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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR LEVOLEUCOVORIN

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Clinical Trials for Levoleucovorin

Trial ID Title Status Sponsor Phase Summary
NCT01290783 Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC Unknown status Alchemia Oncology Phase 3 Trial design: - Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. - Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. - Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). - Dosing regimen: - Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2). - Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. - 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. - Repeat every 2 weeks for 8 months. - Patient accrual over approximately 12-14 months. - Monitoring to 18 months post-randomization. - 390 patients. - Progression Free Survival (PFS) primary endpoint. - Safety analysis on the initial 20 patients.
NCT01611857 Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach Completed Daiichi Sankyo Inc. Phase 1/Phase 2 This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
NCT01611857 Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach Completed SCRI Development Innovations, LLC Phase 1/Phase 2 This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
NCT01681472 PK/PD Investigation of Modufolin® in Plasma, Tumor and Adjacent Mucosa in Patients With Colon Cancer Completed Isofol Medical AB Phase 1/Phase 2 The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®) respectively (60 and 200 mg/m2).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Levoleucovorin

Condition Name

Condition Name for Levoleucovorin
Intervention Trials
Colorectal Cancer 2
Metastatic Colorectal Cancer 2
Stage IIB Pancreatic Cancer 1
Malignant Solid Tumour 1
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Condition MeSH

Condition MeSH for Levoleucovorin
Intervention Trials
Colorectal Neoplasms 4
Neoplasms 2
Adenocarcinoma 2
Mucositis 2
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Clinical Trial Locations for Levoleucovorin

Trials by Country

Trials by Country for Levoleucovorin
Location Trials
United States 9
Australia 2
Belgium 2
China 1
Sweden 1
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Trials by US State

Trials by US State for Levoleucovorin
Location Trials
Tennessee 2
Connecticut 2
Washington 1
Texas 1
South Carolina 1
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Clinical Trial Progress for Levoleucovorin

Clinical Trial Phase

Clinical Trial Phase for Levoleucovorin
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Levoleucovorin
Clinical Trial Phase Trials
Withdrawn 3
Recruiting 3
Completed 2
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Clinical Trial Sponsors for Levoleucovorin

Sponsor Name

Sponsor Name for Levoleucovorin
Sponsor Trials
Spectrum Pharmaceuticals, Inc 2
Isofol Medical AB 1
NuCana plc 1
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Sponsor Type

Sponsor Type for Levoleucovorin
Sponsor Trials
Other 5
Industry 5
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Merck
Daiichi Sankyo
Accenture
Farmers Insurance
Fish and Richardson
Cipla
Dow

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