TRIAL DETAIL

Phase 1 Study of Continuous OSI-906 Dosing

Drug:	Linsitinib (OSI-906)
Trial Name:	Phase 1 Study of Continuous OSI-906 Dosing
NCT#:	NCT00514007
Conditions:	Solid Tumors
Status:	Ongoing, but not recruiting
Phase:	1	Start Date 12/01/2006	Age of Trial (yrs) 18.5
Treatment Phase:	Gleevec-resistant
Drug Category:	IGF1R inhibitor
Strategy:	Block related tumor signal paths
Trial Type:	GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:	OSI-906-101
Sponsor:	OSI Pharmaceuticals
Patient Contact:	OSIP Medical Information 800.572.1932, x7821 medical-information@osip.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:	Oral
Trial Notes:	Detailed Description: Multicenter, open-label, phase 1, cohort dose escalation. The study will open with the QD schedule, with initiation of the BID schedule occurring after observation of clinically significant related toxicity * grade 2 in the QD schedule. Dosing will be initiated on Day 1 with daily dosing (either QD or BID) continuing for 21 days. Patients may continue to receive OSI-906 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Trial Links

Trial Results

ASCO 2010 - Phase I dose-escalation study of continuous oral dosing of OSI-906, a dual tyrosine kinase inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor (IR), in patients with advanced solid tumors.

2015 - A Phase I Study of Continuous Oral Dosing of OSI-906, a Dual Inhibitor of Insulin-Like Growth Factor-1 and Insulin Receptors, in Patients with Advanced Solid Tumors

Drug Information

Dicovery of OSI-906 a selective and orally efficacious dual inhibitor of the IGF-1 receptor and insulin receptor

OSI-906 from the OSI website

LRG article- Oct., 2012 - New developments seen in Pediatric-like GIST

LRG article - Aug., 2012 - New gene panel takes mutation testing to a new level. This new 23 gene test is especially good for wild-type GIST as it tests for mutations in the various SDH genes as well as BRAF, HRAS and KRAS.

LRG article (as reported by Becky Bensenhaver) - Aug., 2012 - NIH clinic shares information on 3 trials

Wildtype GIST & SDH: what to know, by Jennifer Wright. LRG Newsletter article, April, 2011.

Trial Sites

Name	Address	City	State	Zip	Country
Vanderbilt-Ingram Cancer Center	2220 Pierce Ave.	Nashville	TN	37232	USA
Beatson West of Scotland Cancer Centre		Glasgow		G12 0YN	UK