Know Cancer

or
forgot password

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Emesis

Thank you

Trial Information

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy


5-Hydroxitryptamine3 antagonists are one of the mainstays of antiemetic treatment and they
are administered either intravenously or orally. Nevertheless sometimes neither
administration route is feasible, such as in patients unable to admit oral intake managed in
an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous
palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive
palonosetron 3 mg either subcutaneously or intravenously in a crossover manner during two
cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of
subcutaneous and IV palonosetron will be prospectively compared.


Inclusion Criteria:



- Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic
and renal function

Exclusion Criteria:

- Pregnancy

- Serious concomitant diseases, in the invesgatorĀ“s criteria

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of area under the curve and Cmax in cancer patients treated with emetogenic chemotherapy.

Outcome Time Frame:

Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment

Safety Issue:

No

Principal Investigator

Belen Sadaba, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinica Universidad de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

PAL/SC-IV-2008

NCT ID:

NCT01046240

Start Date:

October 2009

Completion Date:

November 2010

Related Keywords:

  • Emesis
  • chemotherapy
  • emesis
  • palonosetron
  • Vomiting

Name

Location