Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Colorado, Denver

About this trial

The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.

If a participant is a good fit for the study, and they enroll in the study, they will:

* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days. * Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Eligibility criteria

Qualifiers

Provision to sign and date the consent form.

Stated willingness to comply with all study procedures and be available for the duration of the study.

Woman aged ≥18 years of age

Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2

Disqualifiers

Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor

Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy

Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia.

Trial design

Treatments tested in this trial

  • Cirtuvivint
  • Olaparib

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator