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An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01278849
Recruitment Status : Terminated
First Posted : January 19, 2011
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. The study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. The assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. The Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.

Condition or disease Intervention/treatment Phase
Histologically-proven and Radiologically-confirmed Solid Tumors Drug: ASA404 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of ASA404 in Adult Cancer Patients With Impaired Hepatic Function and With Normal Hepatic Function
Study Start Date : January 2010
Actual Primary Completion Date : November 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: ASA404 + standard therpy Drug: ASA404


Outcome Measures
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Primary Outcome Measures :
  1. (Core Phase)To evaluate the PK of a single intravenous dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function compared to matching patients with normal hepatic function [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function as compared to controls with normal hepatic function [ Time Frame: 18 months ]
  2. (Extension Phase) assess the safety & tolerability of ASA404 either alone or in combination with a sponsor approved taxane-based regimen in adult cancer patients with impaired hepatic function as compared to controls with normal hepatic function [ Time Frame: 18 months ]
  3. To assess the safety of the combined regimen on the frequency and severity of adverse events and the number of laboratory values worsening from baseline based on the CTCAE grade assessment. [ Time Frame: 18 months ]

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

Inclusion Criteria:

  • Patients having histologically-proven solid tumors, who are refractory to standard chemotherapy;
  • Patients whom chemotherapy with an investigational agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
  • Age ≥ 18 years old
  • Creatinine clearance according to Cockcroft-Gault formula ≥ 60 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 Total bilirubin ≤ 6 X ULN

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;
  • Major surgery </ 4 weeks prior to the start of study;
  • Prior exposure to VDAs or other vascular targeting agents;
  • Right bundle branch block (RBBB), complete left bundle branch block (LBBB);
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278849


Locations
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Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Milano, Italy, 2104
New Zealand
Novarts Investigative Site
Auckland, New Zealand
Novartis Investigative Site
Wellington, New Zealand
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Investigative Site
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01278849    
Other Study ID Numbers: CASA404A2105
EudraCT 2009-016471-30 ( Registry Identifier: EudraCT )
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: November 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced or metastatic cancer,
refractory,
core phase,
extension phase,
dose escalation,
standard chemotherapy,
pharmacokinetics,
 doctaxel,
paclitaxel,
carboplatin,
safety,
tolerability,
hepatic impairment
Additional relevant MeSH terms:
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Vadimezan
Antineoplastic Agents