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Last Updated: May 14, 2021

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CLINICAL TRIALS PROFILE FOR CRLX101

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Clinical Trials for CRLX101

Trial ID Title Status Sponsor Phase Summary
NCT00333502 Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors Completed Cerulean Pharma Inc. Phase 1/Phase 2 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.
NCT01380769 A Phase 2 Study of CRLX101 in Patients With Advanced Non-Small Cell Lung Cancer Completed Cerulean Pharma Inc. Phase 2 The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).
NCT01612546 Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery Completed National Cancer Institute (NCI) N/A This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has progressed through at least one prior regimen of chemotherapy and cannot be removed by surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor cells and is hypothesized to interrupt the growth of tumor cells.
NCT01612546 Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery Completed City of Hope Medical Center N/A This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has progressed through at least one prior regimen of chemotherapy and cannot be removed by surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor cells and is hypothesized to interrupt the growth of tumor cells.
NCT01625936 CRLX101 Plus Bevacizumab in Advanced RCC Active, not recruiting Abramson Cancer Center of the University of Pennsylvania Phase 1 This is a Phase 1b, dose escalation study of the investigational agent, CRLX101, given in combination with Bevacizumab in patients with advanced renal cell carcinoma. The purpose of this study is to determine the initial safety and effectiveness of this agent in combination with Bevacizumab. The investigators are also trying to determine the best dose level of CRLX101 to give in combination with bevacizumab. About 22 subjects will be enrolled in this study at the University of Pennsylvania.
NCT01652079 CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer Unknown status Massachusetts General Hospital Phase 2 This research study is a Phase II clinical trial. In addition to studying safety, Phase II clinical trials test if the investigational drug is effective and whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved CRLX101 for your type of cancer. Camptothecin is a chemical extracted from plants that is the basis for the standard FDA-approved chemotherapy drugs irinotecan and topotecan. Camptothecin works by interfering with the way cells divide and multiply. The investigational drug CRLX101 is a formulation of camptothecin and a large molecule (nanoparticle)that appears to allow more of the camptothecin to get into tumors and stay in tumors. The persistence of the CRLX101 in the tumor may increase the probability that the tumor cells will be damaged. CRLX101 has been well tolerated in the laboratory and in participants with different kinds of cancer. Bevacizumab (Avastin) is a VEGF inhibitor which has activity in many kinds of cancer. Bevacizumab has been successfully combined with many chemotherapy partners. It has been hypothesized that the combination of bevacizumab with CRLX101 might have unique clinical activity in combination in the treatment of this disease due to the simultaneous inhibition of distinct steps along the HIF → (CAIX) → VEGF → VEGFR2 pathway. Specifically, it is hypothesized that CRLX101-mediated inhibition of HIF-1α carries with it the potential to interrupt hypoxia and HIF-1α-associated resistance to VEGFR inhibitors. It is hoped that this combination will work to treat your type of cancer.
NCT01803269 Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer Terminated National Cancer Institute (NCI) Phase 2 This randomized phase II trial studies how well giving topotecan hydrochloride or cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether topotecan hydrochloride is more effective than cyclodextrin-based polymer-camptothecin CRLX101 in treating patients with lung cancer.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for CRLX101

Condition Name

Condition Name for
Intervention Trials
Solid Tumors 2
Ovarian Cancer 2
Stage IIIB Esophageal Cancer 1
Non-Small Cell Lung Cancer 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Lung Neoplasms 3
Carcinoma 3
Carcinoma, Renal Cell 2
Carcinoma, Non-Small-Cell Lung 2
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Clinical Trial Locations for CRLX101

Trials by Country

Trials by Country for
Location Trials
United States 46
Russian Federation 3
Korea, Republic of 1
Ukraine 1
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Trials by US State

Trials by US State for
Location Trials
Pennsylvania 3
Maryland 3
California 3
Indiana 2
Colorado 2
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Clinical Trial Progress for CRLX101

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 5
Phase 1/Phase 2 4
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 4
Completed 3
Active, not recruiting 2
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Clinical Trial Sponsors for CRLX101

Sponsor Name

Sponsor Name for
Sponsor Trials
Cerulean Pharma Inc. 6
National Cancer Institute (NCI) 4
UNC Lineberger Comprehensive Cancer Center 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
Other 5
NIH 4
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