Overview

This trial is active, not recruiting.

Conditions epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Treatments ly2228820, carboplatin, placebo, gemcitabine
Phase phase 1/phase 2
Sponsor Eli Lilly and Company
Start date July 2012
End date February 2017
Trial size 116 participants
Trial identifier NCT01663857, 12517, I1D-MC-JIAE

Summary

A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Induction: Cycles 1-6 (21 day cycles)- 200 milligrams (mg) LY2228820 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 (mg-min/ml) administered IV over 30 minutes on day 3. Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.
ly2228820
Administered Orally
carboplatin
Administered IV
gemcitabine Gemzar
Administered IV
(Experimental)
Induction: Cycles 1-6 (21 day cycles)- 300 mg LY2228820 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 AUC 4 administered IV over 30 minutes on day 3. Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.
ly2228820
Administered Orally
carboplatin
Administered IV
gemcitabine Gemzar
Administered IV
(Experimental)
Induction: Cycles 1-6 (21 day cycles)- Recommended Phase 2 dose of LY2228820 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 AUC 4 administered IV over 30 minutes on day 3. Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.
ly2228820
Administered Orally
carboplatin
Administered IV
gemcitabine Gemzar
Administered IV
(Placebo Comparator)
Induction: Cycles 1-6 (21 day cycles)- Placebo 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 AUC 4 administered IV over 30 minutes on day 3. Maintenance: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.
carboplatin
Administered IV
placebo
Administered Orally
gemcitabine Gemzar
Administered IV

Primary Outcomes

Measure
Phase 1b: Recommended Phase 2 Dose of LY2228820
time frame: Cycle 1 (21 Days)
Phase 2: Progression-Free Survival
time frame: Baseline to Date of Disease Progression or Death from any cause (estimated up to 3 years)

Secondary Outcomes

Measure
Phase 2: Percentage of Participants who Achieve Complete Response or Partial Response (Overall Response Rate)
time frame: Baseline to Disease Progression ( estimated up to 3 years)
Overall Survival
time frame: Baseline to Date of Death from any cause (estimated up to 5 years)
Pharmacokinetics (PK): Area Under the Concentration Curve of LY2228820
time frame: Phase 1b Cycles 1-3 Days 1, 10 and 11 Predose up to 12 hours Postdose, Cycle 7 Day 3 Predose up to 8 hours Postdose; Phase 2 Cycles 1-2 Days 1, 3, 10 and 11 Predose up to 12 hours Postdose, Cycle 7 Day 3 Predose up to 8 hours Postdose
Phase 2: Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) score
time frame: Baseline, Study Completion (estimated up to 3 years)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Description Phase 1b is unblinded and will have a small number of participants that will take LY2228820 plus gemcitabine and carboplatin to test the safety of the combination and determine a recommended dose for the Phase 2 portion. Phase 2 will be blinded and all study participants will receive carboplatin and gemcitabine. Participants of one group will receive LY2228820, and the other group will receive placebo. If the participant achieves at least stable disease, there is a maintenance phase following the first 6 cycles. The participant will take either LY2228820 or placebo. The participant will continue therapy until disease progression or other discontinuation criteria are fulfilled.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.
Location data was received from the National Cancer Institute and was last updated in August 2016.