- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398462
Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients
March 7, 2016 updated by: JW Pharmaceutical
A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis
CWP232291 blocks proliferation of cancer cells via activation of caspases.
Active caspase have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for degradation through caspase-directed cleavage.
CWP232291 targets beta-catenin for degradation and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1 and survivin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 1
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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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Samsung Medical Center
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Texas
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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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:
- Able to understand and willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment
- 18 years of age
- 3. A pathologically confirmed diagnosis of AML or CMML-2 by World Health Organization (WHO) classification that is relapsed or refractory or for which no current therapies are anticipated to result in a durable remission, or MDS by WHO classification are RAEB-1 or RAEB-2 and that have failed at least three cycles of hypomethylating therapy, or primary (PMF), post-polycythemia vera (PPMF) or post-essential thrombocythemia (PTMF) MF by WHO classification, are high-risk category by the Dynamic International Prognostic Scoring System (DIPSS Plus), have ≥1% circulating blasts, and have failed treatment with ruxolitinib
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. If a patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must have discontinued hydroxyurea for at least 24 hours before initiation of treatment with study drug. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade 1
Adequate renal function:
- Serum creatinine =/< 2.0mg/dL
Adequate hepatic function:
- Total bilirubin <1.5 x upper limit of normal (ULN), unless considered due to Gilbert's syndrome
- Alkaline phosphatase (AP) =/< 2.5 x ULN
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≤3 x ULN, unless considered due to organ leukemic involvement
- Women of child-bearing potential (i.e., women who are pre menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive, or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study
- Able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure (CHF), cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- Active heart disease including myocardial infarction (MI) within previous 3 months, symptomatic coronary artery disease (CAD), arrhythmias not controlled by medication, or uncontrolled CHF
- Active central nervous system (CNS) disease
- Therapy with any other standard or investigational treatment for hematologic malignancy (except hydroxyurea, as mentioned in the inclusion criteria)
- Therapy with anticoagulant or antithrombotic agents (including aspirin) within 7 days prior to study drug administration
- History of gastrointestinal (GI) hemorrhage
- Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C
- Pregnant or nursing women. Pregnant and nursing patients are excluded because the effects of CWP232291 on a fetus or nursing child are unknown.
- Patients eligible for bone marrow transplant, regardless of age
- Patients with FLT3 ITD positive AML or AML patients with other cytogenetic abnormalities who are eligible for trials of other targeted investigational agents from which the investigator feels there is greater benefit.
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: CWP232291
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IV Infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose
Time Frame: Up to 3 weeks after start of injection
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If myelosuppression is DLT (Dose-Limiting Toxicity), it will be monitored up to 42 days after start of injection.
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Up to 3 weeks after start of injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax as a pharmacokinetic parameter of 'CWP232291'
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Peak Plasma Concentration (Cmax) of 'CWP232291'
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0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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AUC as a pharmacokinetic parameter of 'CWP232291'
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Area under the plasma concentration versus time curve (AUC) of 'CWP232291'
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0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Cmax as a pharmacokinetic parameter of metabolites of 'CWP232291'
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'
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0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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AUC as a pharmacokinetic parameter of metabolites of 'CWP232291'
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'
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0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2011
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 17, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 20, 2011
Study Record Updates
Last Update Posted (Estimate)
March 8, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Precancerous Conditions
- Myelodysplastic-Myeloproliferative Diseases
- Myelodysplastic Syndromes
- Primary Myelofibrosis
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
Other Study ID Numbers
- JW-231A-101
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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