- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891280
Dose-escalation Study of Oral CX-4945
June 13, 2011 updated by: Cylene Pharmaceuticals
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Advanced Solid Tumors, Castleman's Disease or Multiple Myeloma
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer.
CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers.
CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity.
This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects of CX-4945 administered to patients with malignancies or lymphoproliferative disorders known to overexpress CK2 including advanced solid tumors, Multiple Myeloma and Castleman's Disease.
Study Type
Interventional
Enrollment (Anticipated)
55
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
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic Arizona
-
Principal Investigator:
- Donald Northfelt, MD
-
Contact:
- Clinical Trials Office Mayo Clinic Cancer Center
- Phone Number: 507-538-7623
-
-
Colorado
-
Fort Collins, Colorado, United States, 80528
- Recruiting
- Front Range Cancer Specialists
-
Contact:
- P. Zeller
- Phone Number: 970-212-7609
-
Principal Investigator:
- Robert F Marschke, MD
-
Loveland, Colorado, United States, 80528
- Recruiting
- Front Range Cancer Specialists
-
Contact:
- Pat Zeller
- Phone Number: 970-212-7609
-
Principal Investigator:
- R. McFarland, MD
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- U T M D Anderson Cancer Center
-
Contact:
- R. Alvarez, MD
- Email: ralvarez@mdanderson.org
-
Principal Investigator:
- R. Alvarez, MD
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Histologically or cytologically confirmed malignancy or lymphoproliferative disorder known to over express CK2 which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available, including the following types: (examples)
- Lung cancer
- Renal cell cancer
- Breast cancer
- Inflammatory breast cancer
- Head and neck cancer - squamous cell
- Prostate cancer
- Colorectal cancer
- Castleman's disease (multi-centric disease)
- Multiple myeloma (Eligible patients must have quantifiable M-protein levels present in serum and/or urine)
- At least 18 years of age.
- One or more tumors measurable on radiograph or CT scan, or evaluable disease defined as non-measurable lesions per RECIST or detection of protein M in serum and/or urine of patients with Multiple Myeloma (serum ≥ 10 gm/L and urine ≥ 200 mg/24 hr).
- Laboratory data as specified below:
- Hematology: ANC >1500 cells/mm3, platelet count >100,000 cells/mm3 and Hemoglobin > 9 gm/L
- Hepatic: bilirubin <1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN
- Renal: serum creatinine within normal limits (WNL), defined as within 10% of the institution's stated reference range, or a calculated creatinine clearance >60 mL/min/1.73 m2 for patients with abnormal, increased, creatinine levels. Patients with Multiple Myeloma (only): serum creatinine ≤ 2.5 the institutional upper limit of the normal range and a calculated creatinine clearance > 40 mL/min/1.73 m2.
- Coagulation: INR < 1.5 times normal, aPTT < 1.5 times normal. Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible for the trial if INR and aPTT are within the acceptable therapeutic limits for the institution.
- A negative pregnancy test (if female of childbearing potential).
- Estimated life expectancy of at least 3 months
- Karnofsky Performance Status ≥ 70%
- For men and women of child-producing potential, use of effective contraceptive methods during the study
- Ability to understand the requirements of the study, provide written informed consent.
Exclusion Criteria:
- Pregnant or nursing women.
- Seizure disorders requiring anticonvulsant therapy.
- Known brain metastases (unless previously treated and well controlled for a period of > or = 3 months).
- Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
- Treatment with radiation therapy or surgery within one month prior to study entry
- Treatment with chemotherapy or investigational drugs within 21 days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
- Patients with a history of a second malignancy within 3 years of the baseline visit excluding cutaneous carcinomas and in-situ carcinoma.
- Concurrent severe or uncontrolled medical disease.
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis.
- Difficulty with swallowing or an active malabsorption syndrome
- Chronic diarrhea
- Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
- History of gastric or small bowel surgery involving any extent of gastric or small bowel resection.
- Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis
- Patients who have exhibited allergic reactions to a similar structural compound or to a formulation component.
- Concomitant use of warfarin and HMG-CoA reductase inhibitors (statins)
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)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety (Dose limiting toxicities, maximum tolerated dose)
Time Frame: One year (Assessed at Cycle 1)
|
One year (Assessed at Cycle 1)
|
Drug-related adverse events
Time Frame: One Year (Asessed from first administration of study drug through 30 days after the last dose)
|
One Year (Asessed from first administration of study drug through 30 days after the last dose)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic and pharmacodynamic assessments
Time Frame: One Year (Assessed during Cycle 1)
|
One Year (Assessed during Cycle 1)
|
Observe evidence of antitumor activity
Time Frame: One Year (Assessed after every two cycles)
|
One Year (Assessed after every two cycles)
|
Establish the recommended Phase 2 dose
Time Frame: One Year (Study completion)
|
One Year (Study completion)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Cylene Pharmaceuticals
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
February 1, 2009
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
April 29, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (Estimate)
May 1, 2009
Study Record Updates
Last Update Posted (Estimate)
June 15, 2011
Last Update Submitted That Met QC Criteria
June 13, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Breast Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Breast Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Castleman Disease
- Inflammatory Breast Neoplasms
Other Study ID Numbers
- C4-08-001
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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