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Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 89 to confirmed 83
    • Site details revised at 3 of 3 sites
    v22
  2. Minor Site details revised at 1 of 3 sitesv21
  3. Minor Eligibility criteria expanded, about 25 wordsv20
  4. Minor Study sites: 1 to 3v19
  5. Notable Primary and study completion dates: Sep 30, 2027 to Mar 31, 2028v18
Show 16 earlier versionsHide 16 earlier versions
  1. Notable Primary and study completion dates: Jul 31, 2025 to Sep 30, 2027
    • Study description expanded, about 9 words
    v17
  2. Minor Eligibility criteria expanded, about 21 words
    • Study description revised
    v16
  3. Notable Enrollment target: 59 to 89v15 Show 9 more changesShow less
    • Primary and study completion dates: Dec 31, 2023 to Jul 31, 2025
    • Primary endpoints: 3 to 4
    • Interventions: ATR Kinase Inhibitor AZD6738 (Drug), Olaparib (Drug) to Ceralasertib (Drug), Durvalumab (Drug), Olaparib (Drug)
    • Eligibility criteria expanded, about 359 words
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 375 words
    • Site contact updated
    • Study arms: 2 to 3
    • Study title expanded, about 4 words
  4. Minor Eligibility criteria expanded, about 2 wordsv14
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 50 to 59
    • Site details revised
    v13
  6. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 68 to confirmed 50
    • Site details revised
    v12
  7. Notable Primary completion date: Mar 19, 2021 to Dec 31, 2023
    • Study completion date: Mar 19, 2023 to Dec 31, 2023
    v11
  8. Notable Primary endpoints: 1 to 3
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints reordered
    v10
  9. Minor Site contact updatedv9
  10. Notable Primary endpoint revised
    • Eligibility criteria expanded, about 156 words
    • Secondary endpoints revised (6)
    v8
  11. Notable Lead sponsor: University of California, San Francisco to Rahul Aggarwal
    • Eligibility criteria expanded, about 20 words
    • Study site revised
    • Collaborators expanded, about 1 word
    v7
  12. Notable Start date: Dec 15, 2018 to Jan 17, 2019v6
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2018 to Dec 15, 2018
    • Site details revised
    v5
  14. Notable Start date: Oct 1, 2018 to Dec 1, 2018v4
  15. Minor Collaborators shortened, about 4 wordsv3
  16. Minor Study title shortened, about 7 wordsv2
  1. Minor 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.
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and 2 more diseases
This phase II trial studies how well ceralasertib, am Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor, works alone or in combination with olaparib or durvalumab in treating participants with renal cell carcinoma (RCC), urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib or durvalumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib or durvalumab may work better in treating participants with solid tumors.
Trial Details
NCT Number NCT03682289
Lead Sponsor Rahul Aggarwal
Collaborators: AstraZeneca
Conditions
(from sponsor)
Clear Cell Renal Cell Carcinoma, Locally Advanced Pancreatic Cancer, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Renal Cell Carcinoma, Metastatic Urothelial Carcinoma, Metastatic Pancreatic Cancer, Stage III Pancreatic Cancer +5 more
Related terms Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Endometrial Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov