An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors
The main objective of the study is to determine the dose limiting toxicities (DLT) and the
optimal tolerated regimen (OTR) which are both safety criteria evaluated upon the NCI CTC-AE
system version 4.0.
Efficacy is not the primary objective; however the anti-tumor activity of the
pazopanib/cisplatin combination will be carried out by the determination of the objective
response rate according to RECIST criteria version 1.1.
The objective response is defined as either a complete response (CR) or partial response
(PR), assessed either by CT Scan and/or MRI and/or bone Scan, performed at baseline and
every 6 weeks.
This is an open-label, non-randomized, dose escalation and pharmacokinetic, phase I study
pazopanib with cisplatin in patients with relapsed or refractory solid tumors (except tumors
at risk of bleeding) for whom the selected combined chemotherapy is indicated or is a
reasonable option (as per tumor characteristics and previous treatments).
All eligible patients entering the study will receive daily oral pazopanib, supplied as 200
mg aqueous film-coated tablets and intravenous cisplatin every three weeks. Doses of both
compounds will be adjusted according to the reached dose level.
The treatment will continue until the development of unacceptable toxicity or evidence of
disease progression or until patient's / investigator's decision of withdrawal.
All patients who received at least on dose of the study drug will be followed for survival
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the Optimal Tolerated Regimen (OTR) based on the occurrence of Dose Limiting Toxicities
cycles 1 and 2
Veronique DIERAS, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GEP 07/0908 - PACIFIK