deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT01638533

Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

A Phase 1 and Pharmacokinetic Single Agent Study of Romidepsin in Patients With, Lymphomas, Chronic Lymphocytic Leukemia, and Select Solid Tumors and Varying Degrees of Liver Dysfunction

Sponsor: Celgene Corporation

Conditions Glioma Hematopoietic and Lymphoid Cell Neoplasm Lymphoma Metastatic Malignant Solid Neoplasm Neuroendocrine Neoplasm Recurrent Adult Soft Tissue Sarcoma Recurrent Bladder Carcinoma Recurrent Breast Carcinoma Recurrent Chronic Lymphocytic Leukemia Recurrent Colorectal Carcinoma Recurrent Head and Neck Carcinoma Recurrent Lung Carcinoma Recurrent Malignant Solid Neoplasm Recurrent Melanoma Recurrent Pancreatic Carcinoma Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma Recurrent Prostate Carcinoma Recurrent Renal Cell Carcinoma Recurrent Thyroid Gland Carcinoma Refractory Chronic Lymphocytic Leukemia Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma Stage III Breast Cancer AJCC v7 Stage III Colorectal Cancer AJCC v7 Stage III Cutaneous Melanoma AJCC v7 Stage III Lung Cancer AJCC v7 Stage III Pancreatic Cancer AJCC v6 and v7 Stage III Prostate Cancer AJCC v7 Stage III Renal Cell Cancer AJCC v7 Stage III Soft Tissue Sarcoma AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIA Colorectal Cancer AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIB Colorectal Cancer AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IIIC Colorectal Cancer AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Stage IV Colorectal Cancer AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Stage IV Lung Cancer AJCC v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Stage IV Prostate Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Unresectable Solid Neoplasm
Interventions Pharmacological Study Romidepsin
Updated 43 times since 2017 Last updated: Feb 6, 2025 Started: Aug 3, 2012 Primary completion: Nov 29, 2018 Completion: Sep 1, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01638533, this PHASE1 trial focuses on Glioma and Hematopoietic and Lymphoid Cell Neoplasm and remains completed. Sponsored by Celgene Corporation, it has been updated 43 times since 2012, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~May 2019 · 10 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Dec 2020 · 5 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Jan 2022 · 7 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshot~Feb 2023 – ~Nov 2023 · 9 months · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Mar 2025 · 4 months · monthly snapshot~Mar 2025 – present · 16 months · monthly snapshot

Change History

43 versions recorded

  1. Mar 2025 — Present [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  2. Nov 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1

  3. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 38 earlier versions

  1. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Dec 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  5. Feb 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Nov 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  7. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

  8. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  9. Apr 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  10. Jan 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

  11. Jun 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE1

  12. Apr 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE1

  13. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE1

  14. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  15. Jul 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE1

  16. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  17. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE1

  18. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE1

  19. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  20. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1

  21. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

  22. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  23. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  24. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE1

  25. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1

  26. Jun 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE1

  27. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  28. Jul 2018 — May 2019 [monthly]

    Recruiting PHASE1

  29. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1

  30. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  31. Dec 2017 — Apr 2018 [monthly]

    Recruiting PHASE1

  32. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  33. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE1

  34. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE1

  35. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE1

  36. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE1

  37. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

  38. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Aug 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Celgene Corporation
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Baltimore, United States , Bethesda, United States , Chicago, United States , Cleveland, United States , Detroit, United States , Duarte, United States , Hershey, United States , Philadelphia, United States , Rochester, United States and 2 more locations