NCT01631279

A Dose Escalation Trial of PR610 Treating Patients With Solid Tumors

A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects With Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Proacta, Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the Maximum Tolerated Dose and the Dose-Limiting Toxicity of the drug to further evaluate safety and antitumor activity.

Detailed description

Following informed consent, subjects undergo baseline evaluation and disease assessment. PR610 is administered intravenously weekly. In the absence of progressive disease or unacceptable toxicity, subjects may continue to receive PR610. Intra-subject dose escalation (to no higher than the highest safe level) is allowed in subjects who are not experiencing dose limiting toxicity. Disease assessment will be repeated at week 6 and then every 8 weeks thereafter. Pharmacokinetic (PK) assessment (PR610 and PR610E) will be performed for all subjects. After determination of the MTD and the determination of the phase II dose, additional subjects with NSCLC that is genetically resistant to reversible EGFR inhibitors will be accrued into an expansion cohort.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	PR610	Dose escalation of PR610 to determine maximum tolerated dose for weekly administration

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-03-01
• Completion: 2015-08-01
• First posted: 2012-06-29
• Last updated: 2014-06-16

Locations

6 sites across 2 countries: United States, New Zealand