MLN8237 and Pazopanib in Combination for Solid Tumors
This phase I dose escalation study will evaluate alisertib, an Aurora A kinase inhibitor, when given in combination with the selective vascular endothelial growth factor receptor (VEGFR) inhibitor pazopanib in patients with advanced, previously treated non-hematologic solid tumors.
Malignant Neoplasm of Breast
Malignant Neoplasm of Gastrointestinal Tract
Genitourinary Neoplasms Malignancy and Gender Unspecified
Head and Neck Neoplasms
Malignant Neoplasm of Thorax
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Aurora A Kinase Inhibitor (MLN8237) Given in Combination With Selective VEGFR Inhibitor Pazopanib (Votrient) for Therapy in Solid Tumors|
- Optimally Tolerated Dose [ Time Frame: At end of Cycle 1 (approximately Day 21) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Adverse events which occur after taking at least one dose of study treatment with either alisertib and/or pazopanib.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Treated Patients with Solid Tumor
Alisertib at the assigned dose (10, 20, 40 or 50 mg) by mouth PO twice a day for 7 days beginning on day 1 of a 21 day cycle. Pazopanib at the assigned dose (400, 600 or 800 mg) by mouth (PO) once a day beginning on day 10 of the 1st cycle and continuing daily for the duration of study treatment.
Alisertib at the assigned (10, 20, 40 or 50 mg) 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 (400, 600 or 800 mg) by mouth (PO) once a day beginning on day 10 of the 1st cycle and continuing daily for the duration of study treatment.
Other Name: Votrient
Alisertib is taken orally twice a day for the 1st 7 days of a 21 day cycle. Pazopanib is taken orally once a day continuously beginning on day 10 of cycle 1 to allow for alisertib pharmacokinetics (PKs). Treatment continues until disease progression, unacceptable toxicity, or patient refusal. PKs will be done on all patients in association with the last dose of alisertib cycles 1 and 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639911
|Contact: Arkadiusz Z. Dudek, M.D.||firstname.lastname@example.org|
|United States, Illinois|
|University of Illinois Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Arkadiusz Z. Dudek, M.D. 312-413-8878 email@example.com|
|Contact: Williams Alisha, RN (312) 413-2746 firstname.lastname@example.org|
|Principal Investigator: Arkadiusz Z. Dudek, M.D.|
|Principal Investigator:||Arkadiusz Z. Dudek, M.D.||University of Illinois at Chicago|