Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

NCT00169572 | Completed Phase 2

• 1 other identifier: NKV20001
• Study Type: interventional
• Target: 492
• Locations: 19 countries
• Sites: 51

Brief Summary

This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

Conditions

Nausea and Vomiting; Chemotherapy-Induced

Keywords

Nausea; Vomiting; Emesis; Chemotherapy-induced Nausea and Vomiting; CINV

Outcome Measures

Primary Outcomes (1)

• The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

Secondary Outcomes (1)

• Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

Interventions

Aprepitant DRUG

Ondansetron DRUG

GW679769 DRUG

Dexamethasone DRUG

Also known as: Aprepitant, Ondansetron, GW679769

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
• Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
• Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.

You may not qualify if:

• Not received any investigational product within 30 days of enrolment into the study.
• Must not be pregnant.
• Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
• Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
• Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
• Must not have a history of peptic ulcer disease.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Capital Federal, Buenos Aires, C1437JCP, Argentina

Location

GSK Investigational Site

Buenos Aires, C1405CBA, Argentina

Location

GSK Investigational Site

Salzburg, A-5020, Austria

Location

GSK Investigational Site

Vienna, A-1090, Austria

Location

GSK Investigational Site

Vienna, A-1130, Austria

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4020, Belgium

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500921, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Zagreb, 10000, Croatia

Location

GSK Investigational Site

Hradec Králové, 500 05, Czechia

Location

GSK Investigational Site

Ostrava - Poruba, 708 52, Czechia

Location

GSK Investigational Site

Prague, 12808, Czechia

Location

GSK Investigational Site

Prague, 154 00, Czechia

Location

GSK Investigational Site

Prague, 180 81, Czechia

Location

GSK Investigational Site

Shatin, N.T., Hong Kong

Location

GSK Investigational Site

Budapest, 1529, Hungary

Location

GSK Investigational Site

Székesfehérvár, 8000, Hungary

Location

GSK Investigational Site

Benevento, Campania, 82100, Italy

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Rome, Lazio, 00149, Italy

Location

GSK Investigational Site

Rome, Lazio, 00184, Italy

Location

GSK Investigational Site

Casalpusterlengo (LO), Lombardy, 26841, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56124, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06156, Italy

Location

GSK Investigational Site

Durango, Durango, 34000, Mexico

Location

GSK Investigational Site

Mérida, Yucatán, 97500, Mexico

Location

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

Location

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

GSK Investigational Site

Arnhem, 6815 AD, Netherlands

Location

GSK Investigational Site

Rotterdam, 3045 PM, Netherlands

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GSK Investigational Site

Utrecht, 3527 CE, Netherlands

Location

GSK Investigational Site

Karachi, 54000, Pakistan

Location

GSK Investigational Site

Lahore, Pakistan

Location

GSK Investigational Site

Callao, Provincia Constitucional del Callao, Callao 1, Peru

Location

GSK Investigational Site

Quezon City, 1101, Philippines

Location

GSK Investigational Site

Taft Avenue, Manila, 1700, Philippines

Location

GSK Investigational Site

Bydogoszcz, 85-796, Poland

Location

GSK Investigational Site

Krakow, 31-115, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Poznan, 61-866, Poland

Location

GSK Investigational Site

Bucharest, 022328, Romania

Location

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Košice, 041 90, Slovakia

Location

GSK Investigational Site

Nitra, 949 88, Slovakia

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

GSK Investigational Site

Taipei, 114, Taiwan

Location

GSK Investigational Site

Tao Yuan County, 333, Taiwan

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant; Ondansetron; casopitant; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2005
• Last Updated: May 10, 2010

Record last verified: 2010-05

Locations

AU (3); CL (2); PE (1); TW (3); PA (2); CR (1); HU (2); HK (1); PL (4); ME (2); BE (4); NL (5); PH (2); RO (1); IT (8); SL (2); AR (2); SG (1); CZ (5)