Clinical trial NCT00884845: Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumors
Keywords: PM2734
Tumors
PharmaMar
Erlotinib
Tarceva
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
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
timeFrame: 2 years
Secondary outcomes:
measure: To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Intituto Universitario Dexeus
Study officials:
affiliation: Montefiore Medical Center (NY - USA)
name: Roman Pérez-Soler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Germans Trias i Pujol (Badalona - Spain)
name: Rafael Rosell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Universitario Dexeus (Barcelona - Spain)
name: Mauricio Cuello, M.D.
role: PRINCIPAL_INVESTIGATOR
References: