Drugs / Palifermin

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Kepivance — 2016-04-01 europa.eu ↗
Label expansion US (FDA) KEPIVANCE — 2011-11-14 fda.gov ↗
Approved EU (EMA) Kepivance — 2005-10-25 europa.eu ↗
Approved US (FDA) KEPIVANCE — 2004-12-15 fda.gov ↗

Trials 29

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT01163097 Jul 2010 → Jan 2011 mucositis Swedish Orphan Biovitrum Completed No outcome recorded
Phase 1 NCT00701688 Sep 2007 → Sep 2011 mouth disorder St. Jude Children's Research Hospital Completed No outcome recorded
Phase 1 NCT00482846 Jun 2007 → Oct 2011 mucositis, plasma cell myeloma Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
Phase 1 NCT00460421 Aug 2006 → May 2011 leukemia Swedish Orphan Biovitrum Completed No outcome recorded
Phase 1 NCT00361348 Dec 2005 → Jul 2006 — Swedish Orphan Biovitrum Completed No outcome recorded
Phase 1 NCT00070616 Dec 2001 → Mar 2005 leukemia, plasma cell myeloma Swedish Orphan Biovitrum Completed No outcome recorded
Phase 1/25 trials · 1 missed
Phase 1/2 NCT02356159 Sep 2015 → Dec 2024 Hodgkins lymphoma, acute leukemia, myelodysplastic syndrome, non-Hodgkin lymphoma +1 National Cancer Institute (NCI) Completed Missed primary
Phase 1/2 NCT01712945 Jun 2012 → Aug 2017 multiple sclerosis Cambridge University Hospitals NHS Foundation Trust Terminated No outcome recorded
Phase 1/2 NCT02037347 Oct 2010 → Dec 2014 Stevens-Johnson syndrome Brett King Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00540332 Oct 2007 → Sep 2008 head and neck cancer Swedish Orphan Biovitrum Withdrawn No outcome recorded
Phase 1/2 NCT00626639 Jul 2005 → May 2007 head and neck cancer, mucositis Swedish Orphan Biovitrum Completed No outcome recorded
Phase 211 trials · 1 met primary · 3 missed
Phase 2 NCT01746849 Dec 2012 → Dec 2026 expected leukemia, myelodysplastic syndrome, non-Hodgkin lymphoma, plasma cell myeloma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT00728585 Mar 2008 → May 2009 cancer, gastrointestinal mucositis Children's Oncology Group Withdrawn No outcome recorded
Phase 2 NCT00629798 Feb 2008 → Oct 2020 acute myeloid leukemia, myelodysplastic syndrome Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT00570999 Feb 2008 → Jan 2013 acute leukemia, chronic myeloid leukemia, lymphoma, myelodysplastic syndrome +1 European Society for Blood and Marrow Transplantation Withdrawn No outcome recorded
Phase 2 NCT00593554 Aug 2007 → Aug 2016 acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome Sherif S. Farag Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00376935 Dec 2006 → Jul 2008 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 2 NCT00189488 Dec 2005 → Nov 2008 acute graft versus host disease, hematopoietic and lymphoid cell neoplasm Swedish Orphan Biovitrum Completed Missed primary
Phase 2 NCT00267046 Dec 2005 → Jul 2009 chemotherapy-induced oral mucositis, sarcoma M.D. Anderson Cancer Center Completed Met primary
Phase 2 NCT00094861 Jan 2005 → Dec 2007 non-small cell lung carcinoma Swedish Orphan Biovitrum Completed Missed primary
Phase 2 NCT00004132 Jan 2000 → May 2004 chemotherapy-induced oral mucositis, leukemia, plasma cell neoplasm, poisoning +1 Jonsson Comprehensive Cancer Center Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00393822 Aug 2005 → Dec 2007 colon carcinoma Amgen Completed No outcome recorded
Phase 34 trials · 1 met primary
Phase 3 NCT00360971 Jul 2006 → May 2008 head and neck cancer, mucositis, radiation-induced disorder Radiation Therapy Oncology Group Terminated No outcome recorded
Phase 3 NCT00101582 Aug 2005 → Sep 2007 chemotherapy-induced oral mucositis, head and neck cancer, squamous cell carcinoma Swedish Orphan Biovitrum Completed Met primary
Phase 3 NCT00131638 Jan 2005 → Nov 2007 head and neck cancer Amgen Completed No outcome recorded
Phase 3 NCT00109031 Jan 2005 → Feb 2006 cancer, leukemia, lymphoma Swedish Orphan Biovitrum Completed No outcome recorded
Phase not applicable1 trial
— NCT01233921 Sep 2010 → Jul 2012 Burkitt lymphoma, Hodgkins lymphoma, MALT lymphoma, acute myeloid leukemia with 11q23 abnormalities +26 Martin, Paul Completed No outcome recorded
Phase not stated1 trial · 1 missed
— NCT01085617 Dec 2010 → Feb 2025 leukemia, mouth disorder, mucositis University College, London Completed Missed primary
Comparator or background therapy23 trials
Phase 0 NCT00881556 Background Aug 2009 → Sep 2015 epidermolysis bullosa Columbia University Terminated No outcome recorded
Phase 1 NCT05139004 Background Jul 2022 → Jun 2027 expected acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1 NCT04177004 Background Apr 2021 → Dec 2025 overdue disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1 NCT03531281 Background Dec 2018 → Dec 2022 disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm City of Hope Medical Center Withdrawn No outcome recorded
Phase 1 NCT01421173 Background Aug 2011 → Sep 2015 lymphoma M.D. Anderson Cancer Center Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 53 sources stand behind the page.

FieldValueCited text
Known as Palifermin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00361348 ↗
51

NCT00728585 ↗

NCT02313792 ↗

NCT00360971 ↗

NCT00593554 ↗

NCT00109031 ↗

NCT00189488 ↗

NCT00410982 ↗

NCT00004132 ↗

NCT03100877 ↗

NCT01085617 ↗

Show 41 more sources

Known as IND # 6370 “Palifermin (NSC# 740548; IND # 6370)” NCT00360971 ↗
Known as Kepivance “a keratinocyte growth factor (Palifermin or Kepivance®)” NCT00570999 ↗
Known as NSC# 740548 “Palifermin (NSC# 740548; IND # 6370)” NCT00360971 ↗
Known as Recombinant Human Keratinocyte Growth Factor “A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the...” NCT00540332 ↗
1

“Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF)” NCT00070616 ↗

Known as rHuKGF “A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in...” NCT00626639 ↗
4

“A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the...” NCT00540332 ↗

“Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery” NCT00376935 ↗

“palifermin (recombinant human keratinocyte growth factor, rHuKGF)” NCT00393822 ↗

“Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF)” NCT00070616 ↗

Action Activate “cellular proliferation induced by the KGF mitogenic signal” PMID 25880826 ↗ May 2015
Modality Protein / enzyme biologic “recombinant human keratinocyte growth factor (rHuKGF)” NCT00004061 ↗
Route Intravenous “Patients receive recombinant human keratinocyte growth factor (rHuKGF) IV on days -11 to -9, -5, and 0 to 2.” NCT00004061 ↗