Carcinoma Clinical Trial
Official title:
A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.
Patients with recurrent and/or metastatic unresectable Head and Neck Cancer have a poor prognosis and limited treatment options. Pembrolizumab and Nivolumab, both ICIs (Immune Checkpoint Inhibitors), are approved therapies for this condition. However, no approved treatment options exist for patients who progress on ICI therapies. Hence, there is an unmet medical need post-failure of ICI therapy. NRC-2694-A is an orally administered small-molecule tyrosine kinase inhibitor. It was discovered and developed by NATCO Pharma Ltd. NRC-2694-A demonstrated response in HNSCC patients in a Phase-I study as a monotherapy. This was further substantiated in a Phase-II study in combination with cisplatin/carboplatin and paclitaxel. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04362072 -
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
|
Phase 4 | |
| Completed |
NCT04033991 -
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
|
||
| Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
| Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT01942200 -
A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
|
||
| Completed |
NCT01061645 -
Study of MOC31-PE in Antigen Positive Carcinomas
|
Phase 1 | |
| Terminated |
NCT00557596 -
A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00532155 -
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT00216372 -
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
|
Phase 3 | |
| Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
| Recruiting |
NCT05752357 -
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
|
||
| Not yet recruiting |
NCT05023928 -
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
|
Phase 1 | |
| Completed |
NCT00446446 -
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
|
Phase 2 | |
| Recruiting |
NCT04566952 -
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06112041 -
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
|
Phase 2 | |
| Completed |
NCT03562897 -
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
|
Phase 2 | |
| Recruiting |
NCT06013111 -
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04600206 -
Existential Distress in Patients With Advanced Cancer and Their Caregivers
|