NCT01262235

A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Arbutus Biopharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.

Conditions

• Cancer
• Neuroendocrine Tumors
• NET
• Adrenocortical Carcinoma
• ACC

Interventions

Type	Name	Description
DRUG	TKM-080301	Repeat dose IV infusion.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2010-12-17
• Last updated: 2019-01-16

Locations

8 sites across 1 country: United States