AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01085214|
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Other: Laboratory Biomarker Analysis Drug: Selumetinib||Phase 2|
I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM).
I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2.
Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of AZD6244 in Multiple Myeloma|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: AZD6244 (Selumetinib) Treatment
Participants receive AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles
- Overall Response Rate [ Time Frame: Up to 2 years ]Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).
- Duration of Response [ Time Frame: From response to disease progression or death, assessed up to 2 years ]Mean duration of response in months. Estimated using the method of Kaplan-Meier.
- Incidence of Toxicity That May Be Treatment Emergent [ Time Frame: 1 year, 11 months ]Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
- Progression Free Survival (PFS) [ Time Frame: From registration to progression or death, assessed up to 2 years ]Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.
- Changes in Bone Marrow Microenvironment [ Time Frame: Baseline to up to 20-30 hours after receiving the first dose of AZD6244 ]Effect of AZD6244 on the bone marrow microenvironment in MM.
- Level of Key Regulators [ Time Frame: Up to 20-30 hours after receiving the first dose of selumetinib ]The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085214
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|Mark O Hatfield-Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892|
|National Institutes of Health|
|Bethesda, Maryland, United States, 20892|
|United States, Montana|
|Billings Clinic Cancer Center|
|Billings, Montana, United States, 59107|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Steven Grant, M.D.||Massey Cancer Center|