Status:
TERMINATED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Cancer With Impaired Renal Function
Metastatic Cancer With Normal Renal Function
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01240642
Start Date
January 1 2010
Last Update
December 9 2020
Active Locations (4)
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1
Novartis Investigative Site
Charleroi, Belgium
2
Novartis Investigative Site
Jette, Belgium
3
Novartis Investigative Site
Saint-Lambert, Belgium
4
Novartis Investigative Site
Wilrijk, Belgium