Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors
|ClinicalTrials.gov Identifier: NCT01639911|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast CNS Malignancy Malignant Neoplasm of Gastrointestinal Tract Genitourinary Neoplasms Malignancy and Gender Unspecified Head and Neck Neoplasms Melanoma Malignant Neoplasm of Thorax||Drug: Alisertib Drug: Pazopanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||STM-01: Phase I EffTox Study of Aurora A Kinase Inhibitor Alisertib (MLN8237) Given in Combination With Selective VEGFR Inhibitor Pazopanib (Votrient) for Therapy of Solid Tumors|
|Actual Study Start Date :||August 14, 2013|
|Actual Primary Completion Date :||July 28, 2016|
|Actual Study Completion Date :||July 28, 2016|
Experimental: Treated Patients with Solid Tumor
Patients will receive alisertib orally twice a day for the first 7 days of a 21 day cycle. Patients will also receive pazopanib orally once a day continuously. Treatment continues until disease progression, unacceptable toxicity or patient refusal. The study consists of two components which are the dose finding component and optimally tolerated dose extension with pharmacokinetics component.
Alisertib at the assigned dose by mouth (PO) twice a day for 7 days beginning on day 1 of a 21 day cycle.
Other Name: MLN8237Drug: Pazopanib
Pazopanib at the assigned dose once a day continuously for the duration of treatment.
Other Name: Votrient
- Optimally Tolerated Dose [ Time Frame: At end of Cycle 1 (approximately Day 21) ]Complete all planned treatment for cycle 1 (defined as 14 doses of alisertib and daily pazopanib) without dose limiting toxicity and are able to start cycle 2 with no more than a 2 week delay.
- Toxicity Profile [ Time Frame: Within 30 days of Last Treatment Dose ]Adverse events which occur after taking at least one dose of study treatment with either alisertib and/or pazopanib.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639911
|United States, Illinois|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Arkadiusz Z. Dudek, M.D.||University of Illinois at Chicago|