Spots Global Cancer Trial Database for Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
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Trial Identification
Brief Title: Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
Official Title: An Open Label, Multicenter, Single Arm Phase II Study to Evaluate the Activity and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK-228), in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Whose Tumors Harbor a TSC1 and/or a TSC2 Mutation
Study ID: NCT03047213
Interventions
Study Description
Brief Summary: This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2 mutations (changes in deoxyribonucleic acid \[DNA\]). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the overall response rate (ORR) defined as complete response (CR) and partial response (PR) in patients with locally advanced or metastatic transitional cell carcinoma (TCC) harboring a TSC1 mutation. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of sapanisertib (MLN0128) (TAK-228) in patients with locally advanced or metastatic TCC harboring a TSC1 or TSC2 mutation. II. To evaluate progression free survival (PFS) and overall survival (OS). EXPLORATORY OBJECTIVES: I. To determine the ORR in patients with locally advanced or metastatic TCC harboring a TSC2 mutation. II. To evaluate toxicity, PFS, and OS in TSC2 mutation patients. OUTLINE: Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Cycles 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 and every 6 months thereafter.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Keck Medical Center of USC Pasadena, Pasadena, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Nebraska Medicine-Bellevue, Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Joseph W Kim
Affiliation: Yale University Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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