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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

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

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


Inclusion Criteria:

- Documented metastatic solid malignancies for patients who are candidate to receive a
cisplatin based regimen.

- During the dose seeking procedure : ALL solid tumors

- During the Optimal Tolerated Regimen validation procedure : ONLY HER2-RH- breast

- Measurable or evaluable disease

- WHO performance status ≤ 1

- Negative dipstick proteinuria test or if positive proteinuria <1g/24h. If proteinuria
appears ≥ 2+ on routine dipstick testing, patients must undergo a 24H -urine
collection and demonstrate proteinuria < 1g/24H

- Corrected QT interval (QTc) ≤ 480 msecs using Bazett's formula

Main Exclusion Criteria:

- Prior treatment with cisplatin reaching a cumulative dose> 300 mg/m2

- HER2 positive breast cancer

- Patients at high risk of bleeding

- Clinically significant gastrointestinal abnormalities that may affect absorption of
investigational product

- calcium and magnesium levels inferior to standard levels (measured within 14 days
before the first pazopanib dose) and potassium levels inferior to standard levels
(measured within 72 hours before the first pazopanib dose)

- Patients with other concurrent severe and/or uncontrolled medical disease which could
compromise participation in the study

- Hearing impairment/tinnitus > or = grade 2

Type of Study:


Study Design:

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

Outcome Measure:

Determination of the Optimal Tolerated Regimen (OTR) based on the occurrence of Dose Limiting Toxicities

Outcome Time Frame:

cycles 1 and 2

Safety Issue:


Principal Investigator

Veronique DIERAS, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Curie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GEP 07/0908 - PACIFIK



Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumors
  • Relapsed or refractory solid tumors
  • Pazopanib
  • Cisplatin
  • Neoplasms