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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00662597 |
The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: ASA404 in combination with carboplatin and paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion
Lab values within the range, as defined below, within 2 weeks of randomization:
Exclusion
Patients with any one of the following:
Pregnant or breast feeding females
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
• Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking paclitaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis U.S. | 862 778 8300 | |
Contact: Novartis Basel | 41 61 324 1111 |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASA404A2301 |
Study First Received: | April 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662597 |
Health Authority: | United States: Food and Drug Administration |
Tumor vascular disrupting agent VDA ASA404 non-small cell lung cancer NSCLC |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
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 |