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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01278758
First received: January 16, 2011
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Drug: ASA404, DMXAA or DXAA
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) [ Designated as safety issue: Yes ]
  • To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax [ Designated as safety issue: No ]
  • To evaluate renal clearance (CLR) of ASA404. [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: March 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 + standard therpy Drug: ASA404, DMXAA or DXAA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278758

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.
Indiannapolis, Indiana, United States, 46202
United States, Maryland
Hematology /Oncology Associates
Rockville, Maryland, United States, 20850
United States, Michigan
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Investigative Site
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01278758     History of Changes
Other Study ID Numbers: CASA404A2109, EudraCT 2009-017159-88
Study First Received: January 16, 2011
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Advanced or metastatic cancer,
refractory,
core phase,
extension phase,
dose escalation,
standard chemotherapy,
doctaxel,
paclitaxel,
carboplatin,
safety,
tolerability

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Renal Insufficiency
Neoplastic Processes
Pathologic Processes
Kidney Diseases
Urologic Diseases
5,6-dimethylxanthenoneacetic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014