Dose-escalation Study of Oral CX-4945
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ClinicalTrials.gov Identifier: NCT00891280 |
Recruitment Status : Unknown
Verified June 2011 by Cylene Pharmaceuticals.
Recruitment status was: Recruiting
First Posted : May 1, 2009
Last Update Posted : June 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors Breast Cancer Inflammatory Breast Cancer Castleman's Disease Multiple Myeloma | Drug: CX-4945 oral formulation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2011 |

- Drug: CX-4945 oral formulation
CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.
- Safety (Dose limiting toxicities, maximum tolerated dose) [ Time Frame: 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) ]
- Pharmacokinetic and pharmacodynamic assessments [ Time Frame: One Year (Assessed during Cycle 1) ]
- Observe evidence of antitumor activity [ Time Frame: One Year (Assessed after every two cycles) ]
- Establish the recommended Phase 2 dose [ Time Frame: One Year (Study completion) ]

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

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): NCT00891280
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact: Clinical Trials Office Mayo Clinic Cancer Center 507-538-7623 | |
Principal Investigator: Donald Northfelt, MD | |
United States, Colorado | |
Front Range Cancer Specialists | Recruiting |
Fort Collins, Colorado, United States, 80528 | |
Contact: P. Zeller 970-212-7609 | |
Principal Investigator: Robert F Marschke, MD | |
Front Range Cancer Specialists | Recruiting |
Loveland, Colorado, United States, 80528 | |
Contact: Pat Zeller 970-212-7609 | |
Principal Investigator: R. McFarland, MD | |
United States, Texas | |
U T M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: R. Alvarez, MD ralvarez@mdanderson.org | |
Principal Investigator: R. Alvarez, MD |
Study Director: | Study Director | Cylene Pharmaceuticals |
Responsible Party: | Study Director, Cylene Pharmaceuticals Inc |
ClinicalTrials.gov Identifier: | NCT00891280 |
Other Study ID Numbers: |
C4-08-001 |
First Posted: | May 1, 2009 Key Record Dates |
Last Update Posted: | June 15, 2011 |
Last Verified: | June 2011 |
Inflammatory breast cancer Castleman's Disease Multiple Myeloma |
Breast cancer Solid tumors CK2 inhibitor |
Breast Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Inflammatory Breast Neoplasms Castleman Disease Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms by Histologic Type Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lymphatic Diseases |