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, 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.

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.