Metastatic Cancer With Impaired Renal Function Clinical Trial
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
| NCT number | NCT01240642 |
| Other study ID # | CASA404A2112 |
| Secondary ID | EudraCT 2009-011 |
| Status | Terminated |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Verified date | November 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 27 |
| Est. completion date | |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novartis Investigative Site | Charleroi | |
| Belgium | Novartis Investigative Site | Jette | |
| Belgium | Novartis Investigative Site | Lambert | |
| Belgium | Novartis Investigative Site | Wilrijk |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 monnths | ||
| Secondary | 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 | 12 months | ||
| Secondary | To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function | 12 months | ||
| Secondary | To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) | 12 months | ||
| Secondary | To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax | 12 months | ||
| Secondary | To evaluate renal clearance (CLR) of ASA404. | 12 months |