Recruiting
Phase 1

CX-4945

Sponsor:

Cylene Pharmaceuticals

Code:

NCT00891280

Conditions

Advanced Solid Tumors

Breast Cancer

Inflammatory Breast Cancer

Castleman's Disease

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CX-4945 oral formulation

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Breast Cancer

Inflammatory Breast Cancer

Castleman's Disease

Multiple Myeloma

Study ID

NCT00891280

Start date

Feb, 2009

Status verified date

Jun, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Office Mayo Clinic Cancer Center

507-538-7623

Principal Investigator:

Donald Northfelt, MD

Front Range Cancer Specialists

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

P. Zeller

970-212-7609

Principal Investigator:

Robert F Marschke, MD

Front Range Cancer Specialists

Recruiting

Loveland, Colorado, United States, 80528

Contacts

Pat Zeller

970-212-7609

Principal Investigator:

R. McFarland, MD

U T M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

R. Alvarez, MD

ralvarez@mdanderson.org

Principal Investigator:

R. Alvarez, MD

More Information

Sponsor

Cylene Pharmaceuticals

Last update posted

Jun 15, 2011

Last verified

Jun, 2011

Keywords

  • Inflammatory breast cancer
  • Castleman's Disease
  • Multiple Myeloma
  • Breast cancer
  • Solid tumors
  • CK2 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cylene Pharmaceuticals on 2011-06-15.