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SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

Study acronym: SHARON
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment target: 10 to 24v19 Show 8 more changesShow less
    • Primary completion date: Aug 2026 to Dec 2028
    • Primary endpoints: 13 to 14
    • Study completion date: Aug 2027 to Dec 2028
    • Interventions: Autologous Hematopoietic Stem Cells (Device), BCNU (Drug), Ethanol (Drug), Melphalan (Drug), Vitamin B12B (Drug), Vitamin C (Drug) to Autologous Hematopoietic Stem Cells (Device), BCNU (Drug), Melphalan (Drug), Vitamin B12B (Drug), Vitamin C (Drug)
    • Eligibility criteria expanded, about 126 words
    • Study description shortened, about 24 words
    • Site details revised at 1 of 2 sites
    • Study title shortened, about 6 words
  2. Primary completion date: Dec 2025 to Aug 2026
    • Study completion date: Dec 2025 to Aug 2027
    v18
  3. Eligibility criteria shortened, about 52 words
    • Site details revised at 1 of 2 sites
    v17
  4. Primary and study completion dates: Dec 2024 to Dec 2025
    • Eligibility criteria expanded, about 168 words
    • Study title shortened, about 1 word
    v16
  5. Primary and study completion dates: May 2024 to Dec 2024v15 Show 5 more changesShow less
    • Primary endpoints revised (13)
    • Eligibility criteria expanded, about 57 words
    • Site contacts updated at 2 of 2 sites
    • Study description expanded, about 4 words
    • Study title shortened, about 1 word
Show 13 earlier versionsHide 13 earlier versions
  1. Collaborators expanded, about 3 wordsv14
  2. Primary and study completion dates: Dec 2023 to May 2024
    • Eligibility criteria shortened, about 1 word
    v13
  3. Site details revised at 1 of 2 sitesv12
  4. Primary completion date: Nov 2022 to Dec 2023v11 Show 4 more changesShow less
    • Study completion date: May 2023 to Dec 2023
    • Eligibility criteria expanded, about 12 words
    • Study description shortened, about 46 words
    • Site contacts updated at 2 of 2 sites
  5. Study sites: 1 to 2v10 Show 4 more changesShow less
    • Primary completion date: Jul 2022 to Nov 2022
    • Study completion date: Jan 2023 to May 2023
    • Eligibility criteria shortened, about 281 words
    • Study description revised
  6. Primary completion date: Feb 2022 to Jul 2022
    • Study completion date: Aug 2022 to Jan 2023
    • Eligibility criteria expanded, about 10 words
    v9
  7. Eligibility criteria expanded, about 10 wordsv8
  8. Site contact updated
    • Study title expanded, about 4 words
    v7
  9. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Jan 2022 to Feb 2022
    • Study completion date: Jul 2022 to Aug 2022
    • Start date changed from estimate of Dec 2020 to Jan 13, 2021
    • Site details revised
  10. Phase: Phase 2 to Phase 1v5 Show 5 more changesShow less
    • Start date: Oct 2020 to Dec 2020
    • Primary completion date: Nov 2021 to Jan 2022
    • Study completion date: May 2022 to Jul 2022
    • Secondary endpoints: 8 to 14
    • Eligibility criteria shortened, about 2 words
  11. Primary completion date: Sep 2021 to Nov 2021v4 Show 5 more changesShow less
    • Study completion date: Mar 2022 to May 2022
    • Start date: Sep 2020 to Oct 2020
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 16 to 8
    • Study title shortened, about 2 words
  12. Eligibility criteria shortened, about 34 wordsv3
  13. Primary completion date: Sep 2026 to Sep 2021v2 Show 8 more changesShow less
    • Start date: Mar 2020 to Sep 2020
    • Primary endpoints: 29 to 13
    • Enrollment target: 12 to 10
    • Study completion date: Sep 2026 to Mar 2022
    • Interventions: BCNU (Drug), CliniMACS-Enriched CD34+ Autologous Hematopoietic Stem Cells (Device), Ethanol (Drug), Melphalan (Drug), Vitamin B12B (Drug)… to Autologous Hematopoietic Stem Cells (Device), BCNU (Drug), Ethanol (Drug), Melphalan (Drug), Vitamin B12B (Drug), Vitamin C (Drug)
    • Eligibility criteria expanded, about 168 words
    • Secondary endpoints: 10 to 16
    • Study description expanded, about 10 words
  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.
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.
Trial Details
NCT Number NCT04150042
Lead Sponsor General Oncology, Inc.
Collaborators: Myriad Genetics, Inc.
Conditions
(from sponsor)		 Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma +12 more
Related terms Breast Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms, Recurrence
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov