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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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01240642
First received: November 11, 2010
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ 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) [ Time Frame: 12 months ] [ 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate renal clearance (CLR) of ASA404. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240642

Locations
Belgium
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01240642     History of Changes
Other Study ID Numbers: CASA404A2112, EudraCT 2009-011142-26
Study First Received: November 11, 2010
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
Docetaxel
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013