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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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 NCI CTCAE v 4.02

- patient has an 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

Approximately 21 months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13938

NCT ID:

NCT01204710

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms

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