We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00884845
First Posted: April 21, 2009
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaMar
  Purpose
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.

Condition Intervention Phase
Advanced Malignant Solid Tumors Drug: PM02734 and erlotinib Drug: Erlotinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 35
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name: TARCEVA

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884845


Locations
United States, New York
Montefiore Medical Center
New York, New York, United States, 10467-2490
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Intituto Universitario Dexeus
Barcelona, Spain, 08020
Sponsors and Collaborators
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)
  More Information

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT00884845     History of Changes
Other Study ID Numbers: PM2734-A-003-08
First Submitted: April 16, 2009
First Posted: April 21, 2009
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by PharmaMar:
PM2734
Tumors
PharmaMar
Erlotinib
Tarceva

Additional relevant MeSH terms:
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action