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No longer recruiting (closed or complete)Last updated: 30 January 2024

This phase II trial is evaluating an intravenous drug (prexasertib) in women with platinum-resistant or refractory recurrent ovarian cancerA Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Clinical summary

Summary

Participants in this trial will be allocated into one of four cohorts based on their gene status and treatment history.

Conditions

This trial is treating people with Ovarian, Fallopian tube or Peritoneal Cancer

Eligibility

Inclusion

  • Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
  • Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.
  • Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.
  • Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.
  • Cohort 3: Are BRCA positive and have previously received a PARP.
  • Cohort 4: Have primary platinum refractory disease.
  • Have adequate organ function.
  • Must be able and willing to undergo mandatory tumor biopsy.

Exclusion

  • Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
  • Have known central nervous system malignancy or metastasis.
  • Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.
  • Have at least one of the following:

    • history of abdominal fistula or gastrointestinal perforation
    • intra-abdominal abscess within last 3 months prior to the first dose of study drug
    • a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug
  • Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).
  • Have a serious cardiac condition.
  • Have a history of prior radiotherapy to the whole pelvis.
  • Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.
  • Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back (relapsed or recurrent).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Eli Lilly and Company

Scientific Title

A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

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