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

Advanced Malignant Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884845
• Other study ID #: PM2734-A-003-08
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2009
• Last updated: March 25, 2014
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2014
• Source: PharmaMar
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors
• Neoplasms

Intervention

Drug:
• PM02734 and erlotinib
PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
• Erlotinib
Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Locations

Country	Name	City	State
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Intituto Universitario Dexeus	Barcelona
United States	Montefiore Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
PharmaMar

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	Yes
Secondary	To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.		2 years	No