A Study of IMC-3G3 in 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. Identifier: NCT01204710
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : February 17, 2014
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a study evaluating the safety and efficacy of the monoclonal antibody IMC-3G3 plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: IMC-3G3 Drug: Mitoxantrone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy
Study Start Date : October 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IMC-3G3 + Mitoxantrone
1 cycle = 3 weeks (21 days)
Biological: IMC-3G3
15mg/kg I.V. Days 1 and 8
Other Names:
  • Olaratumab
  • LY3012207
Drug: Mitoxantrone

Mitoxantrone 12 mg/m2 I.V. Day 1

Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2)

Active Comparator: Mitoxantrone
1 cycle = 3 weeks (21 days)
Drug: Mitoxantrone

Mitoxantrone 12 mg/m2 I.V. Day 1

Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m2)

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Approximately 21 months ]
    PFS is measured from randomization to the earliest date of the following events: tumor progression according to RECIST v.1.1, unequivocal evidence of progression by bone scan, clinical progression, or death from any cause.

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 21 months ]
    Overall survival time is measured as randomization to date of death from any cause.

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 21 months ]
    Proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) compared to the total number of participants. Best response is categorized using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.

  3. Prostate Specific Androgen (PSA) response rate [ Time Frame: Approximately 21 months ]
    Proportion of participants with a decrease in PSA from pretreatment to any time point, requiring confirmation no less than 3 weeks after the initial suggestion of response and occuring prior to documentation of PD. Additionally, a PSA response rate equal to the proportion of participants with a decrease in PSA from pretreatment to week 12 or earlier for those who discontinue therapy.

  4. Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: Approximately 21 months ]
    Summary listing of Participants Reporting Treatment-Emergent Adverse Events that received IMC-3G3.

  5. Circulating Tumor Cells and PDGFRα expression [ Time Frame: Approximately 21 months ]
  6. Maximum concentration (Cmax) cycles 1, 2, 3, and 4 [ Time Frame: Day 1 ]
  7. Serum Anti-IMC-3G3 Antibody Assessment (immunogenicity) [ Time Frame: Approximately 21 months ]
    Screen for the development of circulating antibodies against IMC-3G3

Information from the National Library of Medicine

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

Inclusion Criteria:

  • histologically-confirmed adenocarcinoma of the prostate
  • radiographic evidence of metastatic prostate cancer (stage M1 or D2)
  • has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL
  • has had disease progression or intolerance on docetaxel-based therapy
  • PSA ≥ 10 ng/mL
  • all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤ Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.02
  • patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • adequate hematologic function
  • adequate hepatic function
  • adequate renal function
  • urinary protein is ≤ 1 on dipstick or routine analysis
  • life expectancy of more than 3 months
  • fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
  • signed Informed Consent document

Exclusion Criteria:

  • concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
  • The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
  • prior therapy with mitoxantrone for advanced prostate cancer
  • The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥ 10% below the lower limit of normal institutional range
  • history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors
  • known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone
  • radiotherapy within 21 days prior to first dose of IMC-3G3
  • any investigational therapy within 30 days of randomization
  • is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent
  • received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
  • has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
  • known or suspected brain or leptomeningeal metastases
  • known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

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 identifier (NCT number): NCT01204710

  Show 40 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company Identifier: NCT01204710     History of Changes
Other Study ID Numbers: 13938
I5B-IE-JGDD ( Other Identifier: Eli Lilly and Company )
CP15-0805 ( Other Identifier: ImClone Systems )
2009-018015-11 ( EudraCT Number )
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: January 2014

Keywords provided by Eli Lilly and Company:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action