A Phase II Study of AZD1775 plus Chemotherapy Versus Chemotherapy Alone in Patients with TP53-Mutated Ovarian, Fallopian Tube, or Peritoneal Cancer

Full Title

A Multicentre Randomised Phase II Study of AZD1775 plus Chemotherapy versus Chemotherapy Alone in Patients with Platinum-Resistant TP53-Mutated Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Purpose

Platinum-based chemotherapy is often used to treat ovarian, fallopian tube, and primary peritoneal cancers. However, when the cancer comes back despite this therapy, it can be challenging to treat. This study is looking at the effectiveness of adding the investigational drug AZD1775 to chemotherapy. This study is for women with these cancers that have come back after platinum-based chemotherapy and whose cancers contain mutations in the TP53 gene. TP53 produces a protein called p53 which helps control cell growth; when the gene is mutated, the protein doesn’t work properly, which can fuel cancer growth.

AZD1775 inhibits an enzyme called Wee1 kinase, which is active in some cancers and can make them resistant to therapy. By inhibiting Wee1 kinase, AZD1775 is designed to make cancer cells more vulnerable to the lethal effects of anticancer treatment, such as chemotherapy. It is hoped that giving AZD1775 with chemotherapy will make recurrent ovarian, fallopian tube, and primary peritoneal cancers more sensitive to anticancer drugs.

In the first part of this study, patients will be randomly assigned to receive one of three drug combinations:

  • AZD1775 plus gemcitabine, OR
  • AZD1775 plus paclitaxel, OR
  • AZD1775 plus carboplatin

In the second part of the study, the most effective combination, as determined from the first part of the study (AZD1775 plus a chemotherapy drug), will be compared with chemotherapy alone (no AZD1775). AZD1775 is taken orally (by mouth), while the other drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ovarian, fallopian tube, or primary peritoneal cancer that has come back or continued to grow despite no more than two prior regimens of chemotherapy which included a platinum-containing drug.
  • Patients’ cancers must contain a TP53 mutation
  • Patients must have recovered from the serious side effects of prior treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Karen Cadoo at 646-497-4946.

Protocol

14-268

Phase

II

Investigator

Co-Investigators