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A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies

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. Identifier: NCT00506402
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : May 5, 2009
Information provided by:
CASI Pharmaceuticals, Inc.

Brief Summary:
The main objectives of this study are to evaluate the side effects of MKC-1 and to determine a safe dose of MKC-1 for future studies in patients with hematological malignancies

Condition or disease Intervention/treatment Phase
Hematological Malignancies Myelodysplasia Agnogenic Myeloid Metaplasia Drug: MKC-1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies
Study Start Date : November 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1 Drug: MKC-1
Capsule, 30 mg and 100 mg, BID, continuous dosing

Primary Outcome Measures :
  1. Occurrence of treatment emergent adverse events [ Time Frame: Throughout study treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. IPSS ≥ 1.5 or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible.
  2. Age > 18 years.
  3. ECOG performance status of 0-2.
  4. 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 the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 48 hours before initiation of treatment on this protocol.
  5. Persistent clinically significant chronic toxicities from prior chemotherapy, surgery or radiotherapy must have resolved to NCI CTCAE Grade < 1, except for alopecia.
  6. The following laboratory results, within 10 days of MKC-1 administration (unless the abnormality is considered attributable to leukemia):

    • Serum creatinine < 2.0 mg/dL
    • Total bilirubin < ULN (unless a diagnosis of Gilbert's disease is present)
    • AST < 2.5 x ULN (upper limit of normal)
    • Serum albumin > 3.0 g/dL
  7. Signed informed consent.

Exclusion Criteria:

  1. Pre-existing hepatomegaly with disease measured as > 2 cm below the costal margin, secondary to malignancy.
  2. Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within the 10 days before the first MKC-1 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception. Pregnant and nursing patients are excluded because the effects of MKC-1 on a fetus or nursing child are unknown.
  3. Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
  4. Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
  5. Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy.
  6. Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir) due to the potential for drug interactions wth MKC-1.
  7. Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, active infection, or any psychiatric condition that would interfere with the understanding of the informed consent.

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 identifier (NCT number): NCT00506402

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Princess Margaret Hospital
Toronto, Canada
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
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Principal Investigator: Karen Yee, MD Princess Margaret Hospital, Canada
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Responsible Party: Chief Medical Officer, EntreMed, Inc. Identifier: NCT00506402    
Other Study ID Numbers: MKC-104
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009
Keywords provided by CASI Pharmaceuticals, Inc.:
Adult patients with refractory leukemias, MDS or AMM
Additional relevant MeSH terms:
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Hematologic Neoplasms
Myelodysplastic Syndromes
Primary Myelofibrosis
Neoplasms by Site
Hematologic Diseases
Pathologic Processes
Bone Marrow Diseases
Precancerous Conditions
Myeloproliferative Disorders