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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function

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Trial Information

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


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
- Major surgery
- 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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 monnths

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2112

NCT ID:

NCT01240642

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Metastatic Cancer With Impaired Renal Function
  • Metastatic Cancer With Normal Renal Function
  • Advanced or metastatic cancer
  • refractory
  • core phase
  • extension phase
  • dose escalation
  • standard chemotherapy
  • doctaxel
  • paclitaxel
  • carboplatin
  • safety
  • tolerability
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Renal Insufficiency

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