(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
NCT03837821 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-11-18
Summary
Single-arm, open-label window-of-opportunity trial of neoadjuvant Abemaciclib in 20 patients, with tumor tissue obtained as standard of care at tumor resection (pre-Abemaciclib) and cystectomy (post-Abemaciclib)
Conditions
Interventions
- DRUG
-
Abemaciclib 200 mg oral, every 12 hours
Sponsors & Collaborators
- collaborator INDUSTRY
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Bishoy Faltas, MD · Weill Medical College of Cornell University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-05
- Primary Completion
- 2024-07-02
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma
NCT02969083 ·Status: RECRUITING ·Phase: PHASE2
-
A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer
NCT03498196 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
NCT05687721 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma
NCT03658304 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy
NCT04579133 ·Status: TERMINATED ·Phase: PHASE2
-
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
NCT06237920 ·Status: RECRUITING ·Phase: PHASE2
-
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
NCT04876313 ·Status: UNKNOWN ·Phase: PHASE2
-
Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer
NCT03171025 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
NCT04617756 ·Status: RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Bladder Cancer
NCT00003701 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy
NCT05366725 ·Status: COMPLETED
-
Dose Dense MVAC for Muscle Invasive Bladder Cancer
NCT01031420 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
NCT02178241 ·Status: COMPLETED ·Phase: PHASE2
-
Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy
NCT03387761 ·Status: COMPLETED ·Phase: PHASE1
-
Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma
NCT02788201 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
NCT02853305 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
NCT00461851 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
NCT00028756 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
NCT04209114 ·Status: COMPLETED ·Phase: PHASE3
-
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
NCT00749892 ·Status: COMPLETED ·Phase: PHASE2
-
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
NCT04878029 ·Status: RECRUITING ·Phase: PHASE1
-
CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
NCT03628716 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
NCT03785925 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
NCT00003129 ·Status: COMPLETED ·Phase: PHASE2
-
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
NCT03617913 ·Status: COMPLETED ·Phase: PHASE2