- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00674102
An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)
December 6, 2020 updated by: Novartis Pharmaceuticals
An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With NSCLC
The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in combination with paclitaxel and Carboplatin are assessed.
ASA404 is administered intravenously every 21 days to Japanese patients with Non small cell lung cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aichi, Japan
- Novartis Investigative Site
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Osaka, Japan
- Novartis Investigative Site
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Shizuoka, Japan
- Novartis Investigative Site
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Tokyo, Japan
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Histologically or cytologically confirmed non-small cell carcinoma of the lung.
- Newly diagnosed Stage IIIb disease or Stage IV disease
- No prior treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Note: Prior neoadjuvant or adjuvant chemotherapy within 6 months is allowed.)
- Age ≥ 20 years old
- WHO Performance status of 0-1
Lab values within the range as defined below within 2 weeks of study registration (Note: without the use of growth factors or blood transfusions):
- Absolute neutrophil count (ANC) > 2.0 x 109/L
- Platelets ≥ 100 x109/L
- Hemoglobin ≥ 9.5 g/dL
- Serum creatinine ≤ 1.5 x ULN or 1.5 mg/dL
- Serum bilirubin ≤ 1.5 x ULN
Aspartate transaminase (AST) and alanine transaminase (ALT)
≤ 2.5 x ULN
- PT-INR ≤ 1.5 x ULN
- Potassium ≥ LLN or correctable with supplements.
- Total calcium (corrected for serum albumin) ≥ LLN or correctable with supplements.
- Magnesium ≥ LLN or correctable with supplements.
- Females of child-bearing potential must have negative pregnancy test (serum)
- Life expectancy ≥ 12 weeks
- Written informed consent obtained according to local guidelines
Exclusion criteria:
- Patients having symptomatic CNS metastases and requiring treatment
- Patients with second primary cancer, with the exception of non-melanoma skin cancer or cervical cancer in situ.
- Radiotherapy ≤ 4 weeks prior to registration (In case of palliative radiotherapy 2 weeks prior to registration
- Major surgery ≤ 4 weeks prior to registration (major surgery is defined by the use of general anesthesia). Minor surgery ≤ 2 weeks prior to registration. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.
- Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to registration
- Prior exposure to VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents
- Patients with pleural effusion to be drained (Patients who have recurrence of pleural effusion and/or it takes 2 weeks before registration after drainage are allowed)
- Patients with recent hemoptysis associated with NSCLC (>1 teaspoon in a single episode within 4 weeks)
- Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
- Peripheral sensory neuropathy with functional impairment (CTC Grade 2 neuropathy, regardless of causality)
- ≥ CTC Grade 2 cardiac arrhythmias (i.e. symptomatic, but may not require medications).
- Pregnant or breast feeding females
- Patients who take medicine that are known to prolong the QT interval
- 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.)
Patients with any one of the following
- Patients with Long QT Syndrome
- Patients with a Baseline 12-lead ECG QTc of > 450 msec in males or > 470 msec in females.
- Congestive heart failure(NY Heart Association class III or IV)
- Patients with a myocardial infarction within 12 months of study entry
- Unstable or poorly controlled angina pectoris
- History of poorly controlled hypertension with anti-hypertensive regimen
- History of a sustained ventricular tachycardia
- Any history of ventricular fibrillation or Torsades de Pointes
- Right bundle branch block and left anterior hemiblock (bifasicular block)
- Bradycardia defined as heart rate < 50 beat per minutes
- Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
- Patients known to be HBV or HCV positive
- Significant neurological or psychiatric disorder which could compromise participation in the study
- Patient unwilling or unable to comply with the protocol
- Patients who are not adequate to enter the study decided by the investigator from the medical point of view.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ASA404
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety profile and tolerability of ASA404 when administered in combination with paclitaxel and carboplatin in Japanese patients with non small cell lung cancer
Time Frame: First cycle
|
First cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize the pharmacokinetics profile of ASA404 in Japanese patients
Time Frame: every 2 cycles
|
every 2 cycles
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 5, 2008
First Submitted That Met QC Criteria
May 6, 2008
First Posted (Estimate)
May 7, 2008
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASA404A1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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