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Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer

NCT00281125 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-03-19

No results posted yet for this study

Summary

This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).

This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.

Conditions

  • Non-Small Cell Lung Cancer and Pleural Mesothelioma

Interventions

DRUG

PTK787 and Pemetrexed with or without Cisplatin

Sponsors & Collaborators

  • Nevada Cancer Institute

    lead OTHER

Principal Investigators

  • Sunil Sharma, MD · Nevada Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-09-30
Completion
2008-08-31

Countries

  • United States

Study Locations

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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 NCT00281125 on ClinicalTrials.gov