Recruiting
Phase 1

CX-4945

Sponsor:

Cylene Pharmaceuticals

Code:

NCT01199718

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CX-4945

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 relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Study ID

NCT01199718

Start date

Sep, 2010

Status verified date

Jun, 2011

Completion date

Sep, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CX-4945

CX-4945 oral formulation

Interventions

CX-4945

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

Primary outcome measure

  • Safety [ Time Frame: One year (assessed at Cycle 1). ]

Central Contacts and Locations

Locations

Recruiting

Kettering, Ohio, United States, 45249

Contacts

Michelle Owens, RN

michelle.owens@khnetwork.org

Oregon Health Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Farnoush Abar, MD

abarfa@ohsu.edu

Recruiting

Springfield, Oregon, United States, 97477

Contacts

Jeanne Schaffer, RN

jeanne.schaffer@usoncology.com

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Jan Kueber, RN

jkueber@ghs.org

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Gabrielle Geho, RN

Gabrielle.Geho@usoncology.com

Recruiting

Yakima, Washington, United States, 98902

Contacts

Jo Cook

jo.cook@yvmh.org

More Information

Sponsor

Cylene Pharmaceuticals

Last update posted

Jun 15, 2011

Last verified

Jun, 2011

Keywords

  • Multiple myeloma
  • Plasmacytoma

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.