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

Phase 1

Terminated

• Conditions: Metastatic Cancer With Impaired Renal Function; Metastatic Cancer With Normal Renal Function
• Interventions: Drug: ASA404

• Registration Number: NCT01240642
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2010-12
• Status Verified: 2012-11
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASA404	ASA404	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax	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	12 months
To evaluate renal clearance (CLR) of ASA404.	12 months
To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)	12 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇪 Wilrijk, Belgium