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NCT ID: NCT01776541 Completed - Clinical trials for Pandemic H5N1 Influenza

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.

NCT ID: NCT01776528 Completed - Diabetes Mellitus Clinical Trials

Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants

Start date: January 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01775137 Completed - Clinical trials for Long-term Safety of TIP

Ext. Long-term Safety Study in CF Patients: Single Arm TIP

Start date: February 2013
Phase: Phase 4
Study type: Interventional

The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

NCT ID: NCT01774786 Completed - Gastric Cancer Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

JACOB
Start date: June 10, 2013
Phase: Phase 3
Study type: Interventional

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

NCT ID: NCT01774344 Completed - Clinical trials for Carcinoma, Hepatocellular

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

RESORCE
Start date: May 14, 2013
Phase: Phase 3
Study type: Interventional

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

NCT ID: NCT01774019 Completed - Clinical trials for Pancreatic Carcinoma

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Start date: February 20, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

NCT ID: NCT01773408 Completed - Clinical trials for Myelogenous Leukemia, Acute

A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

Start date: February 2013
Phase: Phase 1
Study type: Interventional

This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

NCT ID: NCT01773018 Completed - Tumor Clinical Trials

Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

HMPL-504
Start date: February 2012
Phase: Phase 1
Study type: Interventional

Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of c-Met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity against c-Met kinase and its downstream signaling targets and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HMPL-504 at single doses and multiple doses.

NCT ID: NCT01772836 Completed - Healthy Volunteers Clinical Trials

Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

Start date: March 2013
Phase: Phase 1
Study type: Interventional

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.