Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

NCT00611468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2011-08-22

Study results available
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Summary

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Conditions

  • Metastatic Solid Tumor

Interventions

DRUG

Topotecan

All subjects receive treatment with intravenous topotecan and oral erlotinib.

DRUG

Erlotinib

All subjects receive treatment with intravenous topotecan and oral erlotinib.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Genentech, Inc.

    collaborator INDUSTRY
  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Lee S. Schwartzberg, MD, FACP · Accelerared Community Oncology Research Network, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT00611468 on ClinicalTrials.gov