Clinical trials: p53 Mutations
Astrocytoma, Glioblastoma
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance imaging (MRI).
- Conditions
- Astrocytoma, Glioblastoma, Glioma
- Trial name
- NCT00001148
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Li-Fraumeni Syndrome, Hereditary Cancer Syndromes
Biomarker Monitoring in TP53 Mutation Carriers
Purpose This study is an 'N-of-one' observational study focusing on individuals with a hereditary predisposition to cancer due to a genetic mutation in the TP53 gene.
- Conditions
- Li-Fraumeni Syndrome, Hereditary Cancer Syndromes, TP53 Gene Germline Mutation Carrier
- Trial name
- NCT02289326
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Scripps Health
Lymphadenectomy, Endometrial Cancer
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations.
- Conditions
- Lymphadenectomy, Endometrial Cancer, Gene, p53, Sentinel Lymph Node Biopsy (SLNB)
- Trial name
- SENTIMETREP53 (NCT06900582)
- Testing
- Sentinel Lymph Node Mapping, Comprehensive pelvic and para-aortic lymphadenectomy
- Volunteers
- 374 people
- Sponsor
- University Hospital, Strasbourg, France
Colorectal Cancer Metastatic, Colorectal Cancer Stage IV
The p53 Colorectal Cancer Trial
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e.
- Conditions
- Colorectal Cancer Metastatic, Colorectal Cancer Stage IV, TP53 Gene Mutation
- Trial name
- NCT03149679
- Testing
- Cyclophosphamide
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Haukeland University Hospital
Mitochondrial Disorders, Li-Fraumeni Syndrome
Role of p53 Gene in Metabolism Regulation in Patients With Li-Fraumeni Syndrome
This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome, a rare hereditary disorder that greatly increases a person's susceptibility to cancer.
- Conditions
- Mitochondrial Disorders, Li-Fraumeni Syndrome, Carriers of p53 Mutation
- Trial name
- NCT00406445
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Colorectal Cancer, APC Gene Mutation
Patogenic Mutation in 5 Genes
This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.
- Conditions
- Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation, PIK3CA Gene Mutation
- Trial name
- NCT04976439
- Testing
- co-occuring mutation
- Where
- Indonesia
- Volunteers
- 22 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Education
Transition From Research to Disclosure in Human Genetics
The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations…
- Trial name
- NCT00505466
- Testing
- Genetic Counseling
- Where
- United States
- Volunteers
- 577 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
P53 Mutation, Myeloid Malignancy
Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS
TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established.
- Conditions
- P53 Mutation, Myeloid Malignancy, MDS, Aml
- Trial name
- PANDA-T0 (NCT03855371)
- Testing
- Decitabine, Arsenic Trioxide
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Ruijin Hospital
P53 Mutation in Esophageal Cancer
ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death…
- Trial name
- NCT07722819
- Testing
- No intervention
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Ling Zhiqiang
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
Advanced Solid Tumor, Unresectable Solid Tumor
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Colorectal Adenocarcinoma
- Trial name
- GUARDIAN-101 (NCT06778863)
- Testing
- CLSP-1025
- Where
- 21 sites in United States
- Volunteers
- 90 people
- Sponsor
- Clasp Therapeutics, Inc.
Adult Solid Neoplasm, Bladder Carcinoma
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that…
- Conditions
- Adult Solid Neoplasm, Bladder Carcinoma, Colon Carcinoma, Estrogen Receptor Negative
- Trial name
- NCT02432963
- Testing
- Laboratory Biomarker Analysis, Modified Vaccinia Virus Ankara Vaccine Expressing p53, Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
CLL
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in 17p- Chronic Lymphocytic Leukemia (CLL)
17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome after chemoimmunotherapy.
- Trial name
- 17p-CLL (NCT01675102)
- Where
- 10 sites in Denmark, Finland and 5 more
- Volunteers
- 41 people
- Sponsor
- European Society for Blood and Marrow Transplantation
Acute Myeloid Leukemia, TP53 Gene Mutation
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
- Trial name
- NCT07511062
- Testing
- Decitabine, Venetoclax, Axatilimab
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Northside Hospital, Inc.
Ovarian Cancer
A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation.
- Trial name
- NCT01357161
- Testing
- adavosertib, paclitaxel, carboplatin
- Volunteers
- 136 people
- Sponsor
- Merck Sharp & Dohme LLC
Ovarian Cancer, Endometrial Cancer
Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation
This study is a Single-center, open, single-arm and non-randomized clinical trial in China. The aim of this study is to evaluate the efficacy, safety, and tolerability of Arsenic trioxide for injection in patients with recurrent…
- Trial name
- NCT04489706
- Testing
- Arsenic trioxide for injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ruijin Hospital
Advanced Solid Tumors
Study of AMG 650 in Adult Participants With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04293094
- Testing
- AMG 650
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 66 people
- Sponsor
- Volastra Therapeutics, Inc.
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD.
- Trial name
- NCT02272790
- Testing
- Adavosertib, Paclitaxel, Carboplatin
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 95 people
- Sponsor
- AstraZeneca
Ovarian Cancer, Breast Cancer
A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer
Background: All cells go through cycles which allow them to divide. In normal cells, checkpoint kinase 1 (Chk1) and checkpoint kinase 2 (Chk2) (CHEK 2 (Chk1/2) stop cell division at various points to allow any damage to…
- Conditions
- Ovarian Cancer, Breast Cancer, Prostate Cancer
- Trial name
- NCT02203513
- Testing
- LY2606368
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- National Cancer Institute (NCI)
Locally Advanced Breast Cancer, Metastatic Breast Carcinoma
The p53 Breast Cancer Trial
This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified to one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs.
- Trial name
- p53b (NCT02965950)
- Testing
- Cyclophosphamide
- Where
- 5 sites in Norway
- Volunteers
- 190 people
- Sponsor
- Haukeland University Hospital