NCT01800630

Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: InnoPharmax Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to 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.

Conditions

• Advanced Solid Malignancies
• Malignant Lymphomas

Interventions

Type	Name	Description
DRUG	Gemcitabine HCl Oral Formulation

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-11-01
• Completion: 2016-03-01
• First posted: 2013-02-28
• Last updated: 2019-07-08

Locations

3 sites across 1 country: Taiwan