Solid TumorsPhase 1NCT01299415
Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor
A Phase 1 study testing Vadimezan™ in people with Solid Tumors, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Vadimezan™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2009to Sep 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
- WHO Performance Status of 0-2.
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
- Laboratory values within the ranges, as defined below:
- ANC ≥ 1.5 X 109 /L
- Platelets ≥ 100 X 109 /L
- Hemoglobin ≥ 10 g/dL
- Serum total bilirubin is within normal range
Who cannot join
- Patients having CNS metastasis or evidence of leptomeningeal disease.
- Patients with any of the following:
- any clinical or electrocardiographic evidence of cadiac ischemia
- poorly controlled hypertension
- family history of unexplained sudden death
- long QT syndrome
Show all 16Show fewer
- history of ventricular fibrillation or torsade de pointes
- congestive heart failure (NYHA class III or IV)
- myocardial infarction within 12 months of starting study treatment
- History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
- Significant neurological or psychiatric disorder.
- Smokers (use of cigarettes within the last 3 months).
- Concomitant use of drugs that are associated with QTc interval prolongation or have a risk of causing torsade de pointes.
- Concomitant use of serotonin reuptake inhibitors (SSRIs), 5-hydroxytryptamine (5-HT) receptor agonists or selective serotonin / nor-epinephrine reuptake inhibitors (SNRIs) within 30 days prior to starting study treatment.
- Concomitant use of somatostain analogues (i.e. octreotide, lanreotide within 30 days prior to starting study treatment.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Univ. of Indiana School of Medicine/Simon Cancer Center
Indianapolis, Indiana, 46202
Masonic Cancer Center/ Clinical Trials Office
Minneapolis, Minnesota, 55455
Cancer Therapy & Research Center
San Antonio, Texas, 78229
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effects of Fluvoxamine on the Pharmacokinetics of ASA404 in Adult Patients With Solid Tumor Malignancies
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.
- Conditions
- Solid Tumors
- Being tested
- Vadimezan™
- Keywords
- ASA404,, Phase I,, Oncology,, CYP1A2,, fluvoxamine,, drug drug interaction,, Novartis,, Antisoma
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vadimezan™Drug
Also called ASA404
| Study group | Role | What they receive |
|---|---|---|
| ASA404 + Fluvoxamine | Experimental | ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase) Receives: Drug: Vadimezan™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404
Measured: approximately 2 months
Secondary outcomes (2)
evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404
Measured: 4 months
assess the safety (incidence of AEs and SAEs) of ASA404 in combination with paclitaxel, doctaxel or the paclitaxel plus carboplatin chemotherapy regimen in patients with solid tumor malignancies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 17 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
- NCT01299415
- Sponsor's protocol ID
- CASA404A2113
- Status last verified
- Aug 2011
- First submitted
- 26 Jan 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effects of Fluvoxamine on the Pharmacokinetics of ASA404 in Adult Patients With Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT01299415
- Acronym / sponsor ID
- CASA404A2113
- Conditions
- Solid Tumors
- Keywords
- ASA404,, Phase I,, Oncology,, CYP1A2,, fluvoxamine,, drug drug interaction,, Novartis,, Antisoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- First posted
- 18 Feb 2011 (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 trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASA404 + Fluvoxamine | Experimental | Drug: Vadimezan™ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
- WHO Performance Status of 0-2.
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
- Laboratory values within the ranges, as defined below:
Key exclusion criteria (16 listed)
- Patients having CNS metastasis or evidence of leptomeningeal disease.
- Patients with any of the following:
- History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
- Significant neurological or psychiatric disorder.
- Smokers (use of cigarettes within the last 3 months).
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 |
|---|---|---|
| Vadimezan™Also: ASA404 | Drug | ASA404 + Fluvoxamine |
Primary outcome
evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404
Time frame: approximately 2 months
2 secondary outcomes
evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404
Time frame: 4 months
assess the safety (incidence of AEs and SAEs) of ASA404 in combination with paclitaxel, doctaxel or the paclitaxel plus carboplatin chemotherapy regimen in patients with solid tumor malignancies
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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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.
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 Vadimezan™ in people with Solid Tumors, run by Novartis Pharmaceuticals at 4 sites in United States.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 2 Sep 2011. 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 United States. 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 was stopped early. Results are not available in the source record.
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?
evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404 (time frame: approximately 2 months). 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 2 Sep 2011.