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Sponsored by: |
UCB |
---|---|
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00152477 |
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
Condition | Intervention | Phase |
---|---|---|
Carcinoma Non-Squamous Non-Small-Cell Lung |
Drug: Carboplatin Drug: Paclitaxel Drug: CDP791 10mg/kg Drug: CDP791 20mg/kg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer |
Enrollment: | 165 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Carboplatin and paclitaxel alone.
|
Drug: Carboplatin
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
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2: Experimental
Carboplatin and paclitaxel plus CDP791 10mg/kg
|
Drug: Carboplatin
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
Drug: CDP791 10mg/kg
CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
|
3: Experimental
Carboplatin and paclitaxel plus CDP791 20mg/kg
|
Drug: Carboplatin
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
Drug: CDP791 20mg/kg
CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
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This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.
In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.
If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.
Participants will be followed up longterm, so that survival can be measured.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hungary | |
Matrahaza, Hungary | |
Budapest, Hungary | |
Pecs, Hungary | |
Nyiregyhaza, Hungary | |
Deszk, Hungary | |
Poland | |
Krakow, Poland | |
Poznan, Poland | |
Szczecin, Poland | |
Radom, Poland | |
Otwock, Poland | |
Zabrze, Poland | |
Warszawa, Poland | |
Poznan, Poland | |
Wroclaw, Poland | |
Olsztyn, Poland | |
Lodz, Poland | |
Lublin, Poland | |
Torun, Poland | |
Russian Federation | |
Moskow, Russian Federation | |
Moskow, Russian Federation | |
Samara, Russian Federation | |
Kazan, Russian Federation | |
Saint Petersburg, Russian Federation | |
Moscow, Russian Federation |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | C79102, EudraCT 2005-001731-30 |
Study First Received: | September 6, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00152477 |
Health Authority: | Hungary: National Institute of Pharmacy |
Non-small-cell-lung cancer carboplatin paclitaxel VEGF monoclonal antibody |
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 |