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

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: CX-4945	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Cylene Pharmaceuticals:

Primary Outcome Measures:

Safety [ Time Frame: One year (assessed at Cycle 1). ] [ Designated as safety issue: Yes ]
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.

Secondary Outcome Measures:

Pharmacokinetic and pharmacodynamic assessments. [ Time Frame: One year - assessed throughout all cycles of participation ] [ Designated as safety issue: No ]
Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.
Assess for efficacy response [ Time Frame: One year (assessed after each cycle) ] [ Designated as safety issue: No ]
Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.
Establish the recommended Phase 2 dose [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	22
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CX-4945 CX-4945 oral formulation	Drug: CX-4945 CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199718

Locations

United States, Ohio
	Recruiting
Kettering, Ohio, United States, 45249
Contact: Michelle Owens, RN michelle.owens@khnetwork.org
United States, Oregon
Oregon Health Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Farnoush Abar, MD abarfa@ohsu.edu
	Recruiting
Springfield, Oregon, United States, 97477
Contact: Jeanne Schaffer, RN jeanne.schaffer@usoncology.com
United States, South Carolina
	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jan Kueber, RN jkueber@ghs.org
United States, Virginia
	Recruiting
Norfolk, Virginia, United States, 23502
Contact: Gabrielle Geho, RN Gabrielle.Geho@usoncology.com
United States, Washington
	Recruiting
Yakima, Washington, United States, 98902
Contact: Jo Cook jo.cook@yvmh.org

Sponsors and Collaborators

Cylene Pharmaceuticals

Investigators

Study Director:

Study Director

Cylene Pharmaceuticals

More Information

No publications provided

Responsible Party:	Study Director, Cylene Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01199718 History of Changes
Other Study ID Numbers:	C4-09-001
Study First Received:	September 9, 2010
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cylene Pharmaceuticals:

Multiple myeloma
Plasmacytoma

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013