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Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

NCT00884845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-03-26

No results posted yet for this study

Summary

Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

DRUG

PM02734 and erlotinib

PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion

DRUG

Erlotinib

Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • Roman Pérez-Soler, M.D. · Montefiore Medical Center (NY - USA)

  • Rafael Rosell, M.D. · Hospital Universitario Germans Trias i Pujol (Badalona - Spain)

  • Mauricio Cuello, M.D. · Instituto Universitario Dexeus (Barcelona - Spain)

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
2009-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • Spain

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 NCT00884845 on ClinicalTrials.gov