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

March 25, 2014 updated by: PharmaMar

Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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, determine the preliminary pharmacokinetics (PK) of the combination, evaluate the preliminary PK/pharmacodynamic correlation, evaluate the preliminary antitumor activity, perform a preliminary pharmacogenomic (PGx) study to explore molecular predictors of response to ErbB receptor antagonists and PM02734 in patient with advanced malignant solid tumors.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08020
        • Intituto Universitario Dexeus
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
  • United States
    • New York
      • New York, New York, United States, 10467-2490
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntary written informed consent form.
  • Histologically or cytologically confirmed advanced malignant solid tumors.
  • Measurable or non-measurable disease following (RECIST)
  • Age ≥ 18 years.
  • Life expectancy ≥ 3 months.
  • Performance status ECOG ≤ 2.
  • Recovery from any drug-related adverse events (AEs) derived from previous treatments.
  • Appropriate bone marrow, liver and renal function.
  • Left ventricular ejection fraction (LVEF) within normal limits for the institution.
  • Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.

Exclusion Criteria:

  • Prior therapy with PM02734.
  • Pregnant or lactating women.
  • Less than four weeks from radiation therapy.
  • Evidence of progressive central nervous system (CNS) metastases. or any symptomatic brain or leptomeningeal metastases.
  • Other relevant diseases or adverse clinical conditions.
  • Any other major illness that, in the Investigator's judgment.
  • Limitation of the patient's ability to comply with the treatment or to follow-up at a participating protocol.
  • Ingestion of potent cytochrome CYP3A4 inhibitors.
  • Treatment with any investigational product in the 30-day period prior to the first infusion.
  • Known hypersensitivity to any component of PM02734 or erlotinib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib
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
Other Names:
  • Brand name: TARCEVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaMar

Investigators

  • Principal Investigator: Roman Pérez-Soler, M.D., Montefiore Medical Center (NY - USA)
  • Principal Investigator: Rafael Rosell, M.D., Hospital Universitario Germans Trias i Pujol (Badalona - Spain)
  • Principal Investigator: Mauricio Cuello, M.D., Instituto Universitario Dexeus (Barcelona - Spain)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (ESTIMATE)

April 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM2734-A-003-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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