Leukemia, Myeloid, AcutePhase 1NCT01662505

Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

A Phase 1 study testing Volasertib in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Leukemia, Myeloid, Acute
What is being tested?: Volasertib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 6 sitesJapan
Study dates: Aug 2012to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL) according to the World Health Organization definition and with one of the following features at screening
Relapsed or refractory AML
Untreated AML patients not considered to be suitable for standard induction therapy according to investigator's judgement
Male or female patients of age >/= 18 years at the time of informed consent
Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
Signed written informed consent consistent with Japanese Good Clinical Practice.

Who cannot join

Patients with APL
Patients in the third or later relapse
Prior stem cell transplantation
Treatment with systemic therapy for the primary disease (including an investigational drug) within 14 days before the first dose of volasertib with the exception of hydroxyurea, or lack of recovery from any acute toxicities or clinically significant adverse events pertinent to the prior systemic therapy
Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib
Concomitant medication/treatment with anti-leukemic chemotherapy (systemic or intrathecal), radiotherapy, immunotherapy, or any investigational agent while receiving study treatment
Other malignancy requiring treatment at the time of screening
Clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement or requiring treatment

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Boehringer Ingelheim Investigational Site
Isehara, Kanagawa
Boehringer Ingelheim Investigational Site
Maebashi, Gunma,
Boehringer Ingelheim Investigational Site
Nagasaki, Nagasaki
Boehringer Ingelheim Investigational Site
Nagoya-shi, Aichi
Boehringer Ingelheim Investigational Site
Yoshida-gun, Fukui

Other trials in Japan

About this study

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

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

Conditions: Leukemia, Myeloid, Acute
Being tested: Volasertib
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VolasertibDrug
Patient to receive volasertib

Study groups in NCT01662505
Study group	Role	What they receive
Volasertib	Experimental	Patient to receive escalating dose of volasertib Receives: Drug: Volasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
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.
Measured: From first administration of trial drug up to 28 days
MTD of Volasertib
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.
Measured: From first administration of trial drug up to 28 days

Secondary outcomes (4)

Best Response by Complete Remission (CR)
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.
Measured: From first administration of trial drug up to 486 days
Best Response by CRi
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]).
Measured: From first administration of trial drug up to 486 days
Best Response by PR
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%.
Measured: From first administration of trial drug up to 486 days
Remission Duration
The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.
Measured: From first administration of trial drug up to 486 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012May 2015

First posted10 Aug 2012 (estimated)
Study startAug 2012
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01662505
Sponsor's protocol ID: 1230.26
Status last verified: Oct 2017
First submitted: 8 Aug 2012
Last updated: 30 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Leukemia, Myeloid, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT01662505
Acronym / sponsor ID: 1230.26
Conditions: Leukemia, Myeloid, Acute
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 10 Aug 2012 (estimated)
Results: Posted 30 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Volasertib	Experimental	Drug: VolasertibPatient to receive escalating dose of volasertib

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL) according to the World Health Organization definition and with one of the following features at screening
Male or female patients of age >/= 18 years at the time of informed consent
Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
Signed written informed consent consistent with Japanese Good Clinical Practice.

Key exclusion criteria (8 listed)

Patients with APL
Patients in the third or later relapse
Prior stem cell transplantation
Treatment with systemic therapy for the primary disease (including an investigational drug) within 14 days before the first dose of volasertib with the exception of hydroxyurea, or lack of recovery from any acute toxicities or clinically significant adverse events pertinent to the prior systemic therapy
Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VolasertibPatient to receive volasertib	Drug	Volasertib

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
Time frame: From first administration of trial drug up to 28 days
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.
MTD of Volasertib
Time frame: From first administration of trial drug up to 28 days
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.

4 secondary outcomes

Best Response by Complete Remission (CR)
Time frame: From first administration of trial drug up to 486 days
Best Response by CRi
Time frame: From first administration of trial drug up to 486 days
Best Response by PR
Time frame: From first administration of trial drug up to 486 days
Remission Duration
Time frame: From first administration of trial drug up to 486 days

Results and safety

Results posted to the registry on 30 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V 350 mg	7	0
V 400 mg	4	0
V 450 mg	8	0

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

Time frame: From first administration of trial drug up to 28 days. Number. Unit: Participants

Measure	V 350 mg n = 7	V 400 mg n = 4	V 450 mg n = 8
Value	0	0	1

Population analysed: Treated Set

Primary outcome: MTD of Volasertib

Time frame: From first administration of trial drug up to 28 days. Number. Unit: milligram (mg)

Measure	Volasertib n = 8
Value	450

Population analysed: Treated Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From inclusion into the study to 21 days after last drug administration (up to 507 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V 350 mg	3 of 7 (42.9%)	7 of 7 (100%)	Not reported
V 400 mg	0 of 4 (0%)	4 of 4 (100%)	Not reported
V 450 mg	4 of 8 (50%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Leukemia, Myeloid, Acute

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Volasertib in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib (time frame: From first administration of trial drug up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01662505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.