Status:
COMPLETED
Study With Pazopanib in Combination With Cisplatin (CDDP) in Patients With Advanced Solid Tumors
Lead Sponsor:
UNICANCER
Conditions:
Solid Tumors
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin. As cisplatin has marketing approval for several cancer...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Main
- 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 cancer
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01165385
Start Date
June 1 2010
End Date
October 1 2014
Last Update
November 17 2014
Active Locations (5)
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1
Centre François BACLESSE
Caen, France, 14076
2
Centre Georges François LECLERC
Dijon, France, 21079
3
Centre Léon Berard
Lyon, France, 69373 CEDEX 08
4
Centre René Gauducheau
Nantes Saint Herblain, France, 44805