Clinical trial · Interventional
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
- 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)
The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Castrate-Resistant Prostate Cancer | — | UNRESOLVED | — |
| Mestastatic Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 102 | Drug | Rilotumumab | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Phase 1b - AMG 102
- description
- Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP.
- interventionNames
- Drug: AMG 102
- Drug: Mitoxantrone
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- Phase 2 Arm A - AMG 102 + MP
- description
- AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.
- interventionNames
- Drug: AMG 102
- Drug: Mitoxantrone
- Drug: Prednisone
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the prostate * Radiographic evidence of metastatic disease * Progressive disease meeting at least one of the following criteria: 1. a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or 2. progression according to RECIST criteria for measurable lesions, or 3. appearance of 2 or more new lesions on bone scan. * History of prior taxane-based chemotherapy for metastatic prostate cancer * For patients without a history of surgical castration, continued GnRH analog administration is required * ECOG Performance status of 0 or 1 * Life expectancy ≥ 3 months Exclusion Criteria: * Treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks * ≤ 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and \<6 weeks since receipt of prior bevacizumab. * Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area). * Significant cardiovascular disease * LVEF \< 50% by MUGA or ECHO * Treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection) * Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed * Major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery * Presence of peripheral edema \> Grade 2 * Known positive test for HIV, hepatitis C, chronic or active hepatitis B * Serious or non-healing wound * Unable to begin protocol specified treatment within 7 days after enrollment * Other investigational procedures are excluded.
References
Publications (2)
- BACKGROUNDOliner K.BM Ph2 CRPC.Journal-004521;
- BACKGROUNDRyan CJ, Rosenthal M, Ng S, Alumkal J, Picus J, Gravis G, Fizazi K, Forget F, Machiels JP, Srinivas S, Zhu M, Tang R, Oliner KS, Jiang Y, Loh E, Dubey S, Gerritsen WR. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res. 2013 Jan 1;19(1):215-24. doi: 10.1158/1078-0432.CCR-12-2605. Epub 2012 Nov 7. PMID 23136195