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Chemotherapy clinical trials

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NCT ID: NCT01663441 Completed - Clinical trials for Chemotherapy-induced Thrombocytopenia

A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11

Start date: March 2015
Phase: Phase 3
Study type: Interventional

This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.

NCT ID: NCT01659775 Completed - Clinical trials for Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)

Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, open-label, paralleled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR) of Chemotherapy Induced Nausea and Vomiting (CINV). Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for 1-5 days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to HE chemotherapy). - Sancuso patch - Zofran inj. + Zofran tab. The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient will be assessed daily until 5days after first chemotherapy administration. Adverse Events (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be followed-up until 2 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.

NCT ID: NCT01651832 Completed - Colorectal Cancer Clinical Trials

Supportive Cancer Care Networkers (SCAN)

SCAN
Start date: July 2012
Phase: N/A
Study type: Interventional

Aim of the study is to increase the proportion of indicated patients with colorectal cancer undergoing adjuvant chemotherapy following surgical resection through an optimized symptom management and logistical support.

NCT ID: NCT01626547 Completed - Multiple Myeloma Clinical Trials

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

Start date: December 2010
Phase: N/A
Study type: Observational

The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

NCT ID: NCT01596400 Completed - Clinical trials for Chemotherapy Induced Nausea and Vomiting

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

NCT ID: NCT01594749 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting (CINV)

Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

NCT ID: NCT01574235 Completed - Solid Tumors Clinical Trials

Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

Start date: October 2011
Phase: N/A
Study type: Observational

The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

NCT ID: NCT01519700 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

PIONEER
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01500226 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy

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

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC administration through Day 6 in Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.

NCT ID: NCT01500213 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

HEC
Start date: February 2012
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.