Drugs / GATAPARSEN

Trials 4

20082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT00415155 Aug 2008 → Jan 2011 hepatocellular carcinoma Eli Lilly and Company Withdrawn No outcome recorded
Phase 23 trials · 1 missed
Phase 2 NCT01107444 May 2010 → Dec 2011 non-small cell lung carcinoma Eli Lilly and Company Completed Missed primary
Phase 2 NCT00642018 Mar 2008 → Aug 2011 prostate cancer Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT00620321 Mar 2008 → Jan 2010 acute myeloid leukemia Eli Lilly and Company Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2009-06-01 Ionis Pharmaceuticals Results Isis Highlights New Clinical Data on Anti-Cancer Antisense Drugs Featured at ASCO ionis.com ↗
In addition, new results from a Phase 1 trial evaluating LY2181308, an antisense drug discovered by Isis and licensed to Eli Lilly and Company, in patients with cancer were also presented.
2008-06-02 Ionis Pharmaceuticals Results Isis' Partners Present Clinical Data on Antisense Drugs at the American Society of Clinical Oncology ionis.com ↗
Lilly presented first-in-human data from LY2181308 that showed the drug distributed to tumor cells with evidence of reduced survivin protein levels in tumor cells, LY2181308's target and one of the most commonly elevated proteins in cancer.
2003-11-20 Ionis Pharmaceuticals Results Antisense Drug Targeting Survivin Inhibits Growth Of Tumors In Animal Models ionis.com ↗
Antitumor activity was associated with significant reduction of survivin expression in tumors, evidence that the drug was working through an antisense mechanism.

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as GATAPARSEN ChEMBL registry synonym — accepted as the source's own label CHEMBL2219774 ↗
Known as GATAPARSEN SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL2219774 ↗
Known as LY-2181308 HEPTADECASODIUM SALT ChEMBL registry synonym — accepted as the source's own label CHEMBL2219774 ↗
Known as LY2181308 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00415155 ↗
3

NCT01107444 ↗

NCT00620321 ↗

NCT00642018 ↗

Known as LY2181308 sodium “LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days.” NCT00642018 ↗
Known as sodium LY2181308 “The antisense oligonucleotide sodium LY2181308 (LY2181308) inhibits survivin expression and may cause cell cycle arrest and restore apoptosis in AML.” PMID 23397500 ↗ Feb 2013
Action Inhibit “inhibits survivin expression” PMID 23397500 ↗ Feb 2013
Modality Antisense oligonucleotide “Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308” PMID 23397500 ↗ Feb 2013
Route Intravenous “250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle.” NCT00415155 ↗