Clinical trial NCT01240642: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
carboplatin
safety
tolerability
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (PK) of free and total ASA404.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 monnths
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function
timeFrame: 12 months
measure: To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)
timeFrame: 12 months
measure: To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
timeFrame: 12 months
measure: To evaluate renal clearance (CLR) of ASA404.
timeFrame: 12 months
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Lambert
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: