Trials / Completed
CompletedNCT02201329
Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
An Open Label Phase I Trial of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Japanese Patients With Higher-risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability, pharmacokinetics and the preliminary efficacy of this combination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine | Azacitidine (subcutaneous) |
| DRUG | Volasertib | Volasertib escalating doses (intravenous) |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-01-01
- Completion
- 2015-09-01
- First posted
- 2014-07-28
- Last updated
- 2018-07-30
- Results posted
- 2018-07-30
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02201329. Inclusion in this directory is not an endorsement.