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Sponsors and Collaborators: |
PDL BioPharma, Inc. Biogen Idec |
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Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00654758 |
The primary purpose of this study is to examine the safety of volociximab in combination with a standard treatment of carboplatin and paclitaxel in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: M200 (Volociximab), Carboplatin, Paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of Volociximab (M200) in Combination With Carboplatin and Paclitaxel in Subjects With Previously Untreated Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 24 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Escalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel.
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Drug: M200 (Volociximab), Carboplatin, Paclitaxel
Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
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This Phase 1b, multicenter, open-label, dose-escalation study will evaluate the safety and pharmacokinetics (PK) of volociximab in combination with carboplatin and paclitaxel (C/P) as first-line treatment in subjects with Stage IIIB or IV non-small cell lung cancer (NSCLC). Volociximab doses of 10, 20, and 30 mg/kg (or 15 mg/kg if 20 mg/kg is not tolerable) with carboplatin/paclitaxel chemotherapy will be tested for determining the maximum tolerated dose (MTD). Subjects will be dosed once very 3 weeks for up to 6 cycles.
Volociximab is a high-affinity, chimeric monoclonal antibody that specifically binds to α5β1 integrin, a cell-surface receptor for fibronectin. Volociximab blocks the binding of α5β1 to fibronectin, thereby inhibiting a pivotal interaction required for angiogenesis.
More than 170 subjects with various solid tumor types have received volociximab in Phase 1 and Phase 2 single and combination studies. At the doses tested, there has not been a dose limiting toxicity (DLT) or a maximum tolerated dose (MTD) defined.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Becky Miller 717-531-1003 rmiller13@hmc.psu.edu | |
Principal Investigator: Chandra P Belani, MD | |
France | |
Institut de cancerologie Gustave Roussy | Recruiting |
Villejuif cedex, France, 94805 | |
Contact: Maud Martin +33 1 42 11 61 73 maud.martin@igr.fr | |
Principal Investigator: Benjamin Besse, MD |
Principal Investigator: | Chandra P Belani, MD | Milton S. Hershey Medical Center |
Principal Investigator: | Benjamin Besse, MD | Institut de cancerologie Gustave Roussy |
Responsible Party: | PDL BioPharma, Inc. ( Jill Henrich, Executive Director, Regulatory Affairs ) |
Study ID Numbers: | M200-1211 |
Study First Received: | April 4, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00654758 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee |
cancer carcinoma chemotherapy monoclonal antibody therapy anti-angiogenesis |
Thoracic Neoplasms Non-small cell lung cancer Carboplatin Carcinoma Antibodies, Monoclonal Antibodies Respiratory Tract Diseases |
Lung Neoplasms Paclitaxel Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Immunoglobulins |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |