NCT01957644

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML

An Open Label Phase I Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Patients With Previously Untreated High-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Not Candidates for Haematopoetic Stem Cell Transplant

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic

Interventions

Type	Name	Description
DRUG	Azacitidine
DRUG	Volasertib

Timeline

• Start date: 2013-11-06
• Primary completion: 2016-12-16
• Completion: 2016-12-16
• First posted: 2013-10-08
• Last updated: 2019-02-08
• Results posted: 2019-02-08

Locations

14 sites across 2 countries: France, Germany