A Study of IMC-3G3 in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01204710
First received: September 16, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: IMC-3G3
Drug: Mitoxantrone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Approximately 21 months ] [ Designated as safety issue: No ]
    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:
  • Overall survival (OS) [ Time Frame: Approximately 21 months ] [ Designated as safety issue: Yes ]
    Overall survival time is measured as randomization to date of death from any cause.

  • Objective Response Rate (ORR) [ Time Frame: Approximately 21 months ] [ Designated as safety issue: No ]
    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.

  • Prostate Specific Androgen (PSA) response rate [ Time Frame: Approximately 21 months ] [ Designated as safety issue: No ]
    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.

  • Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: Approximately 21 months ] [ Designated as safety issue: Yes ]
    Summary listing of Participants Reporting Treatment-Emergent Adverse Events that received IMC-3G3.

  • Circulating Tumor Cells and PDGFRα expression [ Time Frame: Approximately 21 months ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) cycles 1, 2, 3, and 4 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Serum Anti-IMC-3G3 Antibody Assessment (immunogenicity) [ Time Frame: Approximately 21 months ] [ Designated as safety issue: Yes ]
    Screen for the development of circulating antibodies against IMC-3G3


Enrollment: 123
Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204710

  Hide Study Locations
Locations
Belgium
ImClone Investigational Site
Charleroi, Belgium, 6000
ImClone Investigational Site
Edegem, Belgium, 2650
ImClone Investigational Site
Liège, Belgium, 4000
Czech Republic
ImClone Investigational Site
Olomouc, Czech Republic, 77520
ImClone Investigational Site
Prague, Czech Republic, 12808
ImClone Investigational Site
Praha 5, Czech Republic, 15006
Germany
ImClone Investigational Site
Aachen, Germany, 57074
ImClone Investigational Site
Augsburg, Germany, 86150
ImClone Investigational Site
Bonn, Germany, 53177
ImClone Investigational Site
Dresden, Germany, 01307
ImClone Investigational Site
Essen, Germany, 45122
ImClone Investigational Site
Frankfurt, Germany, 60590
ImClone Investigational Site
Freiburg, Germany, 79106
ImClone Investigational Site
Mainz, Germany, 55131
ImClone Investigational Site
Mannheim, Germany, 68167
ImClone Investigational Site
Münster, Germany, 48149
ImClone Investigational Site
Rostock, Germany, 18055
Hungary
ImClone Investigational Site
Budapest, Hungary, 1106
ImClone Investigational Site
Debrecen, Hungary, 4032
ImClone Investigational Site
Kecskemét, Hungary, 6000
ImClone Investigational Site
Miskolc, Hungary, 3526
ImClone Investigational Site
Nyíregyháza, Hungary, 4400
ImClone Investigational Site
Pécs, Hungary, 7624
ImClone Investigational Site
Szeged, Hungary, 6725
Italy
ImClone Investigational Site
Meldola, Italy, 47014
ImClone Investigational Site
Milano, Italy, 20123
ImClone Investigational Site
Roma, Italy, 161
ImClone Investigational Site
Rozzano, Italy, 20089
ImClone Investigational Site
Trento, Italy, 38100
Poland
ImClone Investigational Site
Kraków, Poland, 31-115
ImClone Investigational Site
Lublin, Poland, 20-090
ImClone Investigational Site
Poznań, Poland, 61-485
ImClone Investigational Site
Warszawa, Poland, 02-781
Spain
ImClone Investigational Site
Barcelona, Spain, 8003
ImClone Investigational Site
Barcelona, Spain, 8036
ImClone Investigational Site
Madrid, Spain, 28041
ImClone Investigational Site
Palma de Mallorca, Spain, 7014
ImClone Investigational Site
Pamplona - Navarra, Spain, 31008
ImClone Investigational Site
Sabadell - Barcelona, Spain, 8208
ImClone Investigational Site
Valencia, Spain, 46014
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: NCT01204710     History of Changes
Other Study ID Numbers: 13938, I5B-IE-JGDD, CP15-0805, 2009-018015-11
Study First Received: September 16, 2010
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy

Keywords provided by Eli Lilly and Company:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014