Non-Small Cell Lung CancerPhase 1/2NCT00832494
Phase II Study of DMXAA (ASA404) in Combination With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing DMXAA in combination with carboplatin and paclitaxel in people with Non-Small Cell Lung Cancer, run by Antisoma Research.
Trial summary
This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- DMXAA in combination with carboplatin and paclitaxel
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Aug 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC.
Read the detailed description
The study was designed to determine the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) non-small cell lung cancer. The phase Ib part of the study evaluated dose levels of DMXAA at 600 mg/m2, 1200 mg/m2 and 1800 mg/m2. In the phase II part of the study, patients were randomized to receive carboplatin and paclitaxel alone or in combination with ASA404 1200 mg/m2. An additional single-arm study was undertaken to evaluate further patients at the 1800 mg/m2 dose level.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- DMXAA in combination with carboplatin and paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMXAA in combination with carboplatin and paclitaxelDrug
Also called DMXAA is now known as ASA404
Administered every 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of combination
Tumor response rate
Time to tumor progression
Duration of response and stable disease; median and one-year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startSep 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark McKeage, Principal investigator, Auckland Medical School, Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832494
- Sponsor's protocol ID
- AS1404-201
- Status last verified
- Jan 2009
- First submitted
- 29 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22263047
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00832494
- Acronym / sponsor ID
- AS1404-201
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to test the addition of DMXAA (now known as ASA404) to carboplatin and paclitaxel in patients with NSCLC.
Detailed description
The study was designed to determine the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) non-small cell lung cancer. The phase Ib part of the study evaluated dose levels of DMXAA at 600 mg/m2, 1200 mg/m2 and 1800 mg/m2. In the phase II part of the study, patients were randomized to receive carboplatin and paclitaxel alone or in combination with ASA404 1200 mg/m2. An additional single-arm study was undertaken to evaluate further patients at the 1800 mg/m2 dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMXAA in combination with carboplatin and paclitaxelAlso: DMXAA is now known as ASA404Administered every 21 days | Drug | – |
Primary outcome
Safety and tolerability of combination
Tumor response rate
Time to tumor progression
Duration of response and stable disease; median and one-year survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 22263047McKeage 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark McKeage principal investigator
Auckland Medical School, Auckland, New Zealand
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DMXAA in combination with carboplatin and paclitaxel in people with Non-Small Cell Lung Cancer, run by Antisoma Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of combination. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.