Metastatic Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
A Phase 1/2 Study of Olaparib in Combination With Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)
This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be removed by surgery (unresectable). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer compared to ramucirumab and paclitaxel (a chemotherapy drug) or ramucirumab alone.
PRIMARY OBJECTIVES: I. To determine the safe dose of olaparib with ramucirumab, but not to exceed olaparib dose of 300 mg twice daily (tablet formulation). (Phase I) II. To determine the efficacy of olaparib plus ramucirumab as measured by the objective response rates (ORR) stratified by BROCA-HR biomarker status. (Phase II). SECONDARY OBJECTIVES: I. To estimate median progression-free survival (PFS) stratified by BROCA-HR biomarker status. II. To estimate median overall survival (OS) stratified by BROCA-HR biomarker status. III. To measure the prevalence of the BROCA-HR biomarker in our study population. IV. To determine toxicity of olaparib and ramucirumab combination. EXPLORATORY OBJECTIVES: I. To assess the correlation between the signature 3 status, and mutations in BROCA-HR panel. II. To evaluate the association between findings from BROCA-HR panel with response to therapy. III. To evaluate the association between findings from BROCA-HR panel and signature 3 results with response to therapy. IV. To determine results of immunoassay for poly-ADP-ribosylated (PAR) substrates in tumor tissue. V. To create a PDX model to study deoxyribonucleic acid (DNA) repair in gastric tumors treated with PARP inhibitors (PARPi) from both pre-treatment biopsy and repeat biopsy after 16 weeks of treatment. VI. Development of a novel genomic assay for BRCAness. VII. Defining T cell receptor diversity of gastric cancer patients +/- BRCAness. VIII. Biobank additional tumor tissue for future genomic analysis. IX. Biobank peripheral blood for future genomic analysis and assessment of circulating tumor DNA. OUTLINE: This is a phase I, dose-escalation study of olaparib followed by a phase II study. Patients receive olaparib orally (PO) twice daily (BID) on days 1-14 of each cycle and ramucirumab intravenously (IV) over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 6 weeks thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01142388 -
Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03337087 -
Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03641313 -
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Recruiting |
NCT04781686 -
Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05342389 -
Camrelizumab Combined With Apatinib Versus Apatinib Alone in the Third-line Treatment of Metastatic Gastric Cancer
|
Phase 2 | |
| Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05651594 -
Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT05269381 -
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04511039 -
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT04921904 -
Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04660760 -
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06203600 -
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, The PARAMMUNE Trial
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05555251 -
BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04840264 -
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
|
Phase 2 | |
| Recruiting |
NCT05677490 -
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
|
Phase 3 | |
| Completed |
NCT02391038 -
MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C
|
Phase 1/Phase 2 | |
| Completed |
NCT03395847 -
Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Adenocarcinoma
|
Early Phase 1 | |
| Recruiting |
NCT06329973 -
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05041153 -
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
|
Early Phase 1 | |
| Recruiting |
NCT04007744 -
Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors
|
Phase 1 |