Dose-escalation Study of Oral CX-4945

NCT00891280 | Unknown Phase 1

• 1 other identifier: C4-08-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety (Dose limiting toxicities, maximum tolerated dose)

  One year (Assessed at Cycle 1)

• Drug-related adverse events

  One Year (Asessed from first administration of study drug through 30 days after the last dose)

Secondary Outcomes (3)

• Pharmacokinetic and pharmacodynamic assessments

  One Year (Assessed during Cycle 1)

• Observe evidence of antitumor activity

  One Year (Assessed after every two cycles)

• Establish the recommended Phase 2 dose

  One Year (Study completion)

Interventions

CX-4945 oral formulation DRUG

CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cylene Pharmaceuticals: lead

Study Sites (4)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

RECRUITING

Front Range Cancer Specialists

Loveland, Colorado, 80528, United States

RECRUITING

U T M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms; Castleman Disease; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Study Director

  Cylene Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 1, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

US (4)