NCT02171221

Phase I Study of Oral DFP-11207 in Solid Tumors

A Phase I Study of Once-Daily Oral DFP-11207 in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Delta-Fly Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open label, single arm, sequential dose escalation and expansion study of oral DFP-11207 in patients with advanced solid tumors.

Detailed description

The Phase I dose escalation portion of the study has been completed. The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been determined. The study will now evaluate the effect of food on the pharmacokinetics of DFP-11207. The food effect study is a two-step, two-way crossover design to evaluate the pharmacokinetics and bioavailability of oral DFP-11207 capsules. During Cycle 1, oral DFP-11207 capsules are to be taken daily (as a single dose or twice-daily \[approximately 12 hours apart\]) under fed/fasted conditions. After Cycle 1, the food effect study will be completed and patients will continue to take oral DFP-11207 capsules twice-daily (approximately 12 hours apart) for 28 days of a 28-day treatment cycle.

Conditions

• Solid Tumors
• Cancer

Interventions

Type	Name	Description
DRUG	Oral DFP-11207

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-09-13
• Completion: 2018-09-13
• First posted: 2014-06-24
• Last updated: 2019-01-29

Locations

1 site across 1 country: United States