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NCT ID: NCT01310816 Completed - Clinical trials for Conventional Chondrosarcoma

A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

Start date: February 2011
Phase: Phase 2
Study type: Interventional

IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.

NCT ID: NCT01309932 Completed - Hepatitis C Clinical Trials

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

D-LITE
Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

NCT ID: NCT01309841 Completed - Clinical trials for Opioid-Induced Constipation (OIC)

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

NCT ID: NCT01309555 Completed - Growth Disorders Clinical Trials

To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia

ECOS AUS
Start date: April 30, 2011
Phase: N/A
Study type: Observational

This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

NCT ID: NCT01309243 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

NCT ID: NCT01308580 Completed - Prostate Cancer Clinical Trials

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

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

Primary Objective: - To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: - To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m². - To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause - Prostate-Specific Antigen (PSA)-Progression - Pain progression - Tumor response in patients with measurable disease (RECIST 1.1). - PSA response - Pain response in patients with stable pain at baseline. - To compare Health-related Quality of Life (HRQL) - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

NCT ID: NCT01308567 Completed - Prostate Cancer Clinical Trials

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

FIRSTANA
Start date: May 5, 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: - To evaluate safety in the 3 treatment arms. - To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: - Progression Free Survival (PFS) (RECIST 1.1) - Tumor progression free survival (RECIST 1.1) - Tumor response in participants with measurable disease (RECIST 1.1), - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in participants with stable pain at baseline - Pain progression free survival - Time to occurrence of any skeletal related events (SRE) - To compare Health-Related Quality of Life (HRQL). - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

NCT ID: NCT01307423 Completed - Psoriatic Arthritis Clinical Trials

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

PALACE4
Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

NCT ID: NCT01307267 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

Start date: June 21, 2011
Phase: Phase 1
Study type: Interventional

A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).