A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

Metastatic Cancer Clinical Trial

Official title:

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01278758
• Other study ID #: CASA404A2109
• Secondary ID: EudraCT 2009-017
• Status: Terminated
• Phase: Phase 1
• Start date: March 2010

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. primary completion date: November 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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Renal Insufficiency

Intervention

Drug:
• ASA404, DMXAA or DXAA

Locations

Country	Name	City	State
United States	Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System	Detroit	Michigan
United States	Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.	Indianapolis	Indiana
United States	Hematology /Oncology Associates	Rockville	Maryland
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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 months
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)
Secondary	To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax
Secondary	To evaluate renal clearance (CLR) of ASA404.

External Links

•   Results for CASA404A2109 can be found on the Novartis Clinical Trial Results Website