A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

StatusRecruiting
PhasePhase 1
SponsorPfizer
Started

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Record History

The 50 most recent of 136 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (85)
  2. Interventions modified
  3. Study sites: 84 to 85
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 10 entries
  4. Study sites: 82 to 84v133
  5. Study sites: 83 to 82v132
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (83)v131
  2. Site details revised at 1 of 83 sitesv130
  3. Study sites: 82 to 83v129
  4. Site details revised at 5 of 82 sitesv128
  5. Re-verified, no change to tracked fieldsv127
  6. Study sites: 81 to 82v126
  7. Study sites: 82 to 81v125
  8. Enrollment target: 433 to 453v124 Show 5 more changesShow less
    • Primary completion date: May 1, 2028 to Apr 20, 2028
    • Study completion date: Mar 14, 2029 to Jul 7, 2029
    • Interventions: Enzalutamide (Drug), Mervometostat (PF-06821497) (Drug) to Enzalutamide (Drug), Itraconazole (Drug), Mervometostat (PF-06821497) (Drug)
    • Study description expanded, about 12 words
    • Site details revised at 12 of 82 sites
  9. Site details revised at 1 of 82 sitesv123
  10. Study sites: 83 to 82v122
  11. Study sites: 86 to 83v121
  12. Re-verified, no change to tracked fieldsv120
  13. Study sites revised (86)v119
  14. Study sites: 102 to 86v118
  15. Primary completion date: Mar 19, 2026 to May 1, 2028v117 Show 7 more changesShow less
    • Enrollment target: 343 to 433
    • Study sites: 104 to 102
    • Study completion date: Mar 19, 2026 to Mar 14, 2029
    • Eligibility criteria shortened, about 268 words
    • Study description shortened, about 38 words
    • Study arms: 8 to 10
    • Study title expanded, about 4 words
  16. Study sites: 103 to 104v116
  17. Study sites: 84 to 103v115
  18. Study sites: 85 to 84v114
  19. Study sites revised (85)v113
  20. Re-verified, no change to tracked fieldsv112
  21. Study sites: 83 to 85v111
  22. Study sites: 89 to 83v110
  23. Study sites: 92 to 89
    • Primary and study completion dates: Dec 9, 2025 to Mar 19, 2026
    v109
  24. Study sites: 103 to 92v108
  25. Site details revised at 1 of 103 sitesv107
  26. Site details revised at 1 of 103 sitesv106
  27. Primary endpoints: 5 to 6v105 Show 9 more changesShow less
    • Enrollment target: 267 to 343
    • Primary and study completion dates: Oct 24, 2025 to Dec 9, 2025
    • Interventions: PF-06821497 (Drug) to Enzalutamide (Drug), Mervometostat (PF-06821497) (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 9 to 10
    • Study description shortened, about 26 words
    • Site details revised at 2 of 103 sites
    • Study title revised
    • Study arms: 7 to 8
  28. Site details revised at 3 of 103 sitesv104
  29. Site details revised at 2 of 103 sitesv103
  30. Site details revised at 1 of 103 sitesv102
  31. Site details revised at 2 of 103 sitesv101
  32. Study sites: 102 to 103v100
  33. Study sites: 101 to 102v99
  34. Re-verified, no change to tracked fieldsv98
  35. Study sites: 100 to 101v97
  36. Study sites: 96 to 100v96
  37. Study sites: 95 to 96v95
  38. Study sites: 93 to 95v94
  39. Site details revised at 3 of 93 sitesv93
  40. Study sites: 92 to 93v92
  41. Study sites: 91 to 92v91
  42. Study sites: 87 to 91v90
  43. Study sites: 79 to 87
    • Primary and study completion dates: Nov 23, 2025 to Oct 24, 2025
    v89
  44. Primary and study completion dates: Apr 13, 2025 to Nov 23, 2025
    • Study sites: 73 to 79
    v88
  45. Enrollment target: 185 to 267
    • Study sites: 72 to 73
    • Primary and study completion dates: Jan 12, 2025 to Apr 13, 2025
    v87
  • 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.
Pfizer
438 trials monitored
See 32 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Prostate Cancer
2,550 trials monitored
See 165 trials at risk
Non-Hodgkin Lymphoma
2,017 trials monitored
See 114 trials at risk
and 2 more diseases
The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment. Part 3, which is open for enrollment is seeking men who: * have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort). In the assessment phase: * participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule. * participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule. After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding. The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.
Trial Details
NCT Number NCT03460977
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Metastatic Castration Resistant Prostate Cancer (mCRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL)
Related terms Lymphoma, Follicular, Recurrence, Small Cell Lung Carcinoma
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov