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NCT ID: NCT00741260 Completed - Breast Cancer Clinical Trials

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Start date: December 9, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group. Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level. In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone. The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors. The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1. The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine. Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.

NCT ID: NCT00741234 Completed - Solid Tumors Clinical Trials

A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

Start date: April 2007
Phase: Phase 1
Study type: Interventional

This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.

NCT ID: NCT00738530 Completed - Renal Cell Cancer Clinical Trials

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Start date: June 2004
Phase: Phase 3
Study type: Interventional

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in patients with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals.

NCT ID: NCT00737529 Completed - Clinical trials for Mantle Cell Lymphoma

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

EMERGE
Start date: December 22, 2008
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

NCT ID: NCT00735917 Completed - Clinical trials for Stage IV Pancreatic Cancer

Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

Start date: October 2008
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT00731276 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Irinotecan in Treating Asian Patients With Solid Tumors

Start date: April 3, 2008
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.

NCT ID: NCT00725985 Completed - Multiple Sclerosis Clinical Trials

Oral Cladribine in Early Multiple Sclerosis (MS)

ORACLE MS
Start date: December 31, 2008
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

NCT ID: NCT00722735 Completed - Clinical trials for Urinary Tract Infections

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)

FLUT
Start date: October 2008
Phase: Phase 2
Study type: Interventional

To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.

NCT ID: NCT00722137 Completed - Clinical trials for Mantle Cell Lymphoma

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

Start date: May 1, 2008
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

NCT ID: NCT00721825 Completed - Stroke Clinical Trials

Study of NeuroAid In Enhancing Recovery After Stroke

TIERS
Start date: January 2008
Phase: Phase 2
Study type: Interventional

TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.