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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03414047

NCT03414047
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a woman diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer called "high-grade serous."
  • (Cohorts 1–3) Your cancer has stopped responding to platinum-based chemotherapy, and you have had genetic testing done on your BRCA1 and BRCA2 genes before starting the study treatment.
  • (Cohort 1) Your BRCA test came back negative, and you have already received 3 or more different rounds of cancer treatment.
  • (Cohort 2) Your BRCA test came back negative, and you have received fewer than 3 prior rounds of cancer treatment.
  • (Cohort 3) Your BRCA test came back positive, and you have previously been treated with a type of drug called a PARP inhibitor.
  • (Cohort 4) Your cancer did not respond to platinum-based chemotherapy from the very beginning.
  • Your liver, kidneys, and other organs are working well enough to safely participate.
  • You are willing and able to have a small sample of your tumor removed (biopsy) as required by the study.

Who may not be able to join:

  • (Cohorts 1–3) You have already received all three of the following chemotherapy drugs during your platinum-resistant treatment: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
  • Your cancer has spread to your brain or spinal cord.
  • You have previously taken part in a study involving a specific type of drug called a "checkpoint kinase 1 inhibitor," or you are known to be allergic to the study drug or its ingredients.
  • You have a history of an abnormal opening or tear in your abdomen or digestive tract (fistula or perforation), an infection inside your abdomen in the last 3 months, or a confirmed bowel blockage in the last 3 months.
  • You have an active HIV infection that is causing symptoms, or an active hepatitis A, B, or C infection that is causing symptoms.
  • You have a serious heart condition.
  • You have previously had radiation therapy covering your entire pelvic area.
  • You take corticosteroid (steroid) tablets or injections every day on an ongoing basis — steroid inhalers or creams applied to the skin are allowed.
  • You have known factors that could raise your risk of infection during the study, such as a drainage tube placed in your abdomen or open wounds (confirm with trial site for full details).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
10 April 2018
Est. completion
3 June 2019

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇮🇱 Israel 🇮🇹 Italy 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov