NCT02890511

A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer

A Study of DHP107, a Novel Oral Paclitaxel Formulation, to Determine Maximum Tolerated Dose and Recommended Dose for Phase II Trial in Patients With Advanced Solid Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Daehwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer

Detailed description

1. Primary objective To determine the maximum tolerated dose and the recommended dose for phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on advanced solid cancer patients 2. Secondary objectives * To identify the dose limiting toxicity and the safety (toxicity) of DHP107 * To evaluate the efficacy (tumor response rate) of DHP107 * To assess pharmacokinetic (PK) characteristics of DHP107

Conditions

• Solid Tumor
• Stage IV Gastric Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2016-09-07
• Last updated: 2017-02-13

Locations

1 site across 1 country: South Korea