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Patient to receive escalating dose of volasertib

Volasertib

Boehringer Ingelheim

To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML

Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia

Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented.

Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented.

The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR).

In this outcome measure the CR will be presented.

The criteria for the CR are:

Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \>1.0 × 10\^9/Litre (L) (1000/microlitre (μL)); platelet count \>100 × 10\^9/L (100 000/μL); independence of red cell transfusions.

The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented.

The criteria for the CRi are:

All CR criteria are met except for residual neutropenia (\<1.0 × 10\^9/L \[1000/μL\]) or thrombocytopenia (\<100 × 10\^9/L \[100 000/μL\]).

The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented.

The criteria for the PR are:

All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.

Patients received 350 milligram (mg) of Volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.

V 350 mg

Patients received 400 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.

V 400 mg

Patients received 450 mg of Volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.

V 450 mg

Patients received 350 milligram (mg) of volasertib (V) as monotherapy on Days 1 and 15 of a 28-day cycle via intravenous (i.v.) drip infusion over 2 hours.

Patients received 400 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.

Patients received 450 mg of volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.

Total

Age, Continuous

Sex: Female, Male

Treated Set (TS): All patients that received at least 1 dose of the trial medication were defined as the treated set.

Boehringer Ingelheim, Call Center

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib

Best Response by Complete Remission (CR)

Patients received volasertib as monotherapy on Days 1 and 15 of a 28-day cycle via i.v. drip infusion over 2 hours.

Spots Global Cancer Trial Database for Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

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