Phase 2
N=180
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Prostate Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT01360840 ↗Enrolled (actual)
180
Serious AEs
24.2%
Results posted
Dec 2015
Primary outcome: Primary: Progression Free Survival (PFS) Time — 3.3; 3.4; 4.3 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EMD 525797 (Drug); Placebo (Other); Standard of Care (SoC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- EMD Serono
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Time |
3.3; 3.4; 4.3 | — |
| SECONDARY Overall Survival |
NA; NA; NA | — |
| SECONDARY Time to Tumor Progression |
3.3; 3.4; 4.6 | — |
| SECONDARY Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions |
1; 0; 1; 2; 3; 4 | — |
| SECONDARY Number of Subjects With New Bone Lesions Compared to Baseline |
40; 34; 34 | — |
| SECONDARY Number of Subjects With Presence of DC in Bone Lesions |
4; 7; 7; 2; 7; 6 | — |
| SECONDARY Bone and Soft Tissue Lesions Composite Tumor Response |
0; 0; 0 | — |
| SECONDARY Number of Subjects With Presence of Skeletal Related Events |
2; 8; 3 | — |
| SECONDARY Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response |
3; 6; 5 | — |
| SECONDARY Minimum Percentage Change From Baseline in PSA Serum Concentration |
24.00; 35.65; 14.70 | — |
| SECONDARY Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs) |
49.02; 354.74; 280.58 | — |
| SECONDARY Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC) |
9.54; 223.97; 179.11 | — |
| SECONDARY Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation |
55; 49; 53; 16; 13; 14 | — |
| SECONDARY Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss) |
0.017; 0.013; 0.017; 0.010 | — |
| SECONDARY Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion |
4.55; 4.60; 4.81; 5.18 | — |
Summary
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score)
- Bisphosphonate treatment
- Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
- Chronic and ongoing treatment with opioids
- Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
- Visceral metastasis, brain metastasis
- Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT01360840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.