A Study of Olaratumab (IMC-3G3) in Prostate Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Prednisone; Drug: Mitoxantrone; Biological: Olaratumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204710

13938

2009-018015-11 (EudraCT Number)

CP15-0805 (Other Identifier)

I5B-IE-JGDD (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 nanograms per milliliter (ng/mL)
• has had disease progression or intolerance on docetaxel-based therapy
• prostate-specific antigen (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) version (v) 4.02
• participant 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 participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
• prior therapy with mitoxantrone for advanced prostate cancer
• The participant 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 platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR)
• known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone
• radiotherapy within 21 days prior to first dose of olaratumab
• any investigational therapy within 30 days of randomization
• is receiving corticosteroids at a dose >5 mg prednisone PO 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Olaratumab + Mitoxantrone

Experimental group

Description:

1 cycle = 3 weeks (21 days)

Treatment:

Biological: Olaratumab

Drug: Mitoxantrone

Drug: Prednisone

Mitoxantrone: Optional Olaratumab Monotherapy

Active Comparator group

Description:

1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.

Treatment:

Drug: Mitoxantrone

Drug: Prednisone