NCT00516828 is a Phase 1, PHASE2 clinical trial of cytarabine in Leukemia, sponsored by NCIC Clinical Trials Group.

Who is sponsoring NCT00516828?

NCT00516828 is sponsored by NCIC Clinical Trials Group.

What drugs are being tested in NCT00516828?

Interventions in NCT00516828: cytarabine.

What condition does NCT00516828 study?

NCT00516828 studies Leukemia, Myelodysplastic Syndromes.

Is NCT00516828 still recruiting?

NCT00516828 is currently completed. Last updated 4 August 2023.

Last reviewed 2023-08-04 · How we verify

NCT00516828

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed Phase 1, PHASE2 Last updated 4 August 2023

What this trial tests

Phase 1, PHASE2 trial testing cytarabine in Leukemia in 21 participants. Completed in 10 January 2013.

Timeline

27 November 2007

Primary endpoint
18 March 2010

10 January 2013

Quick facts

Lead sponsor	NCIC Clinical Trials Group
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	27 November 2007
Primary completion	18 March 2010
Estimated completion	10 January 2013
Sites	4 locations across Canada

Drugs / interventions tested

cytarabine — full drug profile →

Conditions studied

Leukemia — all drugs for Leukemia →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

NCIC Clinical Trials Group

Who can join

60 and older, any sex, with Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cytarabine may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The evolving role of FLT3 inhibitors in acute myeloid leukemia: quizartinib and beyond.
Wander SA, Levis MJ, Fathi AT. · · 2014 · cited 128× · PMID 24883179 · DOI 10.1177/2040620714532123
Targeting FLT3 to treat leukemia.
Konig H, Levis M. · · 2015 · cited 62× · PMID 25231999 · DOI 10.1517/14728222.2014.960843
FLT3 inhibitors: a story of the old and the new.
Fathi A, Levis M. · · 2011 · cited 43× · PMID 21245757 · DOI 10.1097/moh.0b013e3283439a03
FLT3 inhibition as therapy in acute myeloid leukemia: a record of trials and tribulations.
Fathi AT, Chabner BA. · · 2011 · cited 40× · PMID 21765192 · DOI 10.1634/theoncologist.2011-0084
FLT3 inhibitors in the treatment of acute myeloid leukemia: the start of an era?
Pemmaraju N, Kantarjian H, Ravandi F, Cortes J. · · 2011 · cited 38× · PMID 21319142 · DOI 10.1002/cncr.25908
Treatment of FLT3-ITD acute myeloid leukemia.
Fathi AT, Chen YB. · · 2011 · cited 34× · PMID 22432079
Exploiting cellular pathways to develop new treatment strategies for AML.
Fathi AT, Grant S, Karp JE. · · 2010 · cited 32× · PMID 20056334 · DOI 10.1016/j.ctrv.2009.12.004
The rocky road to personalized medicine in acute myeloid leukaemia.
Brinda B, Khan I, Parkin B, Konig H. · · 2018 · cited 15× · PMID 29327808 · DOI 10.1111/jcmm.13478

Verify or expand the search:

Other trials of cytarabine

Trials testing the same drug.

NCT07441967 — The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Bu · Phase 2 · not yet recruiting
NCT06744556 — HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML · Phase 2 · recruiting
NCT06744504 — Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 · Phase 3 · recruiting
NCT06451861 — Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML · Phase 2 · recruiting
NCT05712278 — A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid L · Phase 1 · terminated

Other recruiting trials for Leukemia

Currently open trials in the same condition.

NCT07405424 — Spiritual Care Intervention in Adult Patients Diagnosed With Acute Leukemia · NA · recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07148180 — A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: · Phase 1, PHASE2 · recruiting

Other NCIC Clinical Trials Group trials

Trials by the same sponsor.

NCT01916187 — Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma · Phase 1 · withdrawn
NCT01830621 — BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma · Phase 3 · completed
NCT01652144 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma · Phase 2 · completed
NCT01627054 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia · Phase 2 · completed
NCT01486368 — A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00516828 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NCIC Clinical Trials Group
Last refreshed: 4 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00516828.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing