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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Histologically-proven and Radiologically-confirmed Solid Tumors
Both
Histologically-proven and Radiologically-confirmed Solid Tumors
Trial Information
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
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
- 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
Type of Study:
Interventional
Study Design:
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
(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
Outcome Time Frame:
18 months
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Investigative Site
Authority:
United States: Food and Drug Administration
Study ID:
CASA404A2105
NCT ID:
NCT01278849
Start Date:
January 2010
Completion Date:
Related Keywords:
- Histologically-proven and Radiologically-confirmed Solid Tumors
- Advanced or metastatic cancer,
- refractory,
- core phase,
- extension phase,
- dose escalation,
- standard chemotherapy,
- pharmacokinetics,
- doctaxel,
- paclitaxel,
- carboplatin,
- safety,
- tolerability,
- hepatic impairment
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