Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

StatusCompleted
PhasePhase 2
SponsorPfizer
Started

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Record History

The 50 most recent of 75 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Oct 7, 2026
    • Trial completed
    • Trial sites reduced: 101 → 84 locations
    • Study completion date changed from estimate of Oct 18, 2025 to Aug 6, 2025
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 36 to 31
    • Collaborators: details revised at 1 of 1 entry
  2. Study sites: 144 to 101v74
  3. Phase: Phase 1/2 to Phase 2
    • Primary completion date changed from estimate of Aug 19, 2024 to Aug 26, 2024
    • Study completion date: Feb 25, 2025 to Oct 18, 2025
    v73
  4. 2 versions Re-verified since Jul 24, 2024, no change to tracked fieldsv71-v72
  5. Primary completion date: Jun 24, 2024 to Aug 19, 2024v70
Show 44 earlier versionsHide 44 earlier versions
  1. 2 versions Re-verified since Mar 25, 2024, no change to tracked fieldsv68-v69
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 184 to confirmed 128
    • Study sites: 145 to 144
    • Primary completion date: Aug 30, 2024 to Jun 24, 2024
    v67
  3. Phase: Phase 2 to Phase 1/2
    • Primary completion date: Feb 29, 2024 to Aug 30, 2024
    • Study sites: 143 to 145
    v66
  4. Phase: Phase 1/2 to Phase 2
    • Study sites: 142 to 143
    • Primary completion date: Jul 28, 2024 to Feb 29, 2024
    • Study completion date: Mar 15, 2025 to Feb 25, 2025
    v65
  5. Study sites: 140 to 142v64
  6. Phase: Phase 2 to Phase 1/2
    • Study sites: 138 to 140
    • Eligibility criteria expanded, about 252 words
    • Study arms: 3 to 4
    v63
  7. Study sites: 131 to 138v62
  8. Study sites: 123 to 131v61
  9. Site details revised at 1 of 123 sitesv60
  10. Phase: Phase 1/2 to Phase 2
    • Study sites: 114 to 123
    v59
  11. Phase: Phase 2 to Phase 1/2
    • Study sites: 108 to 114
    v58
  12. Phase: Phase 1/2 to Phase 2
    • Site details revised at 2 of 108 sites
    v57
  13. Phase: Phase 2 to Phase 1/2
    • Study sites: 103 to 108
    v56
  14. Study sites: 93 to 103v55
  15. Study sites: 89 to 93v54
  16. Study sites: 84 to 89v53
  17. Phase: Phase 1/2 to Phase 2
    • Study sites: 82 to 84
    v52
  18. Phase: Phase 2 to Phase 1/2v51 Show 6 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 58 to 82
    • Primary completion date: Apr 20, 2024 to Jul 28, 2024
    • Study completion date: Dec 6, 2024 to Mar 15, 2025
    • Eligibility criteria shortened, about 148 words
    • Secondary endpoints: 35 to 36
  19. Enrollment target: 167 to 184
    • Primary completion date: Feb 9, 2024 to Apr 20, 2024
    • Study completion date: Sep 26, 2024 to Dec 6, 2024
    • Study sites revised (58)
    v50
  20. Collaborators expanded, about 3 wordsv49
  21. Phase: Phase 1 to Phase 2v48 Show 8 more changesShow less
    • Primary completion date: Nov 29, 2021 to Feb 9, 2024
    • Primary endpoints: 3 to 4
    • Enrollment target: 133 to 167
    • Study sites: 57 to 58
    • Study completion date: Jan 13, 2025 to Sep 26, 2024
    • Eligibility criteria expanded, about 161 words
    • Secondary endpoints: 33 to 35
    • Study arms: 1 to 3
  22. Site details revised at 1 of 57 sitesv47
  23. Site details revised at 24 of 57 sitesv46
  24. Primary completion date: Dec 3, 2021 to Nov 29, 2021
    • Study completion date: Jan 21, 2025 to Jan 13, 2025
    • Study sites revised (57)
    v45
  25. Primary completion date: Feb 16, 2021 to Dec 3, 2021v44 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 100 to 133
    • Study sites: 61 to 57
    • Study completion date: May 15, 2024 to Jan 21, 2025
    • Interventions: Irinotecan (Drug), Palbociclib (Drug), Temozolomide (Drug) to Cyclophosphamide (Drug), Irinotecan (Drug), Palbociclib (Drug), Temozolomide (Drug), Topotecan (Drug)
    • Eligibility criteria expanded, about 106 words
    • Secondary endpoints: 23 to 33
  26. Primary completion date: Dec 19, 2022 to Feb 16, 2021
    • Study sites: 57 to 61
    • Study completion date: Apr 28, 2024 to May 15, 2024
    v43
  27. Study sites: 52 to 57
    • Study completion date: Dec 3, 2023 to Apr 28, 2024
    v42
  28. Study sites: 48 to 52
    • Study completion date: Nov 16, 2023 to Dec 3, 2023
    v41
  29. Study sites: 47 to 48v40
  30. Site details revised at 1 of 47 sitesv39
  31. Study sites: 43 to 47v38
  32. Study completion date: Dec 3, 2023 to Nov 16, 2023
    • Site details revised at 4 of 43 sites
    v37
  33. Study sites: 40 to 43v36
  34. Study sites: 38 to 40v35
  35. Study sites: 34 to 38
    • Study completion date: Nov 16, 2023 to Dec 3, 2023
    v34
  36. Study sites: 31 to 34v33
  37. Study sites: 27 to 31v32
  38. Study sites: 25 to 27v31
  39. Eligibility criteria expanded, about 51 words
    • Secondary endpoints revised (23)
    v30
  40. Study Status, Contacts/Locations, Referencesv29
  41. Study Status, Contacts/Locationsv28
  42. Study Status, Contacts/Locationsv27
  43. Study Status, Contacts/Locationsv26
  • 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
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A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
Trial Details
NCT Number NCT03709680
Lead Sponsor Pfizer
Collaborators: Children's Oncology Group
Conditions
(from sponsor)		 Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
Related terms Bone Neoplasms, Diffuse Intrinsic Pontine Glioma, Medulloblastoma, Neoplasms, Neuroblastoma, Rhabdoid Tumor, Rhabdomyosarcoma, Sarcoma, Sarcoma, Ewing
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov