Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: November 11, 2010
Last updated: November 26, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Metastatic Cancer With Impaired Renal Function
Metastatic Cancer With Normal Renal Function
Drug: ASA404
Phase 1

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

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 monnths ]

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

Enrollment: 27
Study Start Date: January 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 Drug: ASA404


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01240642

Novartis Investigative Site
Charleroi, Belgium
Novartis Investigative Site
Jette, Belgium
Novartis Investigative Site
Lambert, Belgium
Novartis Investigative Site
Wilrijk, Belgium
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01240642     History of Changes
Other Study ID Numbers: CASA404A2112
EudraCT 2009-011142-26 ( Registry Identifier: EudraCT )
Study First Received: November 11, 2010
Last Updated: November 26, 2012

Keywords provided by Novartis:
Advanced or metastatic cancer
core phase
extension phase
dose escalation
standard chemotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Renal Insufficiency
Neoplastic Processes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017