NCT02706899

Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).

Detailed description

In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	vadastuximab talirine	Intravenous (IV) push every 4 weeks
DRUG	Azacitidine	75 mg/m\^2 given intravenously or subcutaneously for 7 days every 4 weeks
DRUG	Placebo (for 33A)	Placebo supplied in single-use vials matching 33A, IV push every 4 weeks

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-06
• Completion: 2017-11-06
• First posted: 2016-03-11
• Last updated: 2019-02-12
• Results posted: 2018-12-21

Locations

34 sites across 1 country: United States