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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Malignant Solid Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Roman Pérez-Soler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center (NY - USA)

Authority:

United States: Food and Drug Administration

Study ID:

PM2437-A-003-08

NCT ID:

NCT00884845

Start Date:

January 2009

Completion Date:

June 2011

Related Keywords:

  • Advanced Malignant Solid Tumors
  • PM2734
  • Tumors
  • PharmaMar
  • Erlotinib
  • Tarceva
  • Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490