- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506402
A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies
May 4, 2009 updated by: CASI Pharmaceuticals, Inc.
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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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-
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Toronto, Canada
- Princess Margaret Hospital
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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:
- 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.
- Age > 18 years.
- ECOG performance status of 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 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.
- Persistent clinically significant chronic toxicities from prior chemotherapy, surgery or radiotherapy must have resolved to NCI CTCAE Grade < 1, except for alopecia.
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
- Signed informed consent.
Exclusion Criteria:
- Pre-existing hepatomegaly with disease measured as > 2 cm below the costal margin, secondary to malignancy.
- 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.
- Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
- Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy.
- Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir) due to the potential for drug interactions wth MKC-1.
- 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.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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Capsule, 30 mg and 100 mg, BID, continuous dosing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of treatment emergent adverse events
Time Frame: Throughout study treatment
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Throughout study treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Yee, MD, Princess Margaret Hospital, Canada
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
November 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
July 24, 2007
First Submitted That Met QC Criteria
July 24, 2007
First Posted (Estimate)
July 25, 2007
Study Record Updates
Last Update Posted (Estimate)
May 5, 2009
Last Update Submitted That Met QC Criteria
May 4, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKC-104
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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