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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT00884845
First received: April 16, 2009
Last updated: March 25, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT00884845     History of Changes
Other Study ID Numbers: PM2734-A-003-08
Study First Received: April 16, 2009
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaMar:
PM2734
Tumors
PharmaMar
Erlotinib
Tarceva

Additional relevant MeSH terms:
Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014