A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Prexasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03414047

16712

I4D-MC-JTJN (Other Identifier)

2017-004009-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.

Enrollment: 172 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 4 patient groups

Prexasertib Cohort 1

Experimental group

Description:

Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.

Treatment:

Drug: Prexasertib

Prexasertib Cohort 2

Experimental group

Description:

Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received \<3 lines of prior therapy.

Treatment:

Drug: Prexasertib

Prexasertib Cohort 3

Experimental group

Description:

Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.

Treatment:

Drug: Prexasertib

Prexasertib Cohort 4

Experimental group

Description:

Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.

Treatment:

Drug: Prexasertib