ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3164530 in Participants With Cancer

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: NCT02221882
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

August 19, 2014
August 21, 2014
July 11, 2017
August 2014
March 7, 2017   (Final data collection date for primary outcome measure)
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (Cycle = 28 days) ]
Recommended Phase 2 Dose of LY3164530: MTD
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (Cycle = 28 days) ]
Complete list of historical versions of study NCT02221882 on ClinicalTrials.gov Archive Site
  • Maximum Concentration (Cmax) of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
    Cmax of LY3164530
  • Area Under the Plasma Concentration-Time Curve of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
    Area Under the Plasma Concentration-Time Curve of LY3164530
  • Number of Participants with Tumor Response [ Time Frame: Baseline through study completion (estimated as up to 6 months for each participant) ]
    Number of Participants with Tumor Response
  • Maximum Concentration (Cmax) of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
  • Area Under the Plasma Concentration-Time Curve of LY3164530 [ Time Frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1) ]
  • Number of Participants with Tumor Response [ Time Frame: Baseline through study completion (estimated as up to 6 months for each patient) ]
Not Provided
Not Provided
 
A Study of LY3164530 in Participants With Cancer
A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting MET and EGFR, in Patients With Advanced or Metastatic Cancer
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasms
  • Neoplasm Metastasis
Drug: LY3164530
Administered IV.
Experimental: LY3164530
LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Intervention: Drug: LY3164530
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Same as current
March 7, 2017
March 7, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
  • Have adequate organ function.
  • Prior Treatments:

    • Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:

      • Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
      • Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
    • Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
  • If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
  • If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.

Exclusion Criteria:

  • Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
  • Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
  • Must not have a serious preexisting medical conditions or concomitant disorders.
  • Must not have leukemia.
  • Must not have QT interval of >470 millisecond.
  • Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02221882
15279
I7H-MC-JNBA ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2017

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