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Epithelial Ovarian CancerPhase 1/2NCT01663857

A Study LY2228820 for Recurrent Ovarian Cancer

A Phase 1/2 study testing LY2228820, Carboplatin and Gemcitabine in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Eli Lilly and Company at 30 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, women only
What is being tested?
LY2228820, Carboplatin and Gemcitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
30 sitesin 4 countries
Study dates
Jul 2012to 11 May 2018
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 4 countries.

30 sites in 4 countries

United States19 sites

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Austin, Texas, 78731

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Bedford, Texas, 76022

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Fort Worth, Texas, 76104

  • SMO Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78229

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • US Oncology

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, P.C.

    Tucson, Arizona, 85710

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists PC

    Vancouver, Washington, 98684

Other trials in United States

Germany6 sites

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Germany

Australia4 sites

  • 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

  • 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

  • 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

  • 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

Other trials in Australia

Belgium1 site

  • 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

Other trials in Belgium

About this study

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

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

Read the 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.

Being tested
LY2228820, Carboplatin, Placebo, Gemcitabine
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2228820Drug

    Administered Orally

  • CarboplatinDrug

    Administered IV

  • PlaceboDrug

    Administered Orally

  • GemcitabineDrug

    Also called Gemzar, LY188011

    Administered IV

Study groups in NCT01663857
Study groupRoleWhat they receive
Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)ExperimentalCohort 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.
Receives: Drug: LY2228820; Drug: Carboplatin; Drug: Gemcitabine
Phase 1b (Cohort 2) LY2228820 300 mgExperimentalCohort 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.
Receives: Drug: LY2228820; Drug: Carboplatin; Drug: Gemcitabine
Phase 2 (Arm A) LY2228820 200 mgExperimentalArm 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.
Receives: Drug: LY2228820; Drug: Carboplatin; Drug: Gemcitabine
Phase 2 (Arm B) PlaceboPlacebo comparatorArm 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.
Receives: Drug: Carboplatin; Drug: Placebo; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Cycle 1 (21 Days)

  2. 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.

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

Secondary outcomes (4)

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

    Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    Measured: Baseline to Disease Progression (up to 3 years)

  2. Phase 2: Overall Survival

    Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.

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

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

    PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.

    Measured: 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

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

    The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = "not at all" and 4 = "very much." Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life.

    Measured: Baseline, Study Completion (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completion25 May 2017
  4. Study completion11 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01663857
Sponsor's protocol ID
12517
Other IDs
I1D-MC-JIAE
Status last verified
Aug 2019
First submitted
8 Aug 2012
Last updated
11 Sep 2019
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31791552

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LY2228820, Carboplatin and Gemcitabine in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Eli Lilly and Company at 30 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany, Australia, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD]) (time frame: Cycle 1 (21 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01663857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.

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