A Dose-Escalation Study in Participants With Advanced Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01524224
First received: January 30, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV) LY2495655 in participants with advanced cancer.


Condition Intervention Phase
Advanced Cancer
Drug: LY2495655
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose for phase 2 studies [ Time Frame: Baseline to study completion (approximately 51 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) of LY2495655 [ Time Frame: Baseline, Days 1, 2, 8 of Cycle 1, Day 1 of Cycle 2 and Cycle 3, Days 1, 2, 8 of Cycle 4 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) of LY2495655 [ Time Frame: Baseline, Days 1, 2, 8 of Cycle 1, Day 1 of Cycle 2 and Cycle 3, Days 1, 2, 8 of Cycle 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2495655

Administered intravenously (IV) every 2 weeks (14 days) for four (4) 14 day cycles. Participants receiving clinical benefit may continue to receive treatment until one or more of the discontinuation criteria are met.

Starting dose in Part 1 (dose escalation) will be 2 mg. The dose will be subsequently increased to 7 mg, 21 mg, 70 mg, 210 mg, and 700 mg. The dose administered in Part 2 (dose confirmation) will be determined from Part 1.

Drug: LY2495655
administered intravenously

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01524224

Locations
United States, Arizona
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.
Scottsdale, Arizona, United States, 85260
United States, 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.
New York, New York, United States, 10032
United States, Tennessee
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.
Nashville, Tennessee, United States, 37203
United States, Texas
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.
Dallas, Texas, United States, 75246
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.
The Woodlands, Texas, United States, 77380
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.
Tyler, Texas, United States, 75702
United States, Washington
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.
Vancouver, Washington, United States, 98684
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01524224     History of Changes
Other Study ID Numbers: 11207, I1Q-MC-JDDB
Study First Received: January 30, 2012
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Metastases
Neoplasm
Advanced Cancer
Metastatic Cancer

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014