Metastatic Cancer With Impaired Renal FunctionPhase 1NCT01240642
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404
A Phase 1 study testing ASA404 in people with Metastatic Cancer With Impaired Renal Function and Metastatic Cancer With Normal Renal Function, run by Novartis Pharmaceuticals at 4 sites in Belgium.
Trial summary
The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function
- What is being tested?
- ASA404
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesBelgium
- Study dates
- Jan 2010to Dec 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 histologically-proven solid tumors, who are either refractory to standard chemotherapy
- Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate
- Creatinine clearance according to Cockcroft-Gault formula : Normal > 80 mL/min, Mild 50-80 mL/min, Moderate 30-<50 mL/min
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies
- Potassium, calcium, magnesium and phosphorus values within the normal range
- Body Mass Index (BMI) must be within the range of 18 and 30
Who cannot join
- Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases
- Patients with leptomeningeal disease metastases
- Radiotherapy </- weeks prior to starting study drug
- Major surgery </ 4 weeks prior to the start of study
- Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Novartis Investigative Site
Charleroi
Novartis Investigative Site
Jette
Novartis Investigative Site
Saint-Lambert
Novartis Investigative Site
Wilrijk
About this study
Official title: A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404
The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.
- Conditions
- Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function
- Being tested
- ASA404
- Keywords
- Advanced or metastatic cancer, refractory, core phase, extension phase, dose escalation, standard chemotherapy, doctaxel, paclitaxel, carboplatin, safety, tolerability
- Medical subject headings
- Neoplasm Metastasis
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 evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Measured: 12 monnths
Secondary outcomes (5)
To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Measured: 12 months
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Measured: 12 months
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
Measured: 12 months
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
Measured: 12 months
To evaluate renal clearance (CLR) of ASA404.
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 posted15 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Cancer With Impaired Renal FunctionStudies 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
- 27 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
- NCT01240642
- Sponsor's protocol ID
- CASA404A2112
- Other IDs
- EudraCT 2009-011142-26
- Status last verified
- Nov 2012
- First submitted
- 11 Nov 2010
- 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
- A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404
- ClinicalTrials.gov ID
- NCT01240642
- Acronym / sponsor ID
- CASA404A2112
- Conditions
- Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function
- Keywords
- Advanced or metastatic cancer, refractory, core phase, extension phase, dose escalation, standard chemotherapy, doctaxel, paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 15 Nov 2010 (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 purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy
- Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate
- Creatinine clearance according to Cockcroft-Gault formula : Normal > 80 mL/min, Mild 50-80 mL/min, Moderate 30-<50 mL/min
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies
- Potassium, calcium, magnesium and phosphorus values within the normal range
Key exclusion criteria (6 listed)
- Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases
- Patients with leptomeningeal disease metastases
- Radiotherapy </- weeks prior to starting study drug
- Major surgery </ 4 weeks prior to the start of study
- Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug
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 evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 monnths
5 secondary outcomes
To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 months
To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
Time frame: 12 months
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
Time frame: 12 months
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
Time frame: 12 months
To evaluate renal clearance (CLR) of ASA404.
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 9 Dec 2020.
- Results for CASA404A2112 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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 Metastatic Cancer With Impaired Renal Function and Metastatic Cancer With Normal Renal Function, run by Novartis Pharmaceuticals at 4 sites in Belgium.
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 6 inclusion and 6 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 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 Belgium. 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?
To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function (time frame: 12 monnths). 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; AzTrials last refreshed its copy on 30 Oct 2026.