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Sponsored by: |
Biothera |
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Information provided by: | Biothera |
ClinicalTrials.gov Identifier: | NCT00874107 |
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with bevacizumab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.
Condition | Intervention | Phase |
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Non-small Cell Lung Cancer |
Biological: Imprime PGG® Injection Biological: Bevacizumab Drug: Paclitaxel Drug: Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Imprime PGG + bevacizumab + paclitaxel/carboplatin
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Biological: Imprime PGG® Injection
4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
Biological: Bevacizumab
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
Drug: Paclitaxel
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Drug: Carboplatin
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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2
bevacizumab + paclitaxel/carboplatin
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Biological: Bevacizumab
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
Drug: Paclitaxel
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
Drug: Carboplatin
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has adequate hematologic function as evidenced by:
Has adequate renal function as evidenced by:
Has adequate hepatic function as evidenced by:
Has adequate coagulation function as evidenced by:
Exclusion Criteria:
Presents with any of the following medical diagnoses/conditions at the time of screening:
Has a history of any of the following medical diagnoses/conditions:
Presents with any of the following medical diagnoses/conditions at the time of screening:
a. Predominant squamous cell histology
Has a history of any of the following medical diagnoses/conditions:
Contact: Christine Mohlberg | cMohlberg@encorium.com |
Germany | |
University of Munich | Recruiting |
Munich, Germany | |
Contact: Christine Mohlberg cMohlberg@encorium.com | |
Principal Investigator: Folker Schneller, MD | |
Pius-Hospital Oldenburg | Recruiting |
Oldenburg, Germany | |
Contact: Christine Mohberg cMohlberg@encorium.com | |
Principal Investigator: Martin Griesinger, MD | |
University of Mainz | Recruiting |
Mainz, Germany | |
Contact: Christine Mohlberg cMohlberg@encorium.com | |
Principal Investigator: Martin Sebastian, MD | |
Hospital Marth-Maria Halle Dolau | Recruiting |
Halle/Saale, Germany | |
Contact: Christine Mohlberg | |
Contact cMohlberg@encorium.com | |
Principal Investigator: Wolfgang Schutte, MD | |
Clinical Kassel GmbH | Not yet recruiting |
Kassel, Germany | |
Contact: Christine Mohlberg cMohlberg@encorium.com | |
Principal Investigator: Martin Wolf, MD |
Responsible Party: | Biothera ( Michele Gargano, MSc, VP Clinical Development ) |
Study ID Numbers: | BT-CL-PGG-LCA0821 |
Study First Received: | April 1, 2009 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00874107 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
NSCLC Phase 2 Randomized Efficacy |
Safety Imprime PGG Bevacizumab |
Thoracic Neoplasms Bevacizumab Carboplatin Antimitotic Agents Angiogenesis Inhibitors Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances |
Mitosis Modulators Carboplatin Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |