A Study of LY2228820 for Recurrent Ovarian Cancer
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Purpose
A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Drug: LY2228820 Drug: Carboplatin Drug: Placebo Drug: Gemcitabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Phase 1b: Recommended Phase 2 Dose of LY2228820 [ Time Frame: Cycle 1 (21 Days) ] [ Designated as safety issue: No ]
- Phase 2: Progression-Free Survival [ Time Frame: Baseline to Date of Disease Progression or Death from any cause (estimated up to 3 years) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Baseline to Date of Death from any cause (estimated up to 5 years) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 116 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1b 200 mg LY2228820
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. |
Drug: LY2228820
Administered Orally
Drug: Carboplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Names:
|
|
Experimental: Phase 1b 300 mg LY2228820
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. |
Drug: LY2228820
Administered Orally
Drug: Carboplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Names:
|
|
Experimental: Phase 2 dose LY2228820
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. |
Drug: LY2228820
Administered Orally
Drug: Carboplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Names:
|
|
Placebo Comparator: Phase 2 Placebo
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. |
Drug: Carboplatin
Administered IV
Drug: Placebo
Administered Orally
Drug: Gemcitabine
Administered IV
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY(1-877-285-4559 or | 1-317-415-4559 |
Show 34 Study Locations| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time *UTC/GMT-5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01663857 History of Changes |
| Other Study ID Numbers: | 12517, I1D-MC-JIAE |
| Study First Received: | August 8, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Gemcitabine Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013