A Study of LY2228820 for Recurrent Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01663857
First received: August 8, 2012
Last updated: September 29, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: February 2018
Estimated Primary Completion Date: February 2018 (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:
  • Gemzar
  • LY188011
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:
  • Gemzar
  • LY188011
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:
  • Gemzar
  • LY188011
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:
  • Gemzar
  • LY188011

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663857

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY(1-877-285-4559 or 1-317-415-4559

  Show 31 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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: September 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urogenital Neoplasms
Adnexal Diseases
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Carboplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014