Irinotecan and Alisertib in Treating Patients With Advanced Solid Tumors or Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01923337|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2013
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mucinous Adenocarcinoma of the Colon Mucinous Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Signet Ring Adenocarcinoma of the Colon Signet Ring Adenocarcinoma of the Rectum Stage IIIA Colon Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: alisertib||Phase 1|
I. To investigate the feasibility and safety of MLN8237 (alisertib) when given in combination with irinotecan (irinotecan hydrochloride) to patients with advanced solid tumors.
I. To determine the maximum tolerated dose (MTD) of MLN8237 when given in combination with irinotecan to patients with advanced solid tumors and to recommend a phase II dose for the combination.
II. To obtain preliminary evidence of efficacy for this combination. III. To compare the pharmacokinetics of SN-38 (the active metabolite of irinotecan) with and without concurrent administration of MLN8237 in an expanded cohort of patients with advanced colorectal cancer.
OUTLINE: This is a dose-escalation study of alisertib.
Patients receive irinotecan hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and alisertib orally (PO) twice daily (BID) on days 1-3 and 8-10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of the Combination of Irinotecan and MLN8237 in Advanced Solid Tumors With Emphasis on Colorectal Cancer|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Treatment (irinotecan, alisertib)
Patients receive irinotecan hydrochloride IV over 30 minutes on days 1 and 8 and alisertib PO BID on days 1-3 and 8-10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: irinotecan hydrochloride
Other Names:Drug: alisertib
- MTD, defined as the highest dose tested in which fewer than 33% of patients experience dose-limiting toxicity (DLT) attributable to the study drugs, graded using the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to day 21 ]
- Incidence of toxicities observed at each dose level graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ]Will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by grade and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility of outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
- Response rates, as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 30 days ]
- Survival [ Time Frame: Up to 30 days ]Summarized with Kaplan-Meier plots.
- Time to failure [ Time Frame: Up to 30 days ]Summarized with Kaplan-Meier plots.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923337
|United States, California|
|UC Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Thomas Semrad||UC Davis Comprehensive Cancer Center|