Phase II Study of DMXAA (ASA404) in Combination With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
An Open Label, Randomized, Phase I/II Study of DMXAA in Combination With Carboplatin and Paclitaxel in Patients With Locally Advanced and Metastatic Non-Small Cell Lung Cancer
1 other identifier
interventional
105
0 countries
N/A
Brief Summary
This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started Sep 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedJanuary 30, 2009
January 1, 2009
2.9 years
January 29, 2009
January 29, 2009
Conditions
Outcome Measures
Primary Outcomes (4)
Safety and tolerability of combination
Tumor response rate
Time to tumor progression
Duration of response and stable disease; median and one-year survival
Interventions
Administered every 21 days
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-small cell lung carcinoma designated as adenocarcinoma (including bronchoalveolar), squamous cell carcinoma or undifferentiated, mixed (adenocarcinoma and squamous) or large cell carcinoma.
- Locally advanced Stage IIIb disease, not curable with surgery or radiotherapy, or Stage IV disease.
- Aged ≥ 18 years of age.
- Karnofsky performance status of ≥ 70%.
- Life expectancy of ≥ 3 months.
- Hematological and biochemical indices at screening comprising:
- An absolute neutrophil count of ≥ 2.0 x 109/L.
- A platelet count of ≥ 100 x 109/L.
- A hemoglobin level of ≥ 10 g/dL.
- Adequate hepatic and renal function as defined by serum bilirubin ≤ 25 µmol/L; alkaline phosphatase, alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal if no demonstrable liver metastasis or ≤ 5 times the upper limit of normal in the presence of liver metastasis; serum creatinine ≤ 120 µmol/L.
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
- Providing written informed consent and be able to comply with study assessments and follow-up.
You may not qualify if:
- Patients who had undergone major surgery, chemotherapy or radiation therapy (except palliative) within the previous 4 weeks.
- A known history of hypersensitivity to carboplatin, paclitaxel or any of their excipients.
- Previous exposure to DMXAA or other vascular targeting agents.
- Small cell lung cancer or mixed histology.
- Having received blood transfusions or growth factors to aid haematological recovery within 2 weeks of the scheduled baseline visit.
- Active serious infection within 2 weeks of screening.
- Clinically significant cardiac arrhythmias and known QTc prolongation.
- Evidence of severe or uncontrolled systemic disease that might interfere with study participation.
- A history of alcoholism, drug addiction or any psychiatric condition that would impair the patient's ability to comply with study procedures.
- Pregnant or lactating women and women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test.
- Patients should not have received within the two weeks prior to starting the study or be expected to need during the study period medications known to affect the QT interval or systemic serotonin levels.
- Concurrent or previous malignancy of a different tumor type within 5 years of starting the study, except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
- Clinical or radiological evidence of central nervous system metastases.
- Evidence of any other clinically significant disorder or laboratory finding that might compromise patient safety.
- Participation in any investigational drug study in which the study drug did not subsequently obtain a product license.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
McKeage MJ, Jameson MB; AS1404-201 Study Group Investigators. Comparative outcomes of squamous and non-squamous non-small cell lung cancer (NSCLC) patients in phase II studies of ASA404 (DMXAA) - retrospective analysis of pooled data. J Thorac Dis. 2010 Dec;2(4):199-204. doi: 10.3978/j.issn.2072-1439.2010.02.04.1.
PMID: 22263047DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark McKeage
Auckland Medical School, Auckland, New Zealand
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
September 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
January 30, 2009
Record last verified: 2009-01