to as Project Onward, uses an interactive website and an online social network. The purpose of this study is to pilot a novel intervention that can reduce costs, examine methods to improve adherence to internet based treatment and overcome numerous barriers to treatment for mental health concerns.

NCT ID: NCT01345019 Completed - Cancer Clinical Trials

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

NCT ID: NCT01340846 Completed - Cancer Clinical Trials

A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Start date: September 3, 2012
Phase: Phase 1
Study type: Interventional

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.

NCT ID: NCT01340833 Completed - Cancer Clinical Trials

Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Start date: June 8, 2011
Phase: Phase 1
Study type: Interventional

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is currently being developed for the treatment of BRAF mutation-positive tumors. This is an open-label, non-randomized study designed to determine the absolute bioavailability of an oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose of [14C]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will be obtained up to 72 hours post-dose. Safety assessments will be performed throughout the study. After completing all assessments, eligible subjects may transition to BRF114144, an open-label, rollover study of GSK2118436 to continue treatment.

NCT ID: NCT01340040 Completed - Cancer Clinical Trials

Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.

NCT ID: NCT01337258 Completed - Cancer Clinical Trials

Economic Analyses of the REDUCE Trial

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

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment. The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.

NCT ID: NCT01336634 Completed - Cancer Clinical Trials

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

Start date: August 5, 2011
Phase: Phase 2
Study type: Interventional

This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.