Clinical trial · Interventional
A Study LY2228820 for Recurrent Ovarian Cancer
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38 MAPK Inhibitor, Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin for Women With Platinum-Sensitive Ovarian Cancer
NCT01663857CI-TRIAL-00040516completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| LY2228820 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)
- description
- Cohort 1: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 milligrams per square meter (mg/m\^2) administered intravenously (IV) over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.. Cohort 1: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.
- interventionNames
- Drug: LY2228820
- Drug: Carboplatin
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Phase 1b (Cohort 2) LY2228820 300 mg
- description
- Cohort 2: Cycles 1-6 (21 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Cohort 2: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVergote I, Heitz F, Buderath P, Powell M, Sehouli J, Lee CM, Hamilton A, Fiorica J, Moore KN, Teneriello M, Golden L, Zhang W, Pitou C, Bell R, Campbell R, Farrington DL, Bell-McGuinn K, Wenham RM. A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer. Gynecol Oncol. 2020 Jan;156(1):23-31. doi: 10.1016/j.ygyno.2019.11.006. Epub 2019 Nov 29. PMID 31791552