Phase 1 N=5 Treatment

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

Myelodysplastic Syndromes · Leukemia, Myelomonocytic, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02201329 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Jul 2018

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) — 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Azacitidine (Drug); Volasertib (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)	2	—
PRIMARY Maximum Tolerated Dose of Volasertib	NA	—
SECONDARY Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)	2; 0; 0; 2	—
SECONDARY Maximum Measured Concentration of the Volasertib 200 mg in Plasma (Cmax)	713	—
SECONDARY Area Under the Concentration-Time Curve of Volasertib 200 mg in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	4190	—

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 Criteria

Inclusion criteria

Patients of age >=20 and = 10% marrow blasts without myeloproliferative disorder (white blood cell count of 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).
Total bilirubin >1.5 x upper limit of normal (ULN) not related to Gilbert's syndrome, hemolysis, or secondary to MDS at screening
Aspartate amino transferase or alanine amino transferase >2.5 x ULN
Serum creatinine >1.5 x ULN at screening
Arterial oxygen pressure <60 torr or arterial oxygen saturation <92% (at room air)
Active hepatitis B or hepatitis C, or laboratory evidence of hepatitis with positive results of hepatitis B surface antigen and/or hepatitis C antibody.
Human immunodeficiency virus infection.
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
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
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).
Pregnant or nursing female patients
Known or suspected active alcohol or drug abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02201329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.