Phase 2
N=118
A Study LY2228820 for Recurrent Ovarian Cancer
Epithelial Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01663857 ↗Enrolled (actual)
118
Serious AEs
35.6%
Results posted
May 2019
Primary outcome: Primary: Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD]) — 200 milligrams (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2228820 (Drug); Carboplatin (Drug); Placebo (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD]) |
200 | — |
| PRIMARY Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin |
10.25; 8.44 | 0.4 |
| SECONDARY Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate) |
46.6; 46.2 | — |
| SECONDARY Phase 2: Overall Survival |
29.17; 25.10 | 0.4686 |
| SECONDARY Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820 |
3470; 3560; 3170; 4270; 9350; 3270 | — |
| SECONDARY Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score |
-0.6; -8.9 | — |
Summary
A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
- Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment
- Are able to swallow tablets
- Have given written informed consent prior to any study procedures
- Have adequate blood counts, hepatic and renal function
- Have performance status equal to or less than 2 on Eastern Cooperative Oncology Group (ECOG) scale
- Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug
Exclusion Criteria
- Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
- Are currently enrolled or discontinued less than 14 days from another clinical trial
- Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.
- Must not be pregnant or breastfeeding.
- Have malignancy or metastasis of the central nervous system
- Have borderline malignancy
Data sourced from ClinicalTrials.gov (NCT01663857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.