6 completed, 6 terminated, 1 withdrawn. 11 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 5, Terminated 5, Withdrawn 1 |
| Phase 1 | 6 | Terminated 4, Completed 2 |
Follow IT-101: new trials by email Literature Review of IT-101 trials Research Report on IT-101
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment enzalutamide, CRLX101 - Metastatic Castration Resistant Prostate Cancer, Prostate Neoplasms | Phase 2 | Terminated | National Cancer Institute (NCI) | 4 | 2019-03-26 | 2022-07-12 |
| Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer EP0057, olaparib, CT scan - Urothelial Carcinoma, Urothelial Cancer | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 45 | 2016-05-09 | 2026-08-13 |
| Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors CRLX101, Bevacizumab, mFOLFOX6 - Solid Tumors | Phase 1 | Terminated | NewLink Genetics Corporation | 41 | 2015-10-01 | 2020-05-28 |
| A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer CRLX101, Paclitaxel - Ovarian Cancer | Phase 1 / Phase 2 | Terminated | NewLink Genetics Corporation | 30 | 2015-07-01 | 2026-06-18 |
| CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC) CRLX101, Bevacizumab, Standard of Care (Investigator Choice) - Metastatic Renal Cell Carcinoma | Phase 2 | Completed | NewLink Genetics Corporation | 115 | 2014-07-01 | 2020-05-28 |
| Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer CRLX101, Capecitabine, Radiotherapy - Rectal Cancer | Phase 1 / Phase 2 | Terminated | UNC Lineberger Comprehensive Cancer Center | 32 | 2013-12-01 | 2020-11-03 |
| Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer topotecan hydrochloride, cyclodextrin-based polymer-camptothecin CRLX101 - Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer | Phase 2 | Terminated | University of Chicago | 29 | 2013-01-16 | 2020-06-26 |
| Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery cyclodextrin-based polymer-camptothecin CRLX101, Laboratory biomarker analysis, Pharmacological studies - Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction | Phase 2 | Completed | City of Hope Medical Center | 10 | 2012-11-01 | 2018-02-01 |
| CRLX101 Plus Bevacizumab in Advanced RCC CRLX101 (Cerulean), Bevacizumab - Renal Cell Carcinoma | Phase 1 | Completed | Abramson Cancer Center at Penn Medicine | 22 | 2012-06-01 | 2018-08-29 |
| CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer CRLX101 - Ovarian Cancer, Fallopian Tube Cancer | Phase 2 | Completed | Massachusetts General Hospital | 63 | 2012-04-01 | 2018-07-02 |
| A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer CRLX101, Best Supportive Care - Non-Small Cell Lung Cancer | Phase 2 | Completed | NewLink Genetics Corporation | 157 | 2011-06-01 | 2020-05-28 |
| Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients. IT-101 (12mg/m2/dose), IT-101 (15mg/m2/dose), 5% Dextrose (Placebo) - Cancer, Ovarian Cancer | Phase 2 | Withdrawn | NewLink Genetics Corporation | 2008-09-01 | 2020-06-12 | |
| Study of CRLX101 (NLG207) in the Treatment of Advanced Solid Tumors Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer - Cancer, Solid Tumor | Phase 1 / Phase 2 | Completed | NewLink Genetics Corporation | 62 | 2006-05-01 | 2020-05-28 |
Ovarian Neoplasms (4) · Prostatic Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (2) · Carcinoma, Renal Cell (2) · Lung Neoplasms (2) · Neoplasms (2) · Small Cell Lung Carcinoma (2) · Adenocarcinoma Of Esophagus (1) · Breast Neoplasms (1) · Carcinoma, Transitional Cell (1) · Colonic Neoplasms (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1) · Esophageal Squamous Cell Carcinoma (1)
NewLink Genetics Corporation (6) · National Cancer Institute (NCI) (2) · Abramson Cancer Center at Penn Medicine (1) · City of Hope Medical Center (1) · Massachusetts General Hospital (1) · UNC Lineberger Comprehensive Cancer Center (1) · University of Chicago (1)
United States (12) · Russia (1) · South Korea (1) · Ukraine (1)
NewLink Genetics (2) · Andrew Wang, MD (1) · Anish Thomas, M.D. (1) · Franco Muggia, MD (1) · Glenn Weiss, M.D. (1) · Jeffrey D. Neidhart, M.D. (1) · Jonathan S Berek, MD, MMS (1) · Joseph Chao (1) · Naomi M Haas, MD (1) · NewLink Ge (1) · Ravi A Madan, M.D. (1) · Ravi Salgia (1) · Richard Penson, MD, MRCP (1) · Yun Yen, M.D., Ph.D. (1)
PMID 32897402, PMID 27784746, PMID 28950297, PMID 30858085, PMID 33390325, PMID 33632874, PMID 35640474, PMID 42820295