Viewing Study NCT01800630



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Last Modification Date: 2024-10-26 @ 11:03 AM
Study NCT ID: NCT01800630
Status: COMPLETED
Last Update Posted: 2019-07-08
First Post: 2013-02-23

Brief Title: Phase1 Study of Gemcitabine HCl Oral FormulationD07001-F4 in Patients With Advanced Solid Malignancies and Malignant Lymphomas
Sponsor: InnoPharmax Inc
Organization: InnoPharmax Inc

Study Overview

Official Title: An Open Label Phase 1 Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral FormulationD07001-F4 in Patients With Advanced Solid Malignancies and Malignant Lymphomas
Status: COMPLETED
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Open-label Phase 1 sequential dose-escalation study of 10 increasing doses 3 to 6 patients eachto determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation D07001-F4 Patients will be assigned to receive oral D07001-F4 on Days 1 3 5 8 10 and 12 of 4 21-day cycles each to further characterize safety and tolerability
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None