Selumetinib and Cixutumumab in Treating Patients With Advanced Solid Malignancies
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|ClinicalTrials.gov Identifier: NCT01061749|
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Solid Neoplasm||Biological: Cixutumumab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Selumetinib||Phase 1|
I. Determine the safety and toxicity of the combination of AZD6244 and IMC-A12 in advanced solid tumors that have progressed on standard therapy.
II. Finding the maximum tolerated dose (MTD)/recommended phase II dose of the combination.
I. Explore preliminary evidence of efficacy of the combination of AZD6244 and IMC-A12 in advanced solid tumors using RECIST criteria for tumor response.
II. Define pharmacodynamic (PD) profile of the combination of IMC-A12 and AZD6244.
III. Correlate pharmacokinetics (PK) of the combination of IMC-A12 and AZD6244 to pharmacodynamic (PD) endpoints.
IV. Assess the PK/PD (phospho-S6) link with AZD6244 when administered in combination with IMC-A12.
OUTLINE: This is a dose-escalation study of selumetinib and cixutumumab.
Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28 and cixutumumab intravenously (IV) on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Single-Institution Open Label, Dose-Escalation Trial With an Expansion Trial Cohort Evaluating the Safety and Tolerability of AZD6244 and IMC-A12 in Subjects With Advanced Solid Malignancies|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||September 2014|
Experimental: Treatment (selumetinib, cixutumumab)
Patients receive selumetinib PO BID on days 1-28 and cixutumumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose of selumetinib in combination with cixutumumab defined as the dose produced DLT in =< 1 out of 6 patients [ Time Frame: Up to 4 weeks ]The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals. Tabulated by dose combination, by toxicity type, and by the severity.
- Pharmacokinetics of the combination of selumetinib and cixutumumab [ Time Frame: Prior to the dose and at 0.5, 1, 1.5, 2, 4, and 8 hours ]Peak serum level (Cmax), the trough level (Cmin), and the Area Under the serum concentration time Curve (AUC) will be summarized using descriptive statistics.
- The proportion of patients who experience PR, CR, or SD as defined by RECIST criteria [ Time Frame: Up to 4 weeks after completion of study treatment ]
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): NCT01061749
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Nilofer Azad||Johns Hopkins University/Sidney Kimmel Cancer Center|