Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03047213
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 24, 2017
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT05700344 - SOGUG-AVELUMAB_RWD
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT04953104 - Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Phase 2
Withdrawn NCT06050954 - A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA) Phase 2
Active, not recruiting NCT03534804 - Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma Phase 2
Active, not recruiting NCT00365157 - Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction Phase 1/Phase 2
Withdrawn NCT06018116 - A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. Phase 2
Recruiting NCT05544552 - Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Phase 1/Phase 2
Recruiting NCT04936230 - Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Terminated NCT05052372 - Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Terminated NCT03115801 - A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers Phase 2
Active, not recruiting NCT03854474 - Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma Phase 1/Phase 2
Terminated NCT02693717 - Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer Phase 2
Recruiting NCT04848519 - Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma Phase 2
Active, not recruiting NCT04724018 - Sacituzumab Govitecan Plus EV in Metastatic UC Phase 1
Terminated NCT04003610 - Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) Phase 2
Recruiting NCT04383067 - A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients Phase 2
Not yet recruiting NCT03108261 - Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations Phase 2