Cancer Clinical Trial - Phase I Study of Oral DFP-11207 in Solid Tumors

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02171221
Study type	Interventional
Source	Delta-Fly Pharma, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	June 2014
Completion date	September 13, 2018

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