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

April 16, 2009
March 25, 2014
January 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00884845 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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 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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Malignant Solid Tumors
  • 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
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
Interventions:
  • Drug: PM02734 and erlotinib
  • Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT00884845
PM2734-A-003-08
No
PharmaMar
PharmaMar
Not Provided
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)
PharmaMar
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP