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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Malignant Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PM02734 and erlotinib

Intervention Type DRUG

PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion

Erlotinib

Intervention Type DRUG

Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Interventions

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PM02734 and erlotinib

PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion

Intervention Type DRUG

Erlotinib

Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Intervention Type DRUG

Other Intervention Names

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Brand name: TARCEVA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No