Clinical trials: TP53 Gene Mutation
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in…
- Trial name
- NCT02797964
- Testing
- SRA737
- Where
- 15 sites in United Kingdom
- Volunteers
- 107 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Acute Myeloid Leukemia
Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia
This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia.
- Trial name
- NCT04277442
- Testing
- Decitabine, Nivolumab, Venetoclax
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Myeloid Malignancy
APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid…
- Trial name
- NCT04214860
- Testing
- APR-246, Venetoclax, Azacitidine
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Aprea Therapeutics
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
Acute Myeloid Leukemia or Myelodysplastic Syndromes
APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with…
- Trial name
- NCT03931291
- Testing
- APR-246
- Where
- 7 sites in United States
- Volunteers
- 33 people
- Sponsor
- Aprea Therapeutics
Colorectal Cancer
Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer
A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the epidermal growth factor receptor (EGFR) inhibitor, Cetuximab in patients with metastatic colorectal cancer (mCRC) harboring Adenomatous…
- Trial name
- APK Mutant (NCT04853043)
- Testing
- Cetuximab
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- University of Utah
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia in Remission
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia in Remission, Hematopoietic Cell Transplantation Recipient, JAK2 Gene Mutation
- Trial name
- NCT03272633
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Irradiated Allogeneic Cells
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Rutgers, The State University of New Jersey
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
This phase II trial studies the how well berzosertib and irinotecan work in treating patients with gastric or gastroesophageal junction cancer that is growing, spreading or getting worse (progressive), has spread to other places…
- Conditions
- Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Trial name
- NCT03641313
- Testing
- Berzosertib, Computed Tomography Assisted Biopsy, Endoscopic Biopsy
- Where
- 31 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Cancer Institute (NCI)
Cancer, Skin Fibroblasts
Nicotinamide Riboside on Mitochondrial Function in Li-Fraumeni Syndrome
Background: Nicotinamide riboside (NR) is a vitamin B3 dietary supplement. It may help improve muscle function, that may in turn may improve a person s exercise capacity.
- Conditions
- Cancer, Skin Fibroblasts, Muscle Weakness
- Trial name
- NCT03789175
- Testing
- Nicotinamide Riboside (NR)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Chronic Lymphocytic Leukemia
A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment…
- Trial name
- VENICE I (NCT02756611)
- Testing
- Venetoclax
- Where
- 67 sites in United States, Austria and 19 more
- Volunteers
- 258 people
- Sponsor
- AbbVie
MDS
APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
- Trial name
- NCT03745716
- Testing
- APR-246 + azacitidine, Azacitidine
- Where
- 27 sites in United States, France
- Volunteers
- 154 people
- Sponsor
- Aprea Therapeutics
Acute Myeloid Leukemia
Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53…
- Trial name
- ENHANCE-2 (NCT04778397)
- Testing
- Magrolimab, Venetoclax, Azacitidine
- Where
- 156 sites in United States, Australia and 13 more
- Volunteers
- 258 people
- Sponsor
- Gilead Sciences
Cancer
Study of SNX-5422 in TP53 Null Cancers
SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90).
- Trial name
- NCT02612285
- Testing
- SNX-5422
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Esanex Inc.
Myelodysplastic Syndrome, Acute Myeloid Leukemia
Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms
The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival.
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Chronic Myelomonocytic Leukemia
- Trial name
- NCT03072043
- Testing
- APR-246, Azacitidine
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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
Chronic Lymphocytic Leukemia (CLL)
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a…
- Trial name
- CRISTALLO (NCT04285567)
- Testing
- Obinutuzumab, Venetoclax, Fludarabine
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 166 people
- Sponsor
- Hoffmann-La Roche
Acute Myeloid Leukemia, Acute Myeloid Leukemia, Relapsed, Adult
Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
In this study, the investigators seek to determine whether decitabine therapy can improve outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML) patients with the poorest prognosis based on…
- Trial name
- NCT03063203
- Testing
- Decitabine, Bone marrow biopsy/aspirate, Peripheral blood draw
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Washington University School of Medicine
Chronic Lymphocytic Leukemia (CLL)
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of…
- Trial name
- VENICE II (NCT02980731)
- Testing
- Venetoclax
- Where
- 33 sites in Argentina, Australia and 8 more
- Volunteers
- 210 people
- Sponsor
- AbbVie
Large-Cell Neuroendocrine Carcinoma
Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC).
- Trial name
- PRECISION-NEC (NCT04452292)
- Testing
- Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma, Treatment for Small Cell Lung Cancer
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Charles Kunos
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