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LY2275796 in Advanced Cancer

NCT00903708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-07-30

No results posted yet for this study

Summary

Primary Objective:

* To determine a recommended Phase 2 dose of LY2275796 that may be safely administered to patients with advanced cancer, with prospects for therapeutic biologic effects. This will require simultaneous:
* monitoring of toxicities \& determination of maximal tolerated dose (MTD)
* detecting eIF-4E target inhibition in tumor
* pharmacokinetic measurements

Secondary Objectives:

* To estimate pharmacokinetic parameters of LY2275796 and explore pharmacokinetic/pharmacodynamic relationships
* To document any antitumor activity observed with LY2275796

Conditions

Interventions

DRUG

LY2275796

100 mg administered by vein as a loading dose daily over 3 days, and then as a maintenance dose weekly thereafter.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Hong, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903708 on ClinicalTrials.gov