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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00884845
Other study ID # PM2734-A-003-08
Secondary ID
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


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
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