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An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Excretion (ADME) of ASA404 After a Single Intravenous Infusion of 3000 mg [14C]ASA404 in Patients With Advanced Solid Tumor Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Excretion (ADME) of ASA404 After a Single Intravenous Infusion of 3000 mg [14C]ASA404 in Patients With Advanced Solid Tumor Malignancies


Inclusion Criteria:



- Histologically proven diagnosis of advanced or metastatic solid tumors for whom
either refractory to standard therapy exists, or for whom treatment with an
investigational agent alone or in combination with docetaxel, paclitaxel,
carboplatin, or paclitaxel plus carboplatin is appropriate;

- ANC≥ 1.5 x 109/L;

- Hgb ≥ 9.0 g/L;

- PLT ≥ 100,000/mm3;

- Total bilirubin ≤ 1.5;

- Willing and able to remain in the clinic for at least 4 days

Exclusion Criteria:

- Patients with CNS and/or leptomeningeal disease metastases allowed on the study
unless asymptomatic and not requiring corticosteroid therapy. Patients having any
clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule
out CNS metastases in order to be eligible for study participation. Patients who
have had brain metastases surgically removed or irradiated with no residual disease
confirmed by imaging are allowed;

- Patients unable to undergo intravenous infusion;

- Patients with a Baseline 12-lead EGC QTc of >450 msec;

- Radiotherapy in less than two (2) weeks prior to study entry;

- A history of noncompliance to medical regimens or inability or unwillingness to
return for all scheduled visits

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

characterize the pharmacokinetic profiles of ASA404 and any potential metabolite(s) in plasma and pharmacokinetic profiles of the total radioactivity in blood and plasma after a single intravenous infusion of 3000 mg [14C] ASA404 (60 µCi)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Investigative

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2108

NCT ID:

NCT01299701

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Advanced or metastatic cancer
  • refractory
  • core phase
  • extension phase
  • dose escalation
  • standard chemotherapy
  • docetaxel
  • paclitaxel
  • carboplatin
  • safety
  • tolerability
  • Neoplasms

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