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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 298 to 299
  2. Study sites revised (298)
  3. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Study sites: 296 to 298 · Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 5 of 9 entries Show 3 more changesShow less
    • Study sites: 296 to 298
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 5 of 9 entries
  4. Site details revised at 1 of 296 sitesv45
  5. Study sites: 295 to 296v44
Show 42 earlier versionsHide 42 earlier versions
  1. Study sites: 294 to 295v43
  2. Study sites: 292 to 294v42
  3. Study sites: 291 to 292v41
  4. Study sites: 290 to 291v40
  5. Site details revised at 2 of 290 sitesv39
  6. Study sites revised (290)v38 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 288 to 290v37
  8. Study sites: 286 to 288v36
  9. Study sites: 285 to 286v35
  10. Study sites: 284 to 285v34
  11. Study sites: 283 to 284v33
  12. Study sites: 282 to 283v32
  13. Study sites: 281 to 282v31
  14. Site details revised at 2 of 281 sitesv30
  15. Study sites: 280 to 281v29
  16. Study sites: 279 to 280v28
  17. Study sites: 277 to 279v27
  18. Re-verified, no change to tracked fieldsv26
  19. Study sites: 275 to 277v25
  20. Study sites: 274 to 275v24
  21. Study sites: 273 to 274 Interventions: Docetaxel (Drug), Ifinatamab deruxtecan (Drug), Prednisone (Drug) to Docetaxel (Drug), Ifinatamab deruxtecan (Drug), Prednisone (Drug), Rescue Medication (Drug) · Eligibility criteria expanded, about 158 words · Secondary endpoints revised (9)v23 Show 3 more changesShow less
    • Interventions: Docetaxel (Drug), Ifinatamab deruxtecan (Drug), Prednisone (Drug) to Docetaxel (Drug), Ifinatamab deruxtecan (Drug), Prednisone (Drug), Rescue Medication (Drug)
    • Eligibility criteria expanded, about 158 words
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  22. Study sites: 272 to 273v22
  23. Study sites: 267 to 272v21
  24. Study sites: 265 to 267v20
  25. Study sites: 263 to 265v19
  26. Study sites: 260 to 263v18
  27. Study sites: 256 to 260v17
  28. Study sites: 253 to 256v16
  29. Study sites: 250 to 253v15
  30. Study sites: 249 to 250v14
  31. Re-verified, no change to tracked fieldsv13
  32. Study sites: 246 to 249v12
  33. Study sites: 244 to 246v11
  34. Study sites: 243 to 244v10
  35. Study sites: 242 to 243v9
  36. Study sites: 216 to 242v8
  37. Study sites: 137 to 216v7
  38. Study sites: 24 to 137v6
  39. Study sites: 22 to 24v5
  40. Study sites: 9 to 22v4
  41. Study sites: 7 to 9v3
  42. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7v2 Show 1 more changeShow less
    • Study sites: 0 to 7
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck (MSD)
407 trials monitored
See 29 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Trial Details
NCT Number NCT06925737
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Prostate Cancer, Prostatic Neoplasms
Enrollment 1,440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov