A Study of LY3164530 in Participants With Cancer

NCT02221882 | Completed Phase 1 Results

• 2 other identifiers: 15279I7H-MC-JNBA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)

  Recommended Phase 2 Dose of LY3164530: MTD

  Cycle 1 (Cycle = 28 days)

Secondary Outcomes (5)

• Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay

  Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

• Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay

  Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

• Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay

  Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

• Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay

  Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

• Number of Participants With Tumor Response

  Baseline Through Study Completion (Up to 6 Months)

Study Arms (1)

LY3164530

EXPERIMENTAL

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

Interventions

LY3164530 DRUG

Administered IV.

LY3164530

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800+545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: August 1, 2014
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Locations

US (3)