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NCT ID: NCT01673360 Terminated - Clinical trials for Pelvic Organ Prolapse

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

CAPTURE
Start date: September 2012
Phase: N/A
Study type: Observational

To monitor post-market performance through evaluation of short and long-term performance via: - Efficacy - Safety - Patient reported outcomes

NCT ID: NCT01672879 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NASH
Start date: October 29, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01672866 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Start date: December 5, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01659658 Terminated - Clinical trials for Relapsed or Refractory Systemic Light Chain Amyloidosis

Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Start date: December 26, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

NCT ID: NCT01659021 Terminated - Clinical trials for Chronic Lymphocytic Leukemia

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Start date: December 4, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

NCT ID: NCT01650805 Terminated - Clinical trials for Chronic Myeloid Leukemia

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

NCT ID: NCT01647789 Terminated - Prostatic Neoplasms Clinical Trials

A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer

Start date: December 4, 2012
Phase: Phase 1
Study type: Interventional

This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant. The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.

NCT ID: NCT01646125 Terminated - Clinical trials for Advanced Non Small Cell Lung Cancer (NSCLC)

An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

Start date: November 23, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

NCT ID: NCT01641939 Terminated - Gastric Cancer Clinical Trials

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

Start date: September 3, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

NCT ID: NCT01636843 Terminated - Clinical trials for Rheumatoid Arthritis

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Start date: October 30, 2012
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.