Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01199718|
Recruitment Status : Unknown
Verified June 2011 by Cylene Pharmaceuticals.
Recruitment status was: Recruiting
First Posted : September 13, 2010
Last Update Posted : June 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CX-4945||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||September 2011|
CX-4945 oral formulation
CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
- Safety [ Time Frame: One year (assessed at Cycle 1). ]Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
- Pharmacokinetic and pharmacodynamic assessments. [ Time Frame: One year - assessed throughout all cycles of participation ]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) ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199718
|United States, Ohio|
|Kettering, Ohio, United States, 45249|
|Contact: Michelle Owens, RN email@example.com|
|United States, Oregon|
|Oregon Health Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Farnoush Abar, MD firstname.lastname@example.org|
|Springfield, Oregon, United States, 97477|
|Contact: Jeanne Schaffer, RN email@example.com|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29605|
|Contact: Jan Kueber, RN firstname.lastname@example.org|
|United States, Virginia|
|Norfolk, Virginia, United States, 23502|
|Contact: Gabrielle Geho, RN Gabrielle.Geho@usoncology.com|
|United States, Washington|
|Yakima, Washington, United States, 98902|
|Contact: Jo Cook email@example.com|
|Study Director:||Study Director||Cylene Pharmaceuticals|