Non-small Cell Lung CancerPhase 1NCT00674102
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)
A Phase 1 study testing ASA404 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 4 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- ASA404
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesJapan
- Study dates
- Apr 2008to Mar 2009
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Novartis Investigative Site
Aichi
Novartis Investigative Site
Osaka
Novartis Investigative Site
Shizuoka
Novartis Investigative Site
Tokyo
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ASA404
- Keywords
- Vascular disrupting agent, Non-small cell lung cancer
- 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.
ASA404Drug
| Study group | Role | What they receive |
|---|---|---|
| ASA404 | Experimental | Not described Receives: Drug: ASA404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First cycle
Secondary outcomes (1)
To characterize the pharmacokinetics profile of ASA404 in Japanese patients
Measured: every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674102
- Sponsor's protocol ID
- CASA404A1101
- Status last verified
- Apr 2016
- First submitted
- 5 May 2008
- Last updated
- 9 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With NSCLC
- ClinicalTrials.gov ID
- NCT00674102
- Acronym / sponsor ID
- CASA404A1101
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Vascular disrupting agent, Non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- First posted
- 7 May 2008 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASA404 | Experimental | Drug: ASA404 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (31 listed)
- 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
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 |
|---|---|---|
| ASA404 | Drug | ASA404 |
Primary outcome
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
1 secondary outcome
To characterize the pharmacokinetics profile of ASA404 in Japanese patients
Time frame: every 2 cycles
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 9 Dec 2020.
- Results for CASA404A1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASA404 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 4 sites in Japan.
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 20 inclusion and 31 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.