A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.
A 3+3 dose escalation trial of 2 cycles (21 days) carboplatin and olaparib combination therapy, followed by olaparib monotherapy until progression or unacceptable toxicity in patients with advanced cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
2 cycles of carboplatin and olaparib combination therapy followed by olaparib monotherapy.
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Maximum Tolerated Dose
The dose level at which more than 1/6 patients develop a dose limiting toxicity
Time frame: per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks)
Pharmacokinetics (area under time-concentration curve (AUC))
Pharmacokinetics (PK) measurements of olaparib alone and olaparib in combination with carboplatin
Time frame: 1 year
Pharmacodynamics (PAR (Poly(ADP) ribose) activation measured with the PAR assay)
PAR (Poly(ADP) ribose) activation measured with the PAR assay
Time frame: 1 year
Objective Response Rate
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 1 year
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