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Acute Myeloid LeukemiaPhase 2PAZOPANIB-AMLNCT01361334

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible

A Phase 2 study testing Pazopanib in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.

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

Long term disease-free survival (DFS) of patients with acute myeloid leukemia (AML) is still poor. Recently, so-called "targeted therapy" for cancer has been introduced to the treatment of patients with AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
Jun 2011to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (AML), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
  • Histologically or cytologically confirmed diagnosis of AML relapsed after or refractory to at least one induction regimen, or patients with AML at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for AML M3 (acute promyelocytic leukemia)
  • Age at least 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤3
  • Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])
  • Able to swallow and retain oral medication
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  • A life expectancy of at least 4 weeks
  • Adequate contraception methods
  • Adequate organ function as defined in the study protocol

Who cannot join

  • Patients with a valid option for intensive chemotherapy and/or stem cell transplantation (Patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and Graft-versus host disease must have resolved to Grade ≤2)
  • History of cancer that according to the Investigator might confound the assessment of the endpoints of the study
  • Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
  • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥90 mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
  • Prolongation of corrected QT interval (QTc) >480 milliseconds
  • History of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
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  • History of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
  • Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML-related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
  • Prior major surgery or trauma within 28 days prior to first dose of study drug
  • Treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
  • Concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
  • Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
  • Pregnant or lactating and actively breastfeeding patients
  • Patients taking any of the following prohibited medication:
  • clarithromycin, telithromycin, troleandomycin (antibiotics)
  • ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)
  • itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
  • nefazodone (antidepressant)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Unviersity Hospital of Münster (UKM)

    Münster, 48149

Other trials in Germany

About this study

Official title: Phase II Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible

Long term disease-free survival (DFS) of patients with acute myeloid leukemia (AML) is still poor. Recently, so-called "targeted therapy" for cancer has been introduced to the treatment of patients with AML. This phase II clinical trial will explore the efficacy, safety, and pharmacodynamics of the tyrosine kinase inhibitor pazopanib in patients with relapsed or refractory AML or patients with AML who are not eligible for intensive treatment. Biomarker studies will be included to study whether the targets are indeed inhibited and whether this leads to decreased BM angiogenesis. Toxicity assessments will be included, and the antileukemic effectiveness will be studied.

Being tested
Pazopanib
Keywords
(other than AML M3)
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.

  • PazopanibDrug

    Also called Votrient(R)

    800 mg QD p.o.

Study groups in NCT01361334
Study groupRoleWhat they receive
PazopanibExperimentalPazopanib treatment
Receives: Drug: Pazopanib

What is being measured

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

  1. Cumulative response rate (CR, CRp, CRi, PR) within up to one year of pazopanib treatment

    Measured: 12 months

  2. Reduction of BM microvessel density on day 28

    Measured: 28 days

Secondary outcomes (4)

  1. Safety and Tolerability (Rate of adverse events)

    Rate of adverse events

    Measured: 12 months

  2. Cumulative incidence and degree of inhibition of target receptor phosphorylation (PDGFR, VEGFR, and c-KIT) and correlation with clinical response

    Measured: 12 months

  3. Reduction of BM microvessel density on day 14

    Measured: 14 days

  4. Relapse-free survival in relationship to historical control patients, Overall survival in relationship to historical control patients, Duration of response

    Measured: 12 months

Timeline

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

  1. First posted26 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01361334
Sponsor's protocol ID
UKM09_0018_PAZOPANIB_AML 2011
Other IDs
2010-024526-37
Acronym
PAZOPANIB-AML
Status last verified
May 2016
First submitted
17 May 2011
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Kessler T, Koschmieder S, Schliemann C, Crysandt M, Mikesch JH, von Stillfried S, Stelljes M, Pohlen M, Lenz G, Kirsch A, Vehring K, Wardelmann E, Hartmann W, Bormann E, Gerss J, Brummendorf TH, Muller-Tidow C, Berdel WE. Phase II clinical trial of pazopanib in patients with acute myeloid leukemia (AML), relapsed or refractory or at initial diagnosis without an intensive treatment option (PazoAML). Ann Hematol. 2019 Jun;98(6):1393-1401. doi: 10.1007/s00277-019-03651-9. Epub 2019 Mar 21.

    PubMed 30903275

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.

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 9 inclusion and 19 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cumulative response rate (CR, CRp, CRi, PR) within up to one year of pazopanib treatment (time frame: 12 months). 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 NCT01361334, which also lists 1 linked publication.

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 8 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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