NCT01407380

Study of PWT33597 Mesylate in Subjects With Advanced Malignancies

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered PWT33597 Mesylate in Subjects With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pathway Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered PWT33597 mesylate in subjects with advanced malignancies.

Detailed description

This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases. The Dose Escalation Phase (up to 36 patients) will determine the MTD of PWT33597 mesylate and evaluate its safety and tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation Phase (up to 36 patients) will be a cohort expansion at or below the MTD of PWT33597 mesylate. Subjects will be treated with once-daily oral doses of PWT33597 in consecutive, 28-day cycles. Subjects will be evaluated regularly for safety. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug. Subjects who tolerate the drug and who do not experience progressive disease may continue to receive PWT33597 mesylate at the discretion of the principal investigator for up to 24 cycles

Conditions

• Malignancies

Interventions

Type	Name	Description
DRUG	PWT33597 mesylate	PWT33597 taken orally daily for 28 consecutive days in 28 day cycle

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-08-02
• Last updated: 2012-10-25

Locations

4 sites across 1 country: United States