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NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

NCT ID: NCT01022424 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Start date: November 2009
Phase: Phase 3
Study type: Interventional

ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.

NCT ID: NCT01022112 Completed - Clinical trials for Type 2 Diabetes Mellitus

An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

NCT ID: NCT01021189 Completed - Healthy Clinical Trials

Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.

NCT ID: NCT01021150 Completed - Clinical trials for Neoplasms, Malignant

Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors

Start date: March 2010
Phase: Phase 1
Study type: Interventional

Primary Objective: - To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with cisplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: - To assess the overall safety profile of the combination therapy. - To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, and cisplatin in combination. - To evaluate anti-tumor activity of the combination therapy.

NCT ID: NCT01020838 Completed - Alzheimer Disease Clinical Trials

Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

Start date: November 2009
Phase: Phase 3
Study type: Interventional

To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth

NCT ID: NCT01020786 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

Start date: November 2009
Phase: Phase 4
Study type: Interventional

To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.

NCT ID: NCT01020253 Active, not recruiting - Clinical trials for Arthroplasty, Replacement, Hip

The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)

ETOD
Start date: January 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.

NCT ID: NCT01018784 Completed - Cancer Clinical Trials

A Study of MORAb-009 in Patients With Solid Tumor

Start date: November 2009
Phase: Phase 1
Study type: Interventional

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

NCT ID: NCT01018745 Completed - Neoplasms Clinical Trials

Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.