|
|
|
|
|
Sponsored by: |
PharmaMar |
Information provided by: | PharmaMar |
ClinicalTrials.gov Identifier: | NCT00404521 |
Phase I single-institution, open-label, dose-escalating, clinical and pahamacokinetic study. The purpose is to determine the safety, tolerability and to identify the dose limiting toxicities and recommendaded dose (RD) of PM02734 administared every 3 weeks, intravenously, over 3 minutes to subjects with advanced malignant solid tumors. Secondary objetives are to determine preliminary Pharmacokinetics of PM02734, to explore the relationships between pharmacokinetics and pharmacodynamics. To evaluate the preliminary pharmacokinetics/pharmacodinamics 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.
Condition | Intervention | Phase |
Solid Tumors |
Drug: PM02734 |
Phase I |
MedlinePlus related topics: | Cancer Health Facilities |
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 PM 02734 Administered Every 3 Weeks, Intravenously, Over 30 Minutes, to Subjects With Advanced Malignant Solid Tumors. |
Estimated Enrollment: | 35 |
Study Start Date: | August 2005 |
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: Begoña De las Heras, MD | 34 91 823 46 14 | bheras@pharmamar.com |
United States, Illinois | |||||
Cancer Research Center. University of Chicago Hospitals | Recruiting | ||||
Chicago, Illinois, United States, 60637 | |||||
Principal Investigator: Mark Ratain, MD |
PharmaMar |
Principal Investigator: | Mark Ratain, MD | Cancer Research Centerr, University of Chicago Hospital |
Sponsor's website 
  |
Study ID Numbers: | PM2734-A-001-05 |
First Received: | November 27, 2006 |
Last Updated: | November 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00404521 |
Health Authority: | United States: Food and Drug Administration |
|