A Study of ASA404 or Placebo in Combination With Docetaxel in Second-Line Treatment for (Stage IIIb/IV) Non-Small Cell Lung Cancer - Full Text View

Purpose

The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced non-small cell lung cancer

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: ASA404 Drug: docetaxel	Phase III

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Docetaxel 5,6-Dimethylxanthenoneacetic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Docetaxel in Second-Line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Novartis:

Primary Outcome Measures:

Overall survival [ Time Frame: 8 - 12 months ]

Secondary Outcome Measures:

Progression free survival
Overall response rate
Quality of life
Biomarker assessments
Pharmacokinetic assessments

Estimated Enrollment:	1000
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1800 mg/m2 of ASA404 intravenous (IV) on day 1 of each 21 day cycle	Drug: ASA404 1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle
2: Placebo Comparator 75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days	Drug: docetaxel 75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed non-small cell carcinoma of the lung of all histologies. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
Age ≥ 18 years old
WHO Performance Status of 0-2
Measurable or non-measurable disease per RECIST criteria (PTS-1)

Exclusion Criteria:

Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed).
Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
Major surgery ≤ 4 weeks prior to randomization (major surgery is defined by the use of general anesthesia). Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.
Treatment with first-line chemotherapy regimen ≤ 3 weeks prior to randomization (≤ 6 weeks for mitomycin and nitrosoureas)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738387

Contacts


Contact: Novartis	862-778-8300

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASA404A2302, EUDRACT number: 2008-002309-38
First Received:	August 19, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00738387
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Tumor vascular disrupting agent

VDA

ASA404

non-small cell lung cancer

NSCLC

Study placed in the following topic categories:

Docetaxel

Thoracic Neoplasms

5,6-dimethylxanthenoneacetic acid

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00738387