Trial Search Results

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

This study is being carried out to see if a new treatment being tested, called olaparib, is effective in treating ovarian cancer and preventing it from coming back as quickly as it could otherwise do without any medication. The current medical practice is not to take further medications until the cancer comes back.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Myriad Genetic Laboratories, Inc.

Intervention(s):

  • Drug: Olaparib 300mg tablets

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Female patients with newly diagnosed, histologically confirmed, high risk advanced
   (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid
   ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have
   completed first line platinum based chemotherapy (intravenous or intraperitoneal).

   - Stage III patients must have had one attempt at optimal debulking surgery (upfront or
   interval debulking). Stage IV patients must have had either a biopsy and/or upfront or
   interval debulking surgery.

   - Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected
   deleterious (known or predicted to be detrimental/lead to loss of function).

   - Patients who have completed first line platinum (e.g. carboplatin or cisplatin),
   containing therapy (intravenous or intraperitoneal) prior to randomisation:

   - Patients must have, in the opinion of the investigator, clinical complete response or
   partial response and have no clinical evidence of disease progression on the post
   treatment scan or rising CA-125 level, following completion of this chemotherapy
   course. Patients with stable disease on the post-treatment scan at completion of first
   line platinum-containing therapy are not eligible for the study.

   - Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

   - BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants
   of uncertain clinical significance" or "Variant of unknown significance" or "Variant,
   favor polymorphism" or "benign polymorphism" etc).

   - Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)

   - Stable disease or progressive disease on the post-treatment scan or clinical evidence
   of progression at the end of the patient's first line chemotherapy treatment.

   - Patients where more than one debulking surgery has been performed before randomisation
   to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable
   and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and
   interval debulking surgery are eligible).

   - Patients who have previously been diagnosed and treated for earlier stage ovarian,
   fallopian tube or primary peritoneal cancer.

   - Patients who have previously received chemotherapy for any abdominal or pelvic tumour,
   including treatment for prior diagnosis at an earlier stage for their ovarian,
   fallopian tube or primary peritoneal cancer. (Patients who have received prior
   adjuvant chemotherapy for localised breast cancer may be eligible, provided that it
   was completed more than three years prior to registration, and that the patient
   remains free of recurrent or metastatic disease).

   - Patients with synchronous primary endometrial cancer unless both of the following
   criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of
   endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid
   adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with
   Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell
   adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting