- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361334
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 (PAZOPANIB-AML)
April 6, 2021 updated by: University Hospital Muenster
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Münster, Germany, 48149
- Unviersity Hospital of Münster (UKM)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- A life expectancy of at least 4 weeks
- Adequate contraception methods
- Adequate organ function as defined in the study protocol
Exclusion Criteria:
- 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)
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pazopanib
Pazopanib treatment
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800 mg QD p.o.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative response rate (CR, CRp, CRi, PR) within up to one year of pazopanib treatment
Time Frame: 12 months
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12 months
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Reduction of BM microvessel density on day 28
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability (Rate of adverse events)
Time Frame: 12 months
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Rate of adverse events
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12 months
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Cumulative incidence and degree of inhibition of target receptor phosphorylation (PDGFR, VEGFR, and c-KIT) and correlation with clinical response
Time Frame: 12 months
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12 months
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Reduction of BM microvessel density on day 14
Time Frame: 14 days
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14 days
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Relapse-free survival in relationship to historical control patients, Overall survival in relationship to historical control patients, Duration of response
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Torsten Kessler, MD, University of Münster, Department of Medicine A, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 25, 2011
First Posted (Estimate)
May 26, 2011
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 6, 2021
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKM09_0018_PAZOPANIB_AML 2011
- 2010-024526-37 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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