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Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 181 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Oct 31, 2026 to Sep 3, 2027 Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 2 of 3 entries · Site details revised at 36 of 419 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 36 of 419 sites
  2. Study sites revised (419)v180 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (419)v179 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 420 to 419v178
  5. Study sites revised (420)v177 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv176
  2. Study sites: 421 to 420v175
  3. Study sites: 423 to 421 Completion date: Oct 31, 2025 to Oct 31, 2026v174 Show 1 more changeShow less
    • Completion date: Oct 31, 2025 to Oct 31, 2026
  4. Study sites revised (423)v173 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (423)v172 See this version in full on ClinicalTrials.gov ↗
  6. Study sites revised (423)v171 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (423)v170 See this version in full on ClinicalTrials.gov ↗
  8. 2 versions Re-verified since Mar 28, 2025, no change to tracked fieldsv168-v169
  9. Study sites revised (423)v167 See this version in full on ClinicalTrials.gov ↗
  10. Study sites revised (423)v166 See this version in full on ClinicalTrials.gov ↗
  11. Re-verified, no change to tracked fieldsv165
  12. Study sites revised (423)v164 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 425 to 423 Eligibility criteria expanded, about 32 wordsv163 Show 1 more changeShow less
    • Eligibility criteria expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  14. Results first posted: Jan 7, 2025 Enrollment target: 36 to 40v162 Show 1 more changeShow less
    • Enrollment target: 36 to 40
  15. Enrollment target: estimated 52 to confirmed 36 Primary completion date changed from estimate of Dec 31, 2024 to Nov 27, 2023 · Completion date: Dec 31, 2024 to Oct 31, 2025v161 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2024 to Nov 27, 2023
    • Completion date: Dec 31, 2024 to Oct 31, 2025
  16. Study sites revised (425)v160 See this version in full on ClinicalTrials.gov ↗
  17. Primary and study completion dates: Oct 1, 2024 to Dec 31, 2024v159
  18. Re-verified, no change to tracked fieldsv158
  19. Study sites revised (425)v157 See this version in full on ClinicalTrials.gov ↗
  20. Study sites revised (425)v156 See this version in full on ClinicalTrials.gov ↗
  21. Study sites revised (425)v155 See this version in full on ClinicalTrials.gov ↗
  22. Study sites revised (425)v154 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (425)v153 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 426 to 425v152
  25. Study sites revised (426)v151 See this version in full on ClinicalTrials.gov ↗
  26. Re-verified, no change to tracked fieldsv150
  27. Study sites revised (426)v149 See this version in full on ClinicalTrials.gov ↗
  28. Study sites revised (426)v148 See this version in full on ClinicalTrials.gov ↗
  29. Primary and study completion dates: Oct 1, 2023 to Oct 1, 2024v147
  30. Start date: Jan 31, 2020 to Mar 16, 2020v146
  31. Re-verified, no change to tracked fieldsv145
  32. Study sites revised (426)v144 See this version in full on ClinicalTrials.gov ↗
  33. Study sites revised (426)v143 See this version in full on ClinicalTrials.gov ↗
  34. Study sites revised (426)v142 See this version in full on ClinicalTrials.gov ↗
  35. Study sites revised (426)v141 See this version in full on ClinicalTrials.gov ↗
  36. Re-verified, no change to tracked fieldsv140
  37. Trial status: Suspended to Active, Not Recruitingv139
  38. Re-verified, no change to tracked fieldsv138
  39. Study sites revised (426)v137 See this version in full on ClinicalTrials.gov ↗
  40. Study sites revised (426)v136 See this version in full on ClinicalTrials.gov ↗
  41. Re-verified, no change to tracked fieldsv135
  42. Study Status, Contacts/Locationsv134
  43. 2 versions Re-verified since Dec 24, 2022, no change to tracked fieldsv132-v133
  • 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.
This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.
Trial Details
NCT Number NCT04175912
Lead Sponsor National Cancer Institute (NCI)
Conditions Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 +7 more
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov