Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

ABSTRACT: This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).

DISEASE(S): Myeloproliferative Neoplasms,Solid Tumor,Hematologic Neoplasms,Solid Tumors And Hematologic Malignancy,Leukemia,Non-small Cell Lung Cancer,Colorectal Cancer,Lymphoma,Breast Cancer,Neoplasms

PROVIDER: 2189028 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Project description:The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

| 2210462 | ecrin-mdr-crc

Early Onset Malignancies Initiative

Project description:Early Onset Malignancies Initiative

| PRJNA597501 | ENA

Early Onset Malignancies Initiative

Project description:Early Onset Malignancies Initiative

| PRJNA597502 | ENA

A Clinical Urine Metabolomics Dataset for Urological Malignancies

Project description:Renal cell carcinoma, bladder cancer, and prostate cancer rank among the most common urological malignancies, yet clinically satisfactory non-invasive screening tools for these cancers are still lacking. Here we present an untargeted urine metabolomics dataset generated by liquid chromatography coupled with high-resolution mass spectrometry from 368 clinical urine samples, comprising 249 patients with urological malignancies (194 renal cancer, 39 bladder cancer, and 16 prostate cancer), 62 patients with benign renal , and 57 healthy controls. Clear cell renal cell carcinoma (ccRCC) was the dominant histological subtype in the renal cancer subgroup (170 cases, 87.6%). Chromatographic separation was carried out on an ACQUITY UPLC I-Class system, and detection was performed on a Q Exactive Orbitrap high-resolution mass spectrometer in both positive and negative electrospray ionization modes. Raw data were processed through peak detection, baseline correction, alignment, annotation, and a multi-step normalization pipeline, yielding a final set of 472 metabolic features common to all three groups. The full dataset, along with clinical metadata, data processing scripts, and heatmap visualization code, has been deposited on figshare to support urinary biomarker discovery, diagnostic modeling, and metabolic pathway investigation in urological oncology.

2026-06-27 | MTBLS14865 | MetaboLights

Proteomic characterization of cerebrospinal fluid in patients with brain malignancies

Project description:Recent technological advances in molecular diagnostics through liquid biopsies hold the promise to monitor tumor evolution and treatment response of brain malignancies without the need of invasive surgical tissue accrual. Here, we implemented a new mass spectrometry-based protein analysis pipeline and analyzed 251 cerebrospinal fluid (CSF) samples from patients with four types of brain malignancies (glioblastoma, lymphoma, brain metastasis and meningeal disease) as well as from healthy individuals. On average, we identified 511 ± 121 proteins per CSF sample. 169 proteins were commonly deregulated in all four types of brain malignancies compared to controls. CSF analysis of glioblastoma patients identified two proteomic clusters that correlated with tumor size and patient survival. By integrating CSF data with proteomic analyses of matching glioma tumor tissue and primary glioma cells, we identified potential CSF biomarkers for glioblastoma, in particular chitinase-3-like protein 1 (CHI3L1) and glial fibrillary acidic protein (GFAP). Results were validated in a prospective cohort with 35 glioblastoma patients. Response of a patient with meningeal disease to combinatorial drug treatment was associated with a complex shift of the proteomic signature, including detection of potential drug resistance mechanisms. Therefore, proteomic analysis of CSF in brain malignancies has the potential to reveal biomarkers for diagnosis and therapy monitoring.

2021-03-25 | PXD021984 | Pride

Dual BCL-xL and BCL-2 Inhibition for Advanced Myeloid Neoplasms: A phase 1 dose-escalation study of Navitoclax, Venetoclax, and Decitabine

Project description:Background: The BCL-2 inhibitor venetoclax in combination with a hypomethylating agent is effective against most acute myeloid leukemia (AML) subtypes, but less so against other high-risk myeloid neoplasms. One resistance mechanism to BCL-2 inhibition is increased dependence on alternate BH3-only anti-apoptotic proteins, such as BCL-xL. Navitoclax is a BCL-2/BCL-xL inhibitor that has been previously studied in hematologic malignancies. Patients and methods: We conducted a Phase 1 study of dose-escalated navitoclax added to venetoclax/decitabine for subjects with 1) secondary (s-AML) or therapy-related AML, 2) accelerated- or blast-phase myelofibrosis (AP/BP-MF), 3) myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) overlap syndromes with excess blasts, or 4) relapsed/refractory (R/R) MDS with excess blasts. Results:Sixteen subjects were enrolled. Dose-escalation for BP-MF and s-AML was not completed due to discontinued navitoclax supply. Most common grade ≥3 treatment-emergent adverse events included neutropenia (69%), thrombocytopenia (69%), and febrile neutropenia (47%). No clinically significant bleeding was observed. One dose-limiting toxicity of delayed neutrophil recovery occurred. Among 15 evaluable subjects, the overall objective response rate was 60% (9/15). The recommended phase 2 dose was decitabine 20 mg/m2 days 1-5, venetoclax 400 mg/day days 1-14, and navitoclax 50 mg/day days 1-14 for AP-MF, MDS/MPN, and R/R MDS. Correlative studies indicate preserved immature platelet fractions despite on-target reduction of mature platelets, a reduction in disease-associated aberrant monocytes in subjects with monocytic disease, and higher baseline myeloblast dependence on BCL-2 and BCL-xL as predictive of response. Conclusion:Navitoclax added to venetoclax/decitabine is safely tolerable and is active in patients with high-risk myeloid malignancies.

2026-04-20 | GSE312447 | GEO

A phase 1 study of the CDK9 inhibitor voruciclib in relapsed/refractory acute myeloid leukemia and B-cell malignancies

Project description:The anti-apoptotic protein myeloid cell leukemia-1 (Mcl-1) contributes to the pathophysiology of acute myeloid leukemia (AML) and certain B-cell malignancies. Dependence on Mcl-1 is associated with resistance to venetoclax. Voruciclib, an oral cyclin-dependent kinase (CDK) inhibitor targeting CDK9, indirectly decreases Mcl-1 protein expression and synergizes with venetoclax in preclinical models. This dose escalation study evaluated voruciclib in patients with previously treated hematologic malignancies (registered as NCT03547115). Initially, voruciclib was administered daily continuously on a 28-day cycle (Group I). After two patients with prior allogeneic stem cell transplantation had a dose limiting toxicity (DLT) of interstitial pneumonitis at 100 mg, voruciclib administration was changed to days 1-14 of a 28-day cycle (Group II). Forty patients, 21 with AML and 19 with B-cell malignancies, were enrolled. Patients had a median of 3 prior lines of therapyies (range, 1-8). Dose escalation in Group II was stopped at 200 mg, a dose that achieved plasma concentrations sufficient for target inhibition, without DLTs observed. The most common adverse events were diarrhea (30%), nausea (25%), anemia (22%), fatigue (22%), constipation (17%), dizziness (15%) and dyspnea (15%). In AML, one patient achieved a morphologic leukemia-free state and two had stable disease. There was a Voruciclib treatment led to a decrease in MCL1 mRNA expression, downregulation of MYC and NF-κB transcriptional gene sets, and reduced phosphorylation of RNA polymerase II . Voruciclib on intermittent dosing was well tolerated, with no DLTs, paving the way for evaluation of the combination of voruciclib with venetoclax in patients with previously treated AML.

2025-11-04 | GSE281161 | GEO

MGH Gastrointestinal Malignancies Resistance Initiative

Project description:MGH Gastrointestinal Malignancies Resistance Initiative

| PRJNA550215 | ENA

MGH Gastrointestinal Malignancies Resistance Initiative

Project description:MGH Gastrointestinal Malignancies Resistance Initiative

| PRJNA550216 | ENA

Antibiotics treatment ameliorates TET2 loss-of-function associated hematological malignancies

Project description:Antibiotics treatment ameliorates TET2 loss-of-function associated hematological malignancies

| PRJNA533092 | ENA