Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01199718
• Other study ID #: C4-09-001
• Status: Recruiting
• Phase: Phase 1
• First received: September 9, 2010
• Last updated: June 13, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2011
• Source: Cylene Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 relapsed or refractory multiple myeloma.

Description:

Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, 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, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females at least 18 years of age

• Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.

• Measureable disease.

• Karnofsky Performance Status at least 60%

• Adequate liver and renal function and hematology laboratory values

• Female patients of child-bearing potential must have a negative pregnancy test.

• Signed informed consent.

Exclusion Criteria:

• Treatment with systemic cancer therapy within 21 days before screening.

• Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.

• Grade 3 sensory neuropathy or motor neuropathy with pain

• Concurrent severe or uncontrolled medical disease.

• Active systemic fungal, bacterial, and/or viral infection.

• Difficulty with swallowing, or an active malabsorption syndrome.

• Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.

• History of gastric or small bowel surgery.

• Pregnant or nursing females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CX-4945
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.

Locations

Country	Name	City	State
United States	Oregon Health Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Cylene Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.	One year (assessed at Cycle 1).	Yes
Secondary	Pharmacokinetic and pharmacodynamic assessments.	Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.	One year - assessed throughout all cycles of participation	No
Secondary	Assess for efficacy response	Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.	One year (assessed after each cycle)	No
Secondary	Establish the recommended Phase 2 dose		One year	Yes