Phase I of Carboplatin-Olaparib Followed by Olaparib Monotherapy in Advanced Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02418624
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin, olaparib — DRUG
    2 cycles of carboplatin and olaparib combination therapy followed by olaparib monotherapy.

Study Details

A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.

Key Dates

Start date
May 31, 2015
Status verified
Jan 2019
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    carboplatin, olaparib

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks) ]

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