NCT01781429

Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: BioMed Valley Discoveries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The study also seeks to demonstrate target modulation and early signs of clinical response in select patient populations.

Detailed description

The study is being performed to assess the safety and tolerability of BVD-523 In Part 1 of the study, an accelerated dose escalation plan will be used to establish dose limiting toxicities, maximum tolerated dose, and the recommended Phase 2 dose. In Part 2 of the study, additional patients with particular tumor types and/or cancers harboring specific genetic mutations will be recruited for treatment at the Recommended Phase 2 Dose. Patients may also be assessed pharmacodynamic measures in healthy or malignant tissues, using biomarker assays for phosphorylation, cytotoxic or cytostatic measures.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BVD-523	Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-02-01
• Completion: 2018-09-01
• First posted: 2013-02-01
• Last updated: 2020-03-20
• Results posted: 2020-03-20

Locations

9 sites across 1 country: United States