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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00884845 |
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Date of registration:
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16/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
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Scientific title:
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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 |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00884845 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Spain
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United States
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Contacts
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Name:
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Rafael Rosell, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario Germans Trias i Pujol (Badalona - Spain) |
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Name:
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Mauricio Cuello, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Universitario Dexeus (Barcelona - Spain) |
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Name:
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Roman Pérez-Soler, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montefiore Medical Center (NY - USA) |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Malignant Solid Tumors
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Intervention(s)
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Drug: Erlotinib
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Drug: PM02734 and erlotinib
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Primary Outcome(s)
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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
[Time Frame: 2 years]
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Secondary Outcome(s)
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To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
[Time Frame: 2 years]
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Secondary ID(s)
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PM2734-A-003-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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