IRB #

STUDY00016998

Title

(APR-407) PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin/Pegylated Liposomal Doxorubicin (PLD) Combination Chemotherapy With or Without APR-246

Principal Investigator

Melissa Moffitt

Study Purpose

The purpose of this study is to test whether a treatment of usual care carboplatin/pegylated liposomal doxorubicin (PLD) chemotherapy combined with investigational drug APR-246 provides any benefit to treatment with carboplatin/PLD alone in women with recurrent, platinum-sensitive high-grade serous ovarian cancer that has mutation in a gene called P53.

Medical Condition(s)

Ovarian Cancer
Platinum-sensitive
p53 mutation

Eligibility Criteria

1. Confirmed high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer with disease progression between 6-24 months after a first- or second-line platinum-based chemotherapy

2. Archived tumor sample to test for p53 mutation status; only those patients with tissue that tests positive for p53 mutation will be eligible.

3. Presence of at least one measurable lesion (tumor)

6. Other inclusion/exclusion criteria will apply

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You will receive study treatments and undergo study procedures for up to 6 months unless your disease progresses, you experience side effects that are not well-tolerated, you decide to withdraw from the study, or the investigator and/or study sponsor remove you from the trial. After your study participation ends, the investigator and/or your cancer doctor will discuss with you your treatment options. You will continue to be followed by the study every 3 months until your disease progresses.

Minors Included

No

Contact

OHSU Gynecologic Oncology Study Coordinator
Yukie Bean
503-418-4522

or Knight Cancer Institute Clinical Trials Information Line
503-494-1080

Sponsor

Aprea AB

Recruitment End

06/29/2018

Compensation Provided

No


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