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A Study of IMC-A12 in Advanced Solid Tumors

NCT01007032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-02-27

Study results available
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Summary

In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing a best overall response of complete response, partial response, or stable disease will continue to receive cixutumumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met. Participants will be enrolled at one study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan. Approximately 20-30 participants are anticipated.

Conditions

Interventions

BIOLOGICAL

Cixutumumab

Cixutumumab intravenously

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-12-31
Completion
2015-04-30

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

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 NCT01007032 on ClinicalTrials.gov