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A Study of LY3022855 In Participants With Breast or Prostate 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: NCT02265536
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to learn more about how the investigational drug, LY3022855, affects the immune system in participants with advanced breast or prostate cancer that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6 weeks).

Condition or disease Intervention/treatment Phase
Neoplasms Neoplasm Metastasis Drug: LY3022855 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study to Identify the Immunomodulatory Activity of LY3022855 (IMC-CS4) in Patients With Advanced, Refractory Breast or Prostate Cancer
Study Start Date : May 2015
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3022855 - 1.25 mg/kg Dose A
1.25 milligram per kilogram (mg/kg) LY3022855 administered intravenously (IV), once every two weeks. Treatment is 6 week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Name: IMC-CS4

Experimental: LY3022855 - Dose B
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Name: IMC-CS4

Experimental: LY3022855 - Dose C
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Name: IMC-CS4

Experimental: LY3022855 - Dose D
LY3022855 administered IV. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Administered IV
Other Name: IMC-CS4




Primary Outcome Measures :
  1. Change from Baseline in Peripheral Blood Immune Cell Subsets [ Time Frame: Baseline to study completion, up to 6 cycles (cycle = 6 weeks) ]
  2. Change from Baseline in Serum Cytokines [ Time Frame: Baseline to study completion, up to 6 cycles (cycle = 6 weeks) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855 [ Time Frame: Baseline up to 6 cycles (cycle = 6 weeks) ]
  2. Disease Control Rate [ Time Frame: Baseline up to 6 cycles (cycle = 6 weeks) ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Confirmed diagnosis of advanced, refractory breast or prostate cancer that is evaluable by radiologic testing. Participants must have experienced tumor progression on or treatment intolerance to at least one prior therapy.
  • For participants with metastatic castrate-resistant prostate cancer only:

    • Must continue ongoing androgen deprivation therapy with castrate levels of serum testosterone <50 nanogram/deciliter (ng/dL)
    • If receiving an antiandrogen as part of first-line hormonal therapy, must have shown progression of disease off the antiandrogen prior to enrollment
    • Must be willing to continue androgen deprivation therapy while on study, if no prior orchiectomy
    • Must meet at least 1 of the following 3 criteria for progressive metastatic disease, according to Prostate Cancer Working Group 2 (PCWG2) criteria:

      • A rise in prostate-specific antigen (minimal value 2 ng/milliliter (mL); ≥3 consecutive rising values)
      • ≥2 new metastases on transaxial imaging or radionuclide bone scan
      • Soft tissue progression
    • Replacement hormone therapy initiated before study entry is permitted
    • For participants with breast cancer only:

      • May continue ongoing antiestrogen
      • Replacement hormone therapy initiated before study entry is permitted
      • May continue ongoing trastuzumab therapy
  • Have adequate organ function, including: Hepatic: Bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN. For participants with tumor involvement of the liver, AST and ALT ≤5.0 × ULN are acceptable. For participants with tumor involvement of the bone, alkaline phosphatase ≤5.0 × ULN is acceptable. Renal: Serum creatinine ≤2.0 × ULN. Absolute neutrophil count (ANC) ≥1.0 × 109/liter (L). Hemoglobin ≥9 grams per deciliter (5.58 millimoles per liter). Platelets ≥90 × 109/L.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Have discontinued all disease-modifying therapy for the primary cancer >28 days prior to initiation of study treatment. In addition, clinically significant toxicities associated with any prior therapy for the primary cancer, including investigational treatments, have resolved or stabilized to Grade ≤1 toxicity >28 days prior to initiation of study treatment with the exception of neuropathy, which must have resolved to Grade ≤2. Continuation of a stable dose (minimum of 28 days prior to study entry) of denosumab or bisphosphonate is permitted on study.
  • Willing to undergo 1 baseline and 1 posttreatment tumor biopsy procedure.
  • Male participants: Agree to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following last dose of study drug or country requirements, whichever is longer.
  • Female participants: Are women of child-bearing potential who test negative for pregnancy within 7 days prior to enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study and for 12 weeks following the last dose of the study drug and also must not be breastfeeding, OR are postmenopausal women.

Exclusion Criteria:

  • Have received treatment within 28 days prior to the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have serious preexisting medical conditions (left to the discretion of the investigator).
  • Have symptomatic central nervous system (CNS) malignancy or metastasis.
  • Have an active fungal, bacterial, and/or known viral infection, including human immunodeficiency virus (HIV) or viral (B or C) hepatitis.
  • Have any of the following cardiovascular conditions:

    • Symptomatic coronary artery disease currently or within the past 6 months,
    • Confirmed left ventricular ejection fraction ≤50% or any cardiac insufficiency > New York Heart Association (NYHA) class II currently or within the past 6 months,
    • Uncontrolled hypertension (>170/100 millimeter of mercury [mm Hg]) currently or within the past 7 days, or
    • Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
  • Have corrected QT interval of >500 millisecond (msec) on screening electrocardiogram (ECG).
  • Have received treatment with agents specifically targeting colony stimulating factor 1 (CSF-1) or CSF-1R, including imatinib, nilotinib, and sunitinib.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265536


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02265536    
Other Study ID Numbers: 15441
I5F-MC-JSCB ( Other Identifier: Eli Lilly and Company )
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes