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A Study of LY3200882 in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937272
Recruitment Status : Active, not recruiting
First Posted : October 18, 2016
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE November 21, 2016
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  • Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  • PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  • ORR: Percentage of Participants with CR or PR [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months) ]
  • Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months) ]
  • Progression-Free Survival (PFS) [ Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  • PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) ]
  • ORR: Percentage of Participants with CR or PR [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months) ]
  • Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3200882 in Participants With Solid Tumors
Official Title  ICMJE A Phase 1 Study of LY3200882 in Patients With Solid Tumors
Brief Summary The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE
  • Drug: LY3200882
    Administered orally
  • Drug: LY3300054
    Administered intravenously
  • Drug: Gemcitabine
    Administered intravenously
  • Drug: nab-Paclitaxel
    Administered intravenously
  • Drug: Cisplatin
    Administered intravenously
  • Radiation: Intensity Modulated Radiotherapy
Study Arms  ICMJE
  • Experimental: LY3200882 Schedule 1 Escalation
    Intervention: Drug: LY3200882
  • Experimental: LY3200882 Schedule 2 Escalation
    Intervention: Drug: LY3200882
  • Experimental: LY3200882 Schedule 1 Expansion
    Intervention: Drug: LY3200882
  • Experimental: LY3200882 Schedule 2 Expansion
    Intervention: Drug: LY3200882
  • Experimental: LY3200882 + LY3300054
    Interventions:
    • Drug: LY3200882
    • Drug: LY3300054
  • Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel
    Interventions:
    • Drug: LY3200882
    • Drug: Gemcitabine
    • Drug: nab-Paclitaxel
  • Experimental: LY3200882 + Cisplatin + Radiation
    Interventions:
    • Drug: LY3200882
    • Drug: Cisplatin
    • Radiation: Intensity Modulated Radiotherapy
  • Experimental: Japanese Arm LY3200882
    Intervention: Drug: LY3200882
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
223
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
146
Estimated Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date February 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The participant must have histological or cytological evidence of cancer.
  • Have adequate organ function.
  • Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
  • Are able to swallow capsules and tablets.

Exclusion Criteria:

  • Have moderate or severe cardiovascular disease.
  • Have a serious concomitant systemic disorder.
  • Have acute leukemia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Italy,   Japan,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02937272
Other Study ID Numbers  ICMJE 16185
I8X-MC-JECA ( Other Identifier: Eli Lilly and Company )
2016-001431-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP