![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Calando Pharmaceuticals |
|---|---|
| Information provided by: | Calando Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00333502 |
Purpose
RATIONALE: IT-101 is a conjugate of camptothecin (CPT) and a linear, cyclodextrin-based polymer. IT-101 is designed to increase the exposure of tumor cells to the chemotherapeutic drug while minimizing the toxic side effects.
PURPOSE: This phase I trial will:
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Ovarian Cancer Non Small Cell Lung Cancer Pancreatic Cancer Solid Tumor |
Drug: IT-101 |
Phase I |
Camptothecin (CPT), an alkaloid extract from plants such as Camptotheca acuminata, has a broad range of anticancer activity in animal models. Its activity is thought to be due to the inhibition of DNA topoisomerase I. CPT inhibits resealing of DNA that has been nicked in the course of DNA synthesis. This in turn halts nucleic acid synthesis and ultimately leads to cell death.
IT-101 is a conjugate of camptothecin (CPT) and a linear, cyclodextrin-based polymer (CDP). The components of CDP are beta-cyclodextrin and polyethylene-glycol (PEG), both of which are used in a variety of drug formulations. Camptothecin is covalently attached to CDP through a glycine linker which preserves CPT in its active form and increases its water solubility by greater than 1000 fold. Once injected into the blood circulation, camptothecin is slowly released from the polymer conjugate through hydrolysis of an ester linkage. In addition to improving solubility and stability, polymer-drug conjugation can enhance the accumulation of the drug in tumors by taking advantage of the enhanced permeability and retention (EPR) effect, a mechanism through which macromolecules extravasate out of the abnormally leaky vasculature of tumors.
This will be an open-label, dose-escalation, study of IT-101 administered in patients with solid tumor malignancies. Patients who satisfy the inclusion/exclusion criteria will receive injections of IT-101 every other week. Patients will be monitored for a response using RECIST criteria every 2 months.
Eligibility
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| Study Chair: | Yuen Yen, MD, Ph.D. | City of Hope National Medical Center |
More Information