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A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

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Trial Information

A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer


This study will consist of the following parts:

1. Dose Escalation - Cohorts of at least 3 participants will be treated with increasing
doses of LY2475655 until maximum tolerated dose (MTD) criteria are met in 1 of the 6
dose levels, or the 6th cohort is completed without meeting maximum tolerated dose
criteria.

2. Dose Confirmation - Up to 10 more participants will be enrolled to the MTD dose level,
or if it was not possible to define the MTD during dose escalation, all clinical and
bioanalytical data will be reviewed to select the recommended Phase 2 dose and an up to
10 additional participants will be enrolled to this dose level.


Inclusion Criteria:



- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose
of study drug

- Females with child bearing potential must have had a negative serum pregnancy test
less than or equal to 7 days prior to the first dose of study drug

- Have an estimated life expectancy of greater than 12 weeks

- Have a histological or cytological diagnosis of cancer (with the exception of breast
or prostate cancer) that is advanced and/or metastatic, for which no proven effective
therapy exists or the participant has declined anticancer therapy OR

- Have a histological or cytological diagnosis of metastatic breast or metastatic
prostate cancer and receiving stable anti-hormone therapy for at least 2 months

- Have adequate hematologic, hepatic, and renal function

- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, or any other investigational therapy, for at least 30 days (6 weeks for
mitomycin-C or nitrosoureas) prior to study enrollment and have recovered from the
acute effects of therapy. Participants receiving anti-hormone therapy as specified
in criteria above are not excluded

Exclusion Criteria:

- Have received treatment within 30 days of the initial dose of study drug with a drug
that has not received regulatory approval for any indication

- Have serious preexisting medical conditions other than their cancer (at the
discretion of the investigator)

- Have central nervous system malignancy or metastasis (screening not required)

- Have a history of severe chronic diseases that could interfere with either strength
evaluation or body mass assessment during participation in this study including, but
not limited to, ischemic disease (affecting the heart, brain, or extremities),
uncontrolled hypertension, uncontrolled pain, severe chronic obstructive pulmonary
disease, uncompensated heart failure (New York Heart Association Class III or IV),
uncontrolled diabetes, or liver cirrhosis (Child-Pugh Class C)

- Have a history of inherited or acquired neuromuscular diseases including multiple
sclerosis, muscular dystrophies, or myasthenia gravis

- Have active systemic inflammatory conditions including rheumatoid arthritis,
dermatomyositis, severe arthrosis, or scleroderma

- Have unstable bone lesions, or any bone instability, fusion, arthroplasty, tendon
repair, synovectomy, and so on, due to any of the before-mentioned conditions or due
to accident that could interfere with completion of the physical tests in this
protocol

- Have chronic glucocorticosteroid use greater than 10 mg of prednisone per day or
equivalent

- Have known positive test results for hepatitis B surface antigen (HBSAg), or
hepatitis C antibodies (HCAb). Screening is not required

- Have untreated hypothyroidism or hyperthyroidism

- Have history of seizures, convulsions (except previous febrile convulsions), or
stroke

- Present with evidence of major depressive disorder, or history of obsessive
compulsive disorder, significant psychiatric disease such as schizophrenia, bipolar
disorder, or delirium

- Have depressive symptoms associated with their cancer that require treatment with any
of the excluded drugs listed in protocol

- Have a previous history of discontinuation of a monoclonal antibody therapy due to
allergy or severe infusion reaction

- Are scheduled to start or already receive any anti-cancer hormone treatments for
breast or prostate cancer in the adjuvant or neoadjuvant setting

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for phase 2 studies

Outcome Time Frame:

Baseline to study completion (approximately 51 months)

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11207

NCT ID:

NCT01524224

Start Date:

January 2008

Completion Date:

August 2013

Related Keywords:

  • Advanced Cancer
  • Metastases
  • Neoplasm
  • Advanced Cancer
  • Metastatic Cancer
  • Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Manhassaet, New York  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Seattle, Washington  98133