Urologic Neoplasms Clinical Trial
Official title:
LUX-Bladder 1: Phase II Open Label Single Arm Exploratory Trial of Oral Afatinib Monotherapy Following Platinum Failure for Patients With Advanced/Metastatic Urothelial Tract Carcinoma With Genetic Alterations in ERBB Receptors.
The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis. The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00151034 -
Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer
|
Phase 2 | |
Completed |
NCT04933604 -
LPN in Patients With High-complex Renal Tumors
|
||
Completed |
NCT03219333 -
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
|
Phase 2 | |
Completed |
NCT04052113 -
Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
|
||
Terminated |
NCT02543645 -
A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT01454089 -
A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03288545 -
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05025930 -
Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
|
N/A | |
Not yet recruiting |
NCT05135520 -
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
|
N/A | |
Withdrawn |
NCT04630483 -
Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery
|
||
Terminated |
NCT02386111 -
A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03081858 -
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04644432 -
Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT05308771 -
To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
|
N/A | |
Terminated |
NCT00226954 -
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
|
Phase 2 | |
Completed |
NCT05113134 -
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen
|
N/A | |
Completed |
NCT04213157 -
Laparoscopic Partial Nephrectomy for cT1 Tumors
|
||
Recruiting |
NCT04922047 -
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06353906 -
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
|
Phase 2 | |
Recruiting |
NCT05935748 -
Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
|
Phase 2 |