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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ONIVYDE

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Clinical Trials for Onivyde

Trial ID Title Status Sponsor Phase Summary
NCT02231723 A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer Recruiting Boston Biomedical, Inc Phase 1 This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.
NCT02631733 Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Suspended National Cancer Institute (NCI) Phase 1 This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors that have spread to other parts of the body (metastatic) or cannot be removed by surgery. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02785068 Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer Recruiting Merrimack Pharmaceuticals Phase 1/Phase 2 A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in RAS/RAF wild-type Metastatic Colorectal Cancer.
NCT03088813 Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer Not yet recruiting Ipsen Phase 3 This is an open-label phase 3 comparative study to assess the safety, tolerability, and efficacy of irinotecan liposome injection compared to topotecan (IV) in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy. The study will be conducted in two parts: 1a. dose determination of irinotecan liposome injection 1b. preliminary safety and efficacy 2. a randomized, efficacy study of irinotecan liposome injection versus topotecan
NCT03119064 BrUOG 329 GBM Onyvide With TMZ Recruiting Merrimack Pharmaceuticals Phase 1/Phase 2 New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.
NCT03119064 BrUOG 329 GBM Onyvide With TMZ Recruiting Rhode Island Hospital Phase 1/Phase 2 New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Onivyde

Condition Name

Condition Name for Onivyde
Intervention Trials
Metastatic Pancreatic Adenocarcinoma 2
Pancreatic Adenocarcinoma 2
Stage IIIB Non-Small Cell Lung Cancer 1
Stage IV Non-Small Cell Lung Cancer 1
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Condition MeSH

Condition MeSH for Onivyde
Intervention Trials
Pancreatic Neoplasms 4
Adenocarcinoma 4
Carcinoma 3
Small Cell Lung Carcinoma 2
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Clinical Trial Locations for Onivyde

Trials by Country

Trials by Country for Onivyde
Location Trials
United States 27
Taiwan 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Onivyde
Location Trials
Arizona 4
Washington 3
Tennessee 2
Indiana 2
New York 2
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Clinical Trial Progress for Onivyde

Clinical Trial Phase

Clinical Trial Phase for Onivyde
Clinical Trial Phase Trials
Phase 3 1
Phase 2 6
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Onivyde
Clinical Trial Phase Trials
Not yet recruiting 7
Recruiting 6
Suspended 1
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Clinical Trial Sponsors for Onivyde

Sponsor Name

Sponsor Name for Onivyde
Sponsor Trials
National Cancer Institute (NCI) 3
Ipsen 2
Merrimack Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Onivyde
Sponsor Trials
Other 17
Industry 8
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Citi
UBS
US Department of Justice
Chinese Patent Office
McKesson
Deloitte
US Army
Baxter

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