NCT02201329 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2018-07-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)

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outcome · POSTED

Maximum Tolerated Dose of Volasertib

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outcome · POSTED

Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)

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outcome · POSTED

Maximum Measured Concentration of the Volasertib 200 mg in Plasma (Cmax)

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outcome · POSTED

Area Under the Concentration-Time Curve of Volasertib 200 mg in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion criteria: 1. Patients of age \>=20 and \<=80 years 2. Patients with primary or treatment-related myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML), who are not eligible for hematopoietic stem cell transplantation based on the investigator's judgment, that meet one of the following 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. Exclusion criteria: 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 4. Known hypersensitivity to the trial drugs or its excipients 5. Concomitant malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer) 6. QTcF prolongation \>470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). 7. Total bilirubin \>1.5 x upper limit of normal (ULN) not related to Gilbert's syndrome, hemolysis, or secondary to MDS at screening 8. Aspartate amino transferase or alanine amino transferase \>2.5 x ULN 9. Serum creatinine \>1.5 x ULN at screening 10. Arterial oxygen pressure \<60 torr or arterial oxygen saturation \<92% (at room air) 11. Active hepatitis B or hepatitis C, or laboratory evidence of hepatitis with positive results of hepatitis B surface antigen and/or hepatitis C antibody. 12. Human immunodeficiency virus infection. 13. Severe illness or organ dysfunction involving the heart, lung, kidney, liver or other organ system, which in the opinion of the investigator would interfere with the evaluation of the safety of the study treatment including; infection requiring active treatment, poorly controlled ventricular/atrial tachyarrhythmia, use of heart pacer, unstable angina pectoris, history of myocardial infarction or severe congestive heart failure, clinically unstable cardiac or pulmonary disease 14. Any significant concurrent psychiatric disorder or social situation that according to the investigator's judgment would compromise patient's safety or compliance, interfere with consent, study participation, or interpretation of study results 15. All male patients and female patients of child bearing potential who are unwilling to use a medically acceptable method of contraception during the trial and at least 6 months after the end of study treatment (i.e. hormonal contraception, intrauterine device, condom with spermicide, etc.). Note: females are considered to be of child bearing potential unless they have been surgically sterilized or are post-menopausal (complete absence of menses for at least 12 months without other medical reasons). 16. Pregnant or nursing female patients 17. Known or suspected active alcohol or drug abuse
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Volasertib escalating doses + azacitidine
intervention Names
Drug: Azacitidine
Drug: Volasertib
label
A
type
EXPERIMENTAL

interventions

arm Group Labels
A
description
Azacitidine (subcutaneous)
name
Azacitidine
type
DRUG
arm Group Labels
A
description
Volasertib escalating doses (intravenous)
name
Volasertib
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLT was defined as any of the following Adverse Events (AEs) considered to be related to the study drug (Volasertib and/or Azacitidine). 1. Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 drug-related non-haematologic toxicity. 2. Drug-related AEs that led to inability to deliver the full dose of the study drugs (Volasertib and/or Azacitidine) according to the assigned dose level within Cycle 1. 3. Absence of haematological recovery (sustained CTCAE grade ≥3 thrombocytopenia \<50000/mm\^3 and/or neutropenia \<1000/mm\^3) after completing Cycle 1 and lasting at least until Day 57 (from Day 1 of Cycle 1) despite complete marrow blast clearance on Day 29 (\<5% blasts in the bone marrow. 4. Any other drug-related AEs that required treatment delay of ≥4 weeks between the Cycle 1 and Cycle 2 (i.e., Cycle 2 was not started until Day 57 of Cycle 1)).
measure
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
time Frame
Up to 57 days.
description
This outcome measure presents MTD of Volasertib in Combination with Azacitidine. The MTD was defined as the highest dose level at which Dose Limiting Toxicities (DLTs) were reported in not more than 1 in 6 evaluable patients during Cycle 1.
measure
Maximum Tolerated Dose of Volasertib
time Frame
Up to 57 days.

secondary Outcomes

description
This outcome measure presents overall Objective Response (CR+PR+mCR). Response to treatment was evaluated according to the International Working Group (IWG) 2006 criteria. Best response was tabulated from all available data, with each patient being classified into one of the categories defined in CR, PR, mCR.
measure
Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)
time Frame
Up to 9 months.
description
This outcome measure presents maximum measured concentration of Volasertib 200 mg in plasma (Cmax).
measure
Maximum Measured Concentration of the Volasertib 200 mg in Plasma (Cmax)
time Frame
-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.
description
This outcome measure presents area under the concentration-time curve of Volasertib 200 mg + Azacitidine 75 mg/m\^2 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
measure
Area Under the Concentration-Time Curve of Volasertib 200 mg in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
time Frame
-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.

Full study description

brief 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice