NCT06487221 Avutometinib and Defactinib in Diffuse Gastric Cancer
| NCT ID | NCT06487221 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ryan H. Moy, MD, PhD |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2028-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.
Eligibility Criteria
Inclusion Criteria: 1. Histologic or cytologic evidence of gastric/gastroesophageal junction carcinoma, classified as diffuse type, poorly cohesive, signet ring cell, or mixed type. Patients with known pathogenic CDH1 and/or RHOA mutations will be allowed regardless of histology. 2. Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine. 3. ECOG performance status of 0 or 1 4. Age ≥ 18 years 5. Adequate organ function, defined by the following laboratory parameters: a. Adequate hematologic function, including hemoglobin \[Hb\] ≥ 9.0 g/dL; platelets ≥ 100,000/mm3; and absolute neutrophil count \[ANC\] ≥ 1500/mm3. If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the Hb must remain stable and ≥ 9 g/dL for at least 1 week prior to first dose of study intervention. (i) Subjects with Hgb ≥ 8.5 g/dL and \<9.0 g/dL are eligible if there is no history of significant cardiovasc
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