Gastrointestinal Cancer Clinical Trial
Official title:
A Phase 2 Basket Trial of Ulixertinib (BVD-523) in Combination With Hydroxychloroquine in Patients With Advanced GI Malignancies Harboring Mitogen-activated Protein Kinase (MAPK) Pathway Mutations (BVD-523-HCQ)
This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring rat sarcoma virus (RAS), a member of the rapidly accelerated fibrosarcoma (non-V600 BRAF), extracellular signal-regulated kinase (ERK), or mitogen-activated protein kinase (MEK) mutations. The trial will have five baskets based on disease primary as listed below. Basket 1: Cholangiocarcinoma including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma; Basket 2: Pancreatic adenocarcinoma; Basket 3: Colorectal adenocarcinoma; Basket 4: Esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastroesophageal junction (GEJ) adenocarcinoma; Basket 5: Gastric adenocarcinoma. While the overall trial is a basket design, each basket will operate as a Simon two-stage design and therefore, will open to enrollment in two-stages. Total enrollment for Stage 1 is targeted at approximately 65 patients with 13 patients per group. Additional patients may be enrolled as appropriate. Total enrollment for Stage 2 is targeted to approximately 150 patients with up to 30 patients per group. Additional patients may be enrolled as appropriate. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Not yet recruiting |
NCT05044312 -
Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis
|
N/A | |
Active, not recruiting |
NCT05053191 -
Advancing Nursing Practices in Hospital Oncology Care
|
N/A | |
Completed |
NCT03611309 -
Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members
|
N/A | |
Recruiting |
NCT03602677 -
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
|
N/A | |
Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06398314 -
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
|
N/A | |
Withdrawn |
NCT04030624 -
Remote Electronic Patient Monitoring in Gastrointestinal Cancer
|
N/A | |
Completed |
NCT02140593 -
The Laparotomy Study
|
Phase 4 | |
Completed |
NCT02222259 -
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
|
N/A | |
Active, not recruiting |
NCT00716209 -
Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers
|
N/A | |
Recruiting |
NCT01484444 -
Biomarker Analysis of Gastrointestinal Cancer
|
N/A | |
Completed |
NCT02130427 -
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
|
N/A | |
Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
Completed |
NCT00094965 -
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
|
Phase 2 | |
Terminated |
NCT04077372 -
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
|
N/A | |
Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
Recruiting |
NCT05429866 -
Immunological Variables Associated to ICI Toxicity in Cancer Patients
|
Phase 2 | |
Recruiting |
NCT05226221 -
Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
|
||
Recruiting |
NCT03286348 -
Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer
|
N/A |