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| Sponsor: | Cerulean Pharma Inc. |
|---|---|
| Information provided by (Responsible Party): | Cerulean Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00333502 |
Purpose
CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.
OBJECTIVES:
• Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Solid Tumor |
Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors |
| Enrollment: | 62 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Virginia G. Piper Cancer Center | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| United States, New Mexico | |
| San Juan Oncology Associates | |
| Farmington, New Mexico, United States, 87401 | |
| Principal Investigator: | Yun Yen, M.D., Ph.D. | City of Hope National Medical Center |
| Principal Investigator: | Glenn Weiss, M.D. | Virginia G. Piper Cancer Center |
| Principal Investigator: | Jeffrey D. Neidhart, M.D. | San Juan Oncology Associates |
More Information
| Responsible Party: | Cerulean Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00333502 History of Changes |
| Other Study ID Numbers: | CRLX-001, City of Hope IRB number 05127 |
| Study First Received: | June 1, 2006 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Lung Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, Breast Cancer, Colon Cancer, Endometrial Cancer, |
Kidney (Renal Cell) Cancer, Melanoma, Prostate Cancer, Skin Cancer, Thyroid Cancer, Solid Malignancies |
|
Neoplasms Camptothecin Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |