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Sponsored by: |
PharmaMar |
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Information provided by: | PharmaMar |
ClinicalTrials.gov Identifier: | NCT00404521 |
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors |
Drug: PM02734 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Single-Institution, Open-Label, Dose-Escalating, Clinical and Pharmacokinetic Study of PM02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors. |
Estimated Enrollment: | 35 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: PM02734
Administered every 3 weeks, intravenously, over 30 minutes
|
Phase I single-institution, open-label, dose-escalating, clinical and pharmacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities(DLT) and recommended dose (RD) of PM02734 administered every 3 weeks, intravenously, over 30 minutes to subjects with advanced malignant solid tumors. Secondary objectives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodynamics correlation and to evaluate the preliminary antitumor activity of PM02734. The trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values within 7 days prior to first infusion:
Exclusion Criteria:
Other relevant diseases or adverse clinical conditions:
Contact: Cinthya Coronado, MD | +34 91 846 6135 | ccoronado@pharmamar.com |
United States, Illinois | |
Cancer Research Center. University of Chicago Hospitals | Recruiting |
Chicago, Illinois, United States, 60637 | |
Principal Investigator: Mark Ratain, MD |
Principal Investigator: | Mark Ratain, MD | Cancer Research Centerr, University of Chicago Hospital |
Responsible Party: | Pharma Mar USA Inc. 64 Sidney Street. Cambridge, MA 02139-4170 USA ( Pharma Mar USA Inc. ) |
Study ID Numbers: | PM2734-A-001-05 |
Study First Received: | November 27, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00404521 |
Health Authority: | United States: Food and Drug Administration |
Tumor PM02734 PharmaMar |