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

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

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 or metastatic non-small cell lung cancer

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: ASA404 in combination with docetaxel Drug: Placebo in combination with docetaxel	Phase III

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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel 5,6-Dimethylxanthenoneacetic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Overall survival [ Time Frame: Following treatment discontinuation or documented disease progression, patients will be followed every six weeks for survival until either death or the data cut off date when the required number of OS events has been observed. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Overall response rate [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Biomarker assessments [ Time Frame: 3 months before end of study ] [ Designated as safety issue: No ]
Pharmacokinetic assessments [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	December 2008
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

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

+1 800 340 6843

Show 176 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

NCT Link

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CASA404A2302, EUDRACT number: 2008-002309-38
Study First Received:	August 19, 2008
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00738387 History of Changes
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
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
5,6-dimethylxanthenoneacetic acid
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009