Try our beta test site
Trial record 1 of 1 for:    jnba
Previous Study | Return to List | Next Study

A Study of LY3164530 in Participants With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02221882
First received: August 19, 2014
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Neoplasms
Neoplasm Metastasis
Drug: LY3164530
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting MET and EGFR, in Patients With Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 (Cycle = 28 days) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 45
Study Start Date: August 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: LY3164530
Administered IV.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT02221882

Locations
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02221882     History of Changes
Other Study ID Numbers: 15279
I7H-MC-JNBA ( Other Identifier: Eli Lilly and Company )
Study First Received: August 19, 2014
Last Updated: October 7, 2016

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on March 24, 2017