A Phase I Study of PM02734 in Subjects With Advanced Malignant Solid Tumors
| Status: | Archived |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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.
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.
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.
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