deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01794793

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

Sponsor: RECORDATI GROUP

Conditions Acromegaly Cushing's Disease Dumping Syndrome Ectopic ACTH Secreting (EAS) Tumors Melanoma Negative for bRAF Melanoma Negative for nRAS Neuroendocrine Tumors Pituitary Tumors Prostate Cancer
Interventions Cabergoline Pasireotide Pasireotide LAR
Updated 30 times since 2017 Last updated: Sep 16, 2024 Started: Jun 10, 2013 Primary completion: Jul 25, 2023 Completion: Jul 25, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Acromegaly and Cushing's Disease, this trial is completed. The trial is conducted by RECORDATI GROUP and has accumulated 30 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected. A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment. The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected.

A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment.

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2018 · 13 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Jun 2020 · 2 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshot~Jun 2022 – ~Jun 2024 · 24 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · 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 – ~Sep 2025 · 11 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot

Change History

30 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Oct 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE4

  4. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE4

  5. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE4

    Status: Unknown Status → Completed

▶ Show 25 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Unknown Status PHASE4

    Status: Active Not Recruiting → Unknown Status

  2. Jun 2022 — Jun 2024 [monthly]

    Active Not Recruiting PHASE4

  3. Jan 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE4

  4. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

  5. Oct 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE4

  6. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

  7. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE4

  8. Apr 2020 — Jun 2020 [monthly]

    Recruiting PHASE4

  9. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE4

  10. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE4

  11. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE4

  12. Oct 2019 — Dec 2019 [monthly]

    Recruiting PHASE4

  13. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE4

  14. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE4

  15. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE4

  16. Mar 2019 — May 2019 [monthly]

    Recruiting PHASE4

  17. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE4

  18. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE4

  19. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE4

  20. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE4

  21. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE4

  22. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  23. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE4

  24. Feb 2017 — Mar 2018 [monthly]

    Recruiting PHASE4

  25. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE4

    First recorded

Jun 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • RECORDATI GROUP
Data source: RECORDATI GROUP

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

Study Locations

Alicante, Spain , Ancona, Italy , Angers, France , Ankara, Turkey (Türkiye) , Ann Arbor, United States , Antalya, Turkey (Türkiye) , Athens, Greece , Bangalore, India , Bangkok, Thailand , Barcelona, Spain and 77 more locations