We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01398462
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : March 8, 2016
Information provided by (Responsible Party):
JW Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Myelofibrosis Drug: CWP232291 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: CWP232291 Drug: CWP232291
IV Infusion

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: Up to 3 weeks after start of injection ]
    If myelosuppression is DLT (Dose-Limiting Toxicity), it will be monitored up to 42 days after start of injection.

Secondary Outcome Measures :
  1. Cmax as a pharmacokinetic parameter of 'CWP232291' [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose ]
    Peak Plasma Concentration (Cmax) of 'CWP232291'

  2. AUC as a pharmacokinetic parameter of 'CWP232291' [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose ]
    Area under the plasma concentration versus time curve (AUC) of 'CWP232291'

  3. 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 ]
    Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'

  4. 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 ]
    Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398462

Layout table for location information
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01398462    
Other Study ID Numbers: JW-231A-101
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Primary Myelofibrosis
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases