Status:
COMPLETED
Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
Lead Sponsor:
PharmaMar
Conditions:
Advanced Malignant Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 d...
Detailed 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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00884845
Start Date
January 1 2009
End Date
June 1 2011
Last Update
March 26 2014
Active Locations (3)
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1
Montefiore Medical Center
New York, New York, United States, 10467-2490
2
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Intituto Universitario Dexeus
Barcelona, Barcelona, Spain, 08020