Clinical trial · Interventional
A Study of Olaratumab (IMC-3G3) in Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Olaratumab | Biological | Olaratumab | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Olaratumab + Mitoxantrone
- description
- 1 cycle = 3 weeks (21 days)
- interventionNames
- Biological: Olaratumab
- Drug: Mitoxantrone
- Drug: Prednisone
- type
- ACTIVE_COMPARATOR
- label
- Mitoxantrone: Optional Olaratumab Monotherapy
- description
- 1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
- interventionNames
- Drug: Mitoxantrone
- Drug: Prednisone
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available