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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by (Responsible Party): | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01159964 |
Purpose
The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer Lung Cancer, Non-Small Cell |
Biological: Immunotherapeutic GSK2302032A, different formulations |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of GSK2302032A Antigen-Specific Cancer Immunotherapeutic in Patients With Resectable Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Subjects will receive investigational dose-level A (different from dose-levels B and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
|
Biological: Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Other Name: PRAME ASCI
|
|
Experimental: Cohort 2
Subjects will receive investigational dose-level B (different from dose-levels A and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
|
Biological: Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Other Name: PRAME ASCI
|
|
Experimental: Cohort 3
Subjects will receive investigational dose-level C (different from dose-levels A and B). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
|
Biological: Immunotherapeutic GSK2302032A, different formulations
Intramuscular administration
Other Name: PRAME ASCI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patient of childbearing potential may be enrolled in the study, if the patient:
Exclusion Criteria:
Contacts and Locations
Show 35 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01159964 History of Changes |
| Other Study ID Numbers: | 113174 |
| Study First Received: | July 8, 2010 |
| Last Updated: | May 17, 2012 |
| Health Authority: | Italy: Istituto superiore di sanità Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych France: Afssaps - French Health Products Safety Agency Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation Poland: Ewa Kopacz Italy: Segreteria Commissione per l'ammissibilità alla sperimentazione clinica di Fase I Istituto Superiore di Sanità Germany: Paul-Ehrlich-Institut United States: Food and Drug Administration |
|
Antigen-Specific Cancer Immunotherapeutic (ASCI) PRAME PRAME-positive stage IB, II or IIIA Non-Small Cell Lung Cancer patients after complete surgical resection Non-Small Cell Lung Cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |