Know Cancer

or
forgot password

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

Thank you

Trial Information

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function


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: Parallel 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 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:

CASA404A2109

NCT ID:

NCT01278758

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • 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

Name

Location

Seattle Cancer Care AllianceSeattle, Washington  98109
Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.Indiannapolis, Indiana  46202
Hematology /Oncology AssociatesRockville, Maryland  20850
Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health SystemDetroit, Michigan  48202