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Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02201329•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of age \>=20 and \<=80 years

Exclusion Criteria

•* Intermediate-2 and high-risk MDS according to the International Prognostic Scoring System, in the setting of 5-30% bone marrow blasts
•* CMML with \>= 10% marrow blasts without myeloproliferative disorder (white blood cell count of \<13,000/ µL)
•3. Patients with no prior azacitidine treatment, or with prior azacitidine treatment that meet one of the following criteria:
•* Patients failing to achieve haematological improvement, partial remission, marrow complete remission or complete remission after 3 cycles of azacitidine or progressed at any time after start of azacitidine
•* Patients achieved an initial response and subsequently develop disease progression or relapse
•4. Eastern Cooperative Oncology Group performance status score 0 or 1 at screening
•5. Signed written informed consent consistent with Good Clinical Practice.
•1. Treatment with systemic therapy for MDS, including an investigational drug, within 14 days before the first dose of study treatment, except for lenalidomide within 12 weeks before the first dose of study treatment, or lack of recovery from any acute toxicities pertinent to the prior systemic therapy.
•2. Prior treatment with volasertib
•3. Contraindications for azacitidine treatment according to the manufacturer's product information
+14 more criteria

Locations (4)

Boehringer Ingelheim Investigational Site

Aichi, Nagoya, Japan

Boehringer Ingelheim Investigational Site

Gunma, Maebashi, Japan

Boehringer Ingelheim Investigational Site

Nagasaki, Nagasaki, Japan

Boehringer Ingelheim Investigational Site

Tokyo, Sinagawa-ku, Japan

Key Dates

Start Date

August 1, 2014

Primary Completion Date

January 1, 2015

Completion Date

September 1, 2015

Last Updated

July 30, 2018

Enrollment

ACTUAL participants

Conditions

Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic

Interventions

Azacitidine

DRUG

Volasertib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Inclusion Criteria

Exclusion Criteria

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