deltatrials
Completed PHASE1 NCT00070616

Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

An Open-label Study of the Pharmacokinetics (PK) of Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF) in Subjects With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy Followed by Peripheral Blood Progenitor Cell (PBPC) Transplantation

Sponsor: Amgen

Conditions Leukemia Lymphoma Myeloma
Interventions Chemotherapy Palifermin 2 x 180 μg/kg/day Palifermin 6 x 60 μg/kg/day radiotherapy
Updated 6 times since 2017 Last updated: Oct 23, 2014 Started: Dec 31, 2001 Primary completion: Mar 31, 2005 Completion: Mar 31, 2005

Listed as NCT00070616, this PHASE1 trial focuses on Leukemia and Lymphoma and remains completed. Sponsored by Amgen, it has been updated 6 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Dec 2001

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
  • Swedish Orphan Biovitrum
Data source: Swedish Orphan Biovitrum

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

Study Locations

No location information available.