NCT01663857

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
4 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

4.9 years

First QC Date

August 8, 2012

Results QC Date

May 8, 2019

Last Update Submit

August 28, 2019

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

  • Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])

    Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).

    Cycle 1 (21 Days)

  • Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin

    PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Randomization to Date of Disease Progression or Death from any cause (up to 3 years)

Secondary Outcomes (4)

  • Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)

    Baseline to Disease Progression (up to 3 years)

  • Phase 2: Overall Survival

    Baseline to Date of Death from any cause (up to 5 years)

  • Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820

    Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD

  • Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score

    Baseline, Study Completion (up to 3 years)

Study Arms (4)

Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)

EXPERIMENTAL

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.

Drug: LY2228820Drug: CarboplatinDrug: Gemcitabine

Phase 1b (Cohort 2) LY2228820 300 mg

EXPERIMENTAL

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.

Drug: LY2228820Drug: CarboplatinDrug: Gemcitabine

Phase 2 (Arm A) LY2228820 200 mg

EXPERIMENTAL

Arm A: Cycles 1-6 (21 day cycles)- LY2228820 200 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. Arm A: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.

Drug: LY2228820Drug: CarboplatinDrug: Gemcitabine

Phase 2 (Arm B) Placebo

PLACEBO COMPARATOR

Arm B: 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 Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm B: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.

Drug: CarboplatinDrug: PlaceboDrug: Gemcitabine

Interventions

LY2228820DRUG

Administered Orally

Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)Phase 1b (Cohort 2) LY2228820 300 mgPhase 2 (Arm A) LY2228820 200 mg
CarboplatinDRUG

Administered IV

Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)Phase 1b (Cohort 2) LY2228820 300 mgPhase 2 (Arm A) LY2228820 200 mgPhase 2 (Arm B) Placebo
PlaceboDRUG

Administered Orally

Phase 2 (Arm B) Placebo
GemcitabineDRUG

Administered IV

Also known as: Gemzar, LY188011
Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)Phase 1b (Cohort 2) LY2228820 300 mgPhase 2 (Arm A) LY2228820 200 mgPhase 2 (Arm B) Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

St Josephs Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Arizona Oncology Associates, P.C.

Tucson, Arizona, 85710, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

SMO Sarah Cannon Research Inst.

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Austin, Texas, 78731, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Bedford, Texas, 76022, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Fort Worth, Texas, 76104, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

Texas Oncology - The Woodlands

The Woodlands, Texas, 77380, United States

Location

US Oncology

The Woodlands, Texas, 77380, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Northwest Cancer Specialists PC

Vancouver, Washington, 98684, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Adelaide, 5000, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Greenslopes, 4120, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nedlands, 6009, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Parkville, 3053, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leuven, 3000, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Berlin, 10117, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Essen, 45122, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Essen, 45136, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Greifswald, 17489, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mainz, 55131, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

München, 81675, Germany

Location

Related Publications (1)

  • Vergote 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: 31791552DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

ralimetinibCarboplatinGemcitabine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
Clinicaltrials.gov@lilly.com
800-575-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

July 1, 2012

Primary Completion

May 25, 2017

Study Completion

May 11, 2018

Last Updated

September 11, 2019

Results First Posted

May 29, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

DE(6)BE(1)AU(4)US(19)