Stay updated on L-DOS47 with Vinorelbine/Cisplatin in Lung Adenocarcinoma Clinical Trial
Sign up to get notified when there's something new on the L-DOS47 with Vinorelbine/Cisplatin in Lung Adenocarcinoma Clinical Trial page.
Latest updates to the L-DOS47 with Vinorelbine/Cisplatin in Lung Adenocarcinoma Clinical Trial page
- CheckyesterdayNo Change Detected
- Check2 days agoNo Change Detected
- Check3 days agoNo Change Detected
- Check4 days agoChange DetectedThe study has been updated to version v2.10.0 and now includes 4 locations, replacing the previous version v2.9.7.SummaryDifference0.4%
- Check5 days agoNo Change Detected
- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent change in the webpage content.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the web page.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Part I includes a brief initial dose escalation phase, followed by Part II, which includes a randomized treatment phase. Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : L-DOS47 in combination with cisplatin + vinorelbine L-DOS47 (6/9/12 µg/kg) is administered by iv on Day 1 and 8 of each 21-day treatment cycle, in combination with iv administration of standard cisplatin (80 mg/m2) on Day 2 + vinorelbine (30 mg/m2) on Day 2 and 9. Drug : L-DOS47 L-DOS47 lyophilized powder reconstituted and diluted for iv injection Drug : Cisplatin Cisplatin concentrate for solution for iv infusion Drug : Vinorelbine Vinorelbine concentrate for solution for iv infusion Other Names: vinorelbine tartrate Active Comparator : Cisplatin + vinorelbine alone Administration by iv of standard Cisplatin (80 mg/m2) on Day 1 + vinorelbine (30 mg/m2) on Day 1 and 8 of each 21-day treatment cycle. Drug : Cisplatin Cisplatin concentrate for solution for iv infusion Drug : Vinorelbine Vinorelbine concentrate for solution for iv infusion Other Names: vinorelbine tartrate Primary Outcome Measures Outcome Measure Measure Description Time Frame Time to disease progression Time from first day of study drug administration to documentation of disease progression (including death due to progression) Up to 12 weeks Secondary Outcome Measures Outcome Measure Measure Description Time Frame Objective response rate as measured using RECIST v. 1.1 Proportion of patients with a best overall response of complete response and partial response Up to 12 weeks Overall survival Time to death as defined as time from first day of study drug administration to death to to any cause Up to 12 weeks Safety and tolerability of L-DOS47 in combination with vinorelbine/cisplatin: Frequency of treatment emergence adverse events in patients Frequency of treatment emergent adverse events in patients Up to 12 weeks Keywords Provided by Helix BioPharma Corporation lung adenocarcinoma immunoconjugate tumor microenvironment alkalinization Additional Relevant MeSH Terms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Adenocarcinoma Adenocarcinoma of Lung Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Vinorelbine Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. Yes Revision: v2.9.1'SummaryDifference22%
Stay in the know with updates to L-DOS47 with Vinorelbine/Cisplatin in Lung Adenocarcinoma Clinical Trial
Enter your email address, and we'll notify you when there's something new on the L-DOS47 with Vinorelbine/Cisplatin in Lung Adenocarcinoma Clinical Trial page.