In short
Clinical trials investigating ANHYDROUS CALCIUM FOLINATE are studying how it is used in different patient groups, including cancer and rare mitochondrial disease. These studies look at safety, treatment response, and other outcomes such as survival or disease scores. The trials include adults with advanced cancers and patients with Kearns-Sayre syndrome.
Key points
- Clinical trials of ANHYDROUS CALCIUM FOLINATE are being done in both cancer and rare disease settings. In cancer studies, it appears in treatment plans for colorectal cancer, gastric cancer, esophageal carcinoma, and pancreatic adenocarcinoma. One Phase 2 study looks at Kearns-Sayre syndrome and cerebral folate deficiency in a small group of patients. The trials range from Phase 1 to Phase 3, so they include early safety work and larger studies of treatment benefit. Main outcomes include response rate, survival, surgery results, and disease scores. The studies are authorised or completed, with patient groups chosen for each specific condition.
Trials overview
These clinical trials study ANHYDROUS CALCIUM FOLINATE as part of different treatment plans in cancer and one rare genetic condition. The studies are interventional, which means researchers give a treatment and then measure what happens. The listed trials include authorised and completed studies.
Cancer studies
Several trials include ANHYDROUS CALCIUM FOLINATE in treatment plans for advanced or metastatic colorectal cancer, metastatic gastric adenocarcinoma, esophageal carcinoma, and pancreatic adenocarcinoma. These studies test ANHYDROUS CALCIUM FOLINATE together with other medicines, so the research is about the full treatment plan rather than this substance alone.
The colorectal cancer study is a Phase 1b/2 open-label trial, meaning both doctors and patients know which treatment is given, and the study has an early safety part and a later treatment-testing part. It includes monotherapy and combination treatment groups, and its main cancer outcome is objective response rate, which shows how many tumours shrink or disappear.
The gastric cancer study is a randomized Phase 2 trial in people with PD-L1 CPS ≥5 metastatic gastric cancer. Its main goal is to measure objective response rate at 4 months for the experimental treatment plan that includes ANHYDROUS CALCIUM FOLINATE as part of FOLFOX.
The esophageal carcinoma study is a large Phase 3 trial with 877 participants. It first checks safety and tolerability in a run-in part, then compares overall survival between treatment arms in the main study.
The pancreatic adenocarcinoma study is a randomized Phase 2 trial in borderline resectable disease, which means the tumour may be difficult to remove fully at first but could become operable after treatment. The main goals are R0 resection, meaning no visible cancer is left at the surgery edge, and disease-free survival.
Rare disease study
One Phase 2 trial studies ANHYDROUS CALCIUM FOLINATE in patients with Kearns-Sayre syndrome and cerebral folate deficiency. This study compares folinic acid treatment with no treatment to see whether symptoms and clinical outcome improve. The trial is small, with 18 participants, which is common in rare disease research.
The main measurement in this study is the International Pediatric Mitochondrial Disease Scale, or IPMDS, which is a score used to track disease severity over time. The scale is checked at several time points from baseline to month 18, and the main comparison is the difference after 6 months between the treatment group and the no-treatment group.
Phases and study status
The trials cover Phase 1, Phase 2, and Phase 3 research, so they include early testing, mid-stage testing, and large confirmatory research. The Phase 1 study in colorectal cancer focuses on dose confirmation and safety in combination treatment. The Phase 2 studies look at treatment activity and safety, while the Phase 3 study compares survival in a larger group.
All listed trials are either authorised or completed. This means some studies may still be open, while one has already finished.
Main outcomes being measured
The trials measure different outcomes depending on the condition being studied. In cancer studies, important outcomes include objective response rate, overall survival, disease-free survival, and whether surgery can remove all visible tumour tissue.
Safety is also a major part of the research. The studies track dose limiting toxicities, adverse events, and treatment stopping because of side effects in the Phase 3 esophageal trial and the Phase 1 colorectal trial.
In the Kearns-Sayre syndrome trial, the main outcome is the IPMDS score over time, with repeated measurements at baseline and during follow-up. This helps researchers see whether the treatment changes the course of the disease.
Who may participate
Each study has a different target group, based on the disease being studied. The cancer trials focus on adults with advanced or metastatic disease, while the rare disease trial focuses on patients with Kearns-Sayre syndrome.
- Advanced or metastatic colorectal cancer: patients are studied to see whether the treatment plan can control tumour growth and improve response.
- Metastatic gastric adenocarcinoma: patients with advanced stomach cancer are studied in a randomized Phase 2 design.
- Metastatic esophageal carcinoma: a larger Phase 3 group is used to compare survival outcomes.
- Borderline resectable pancreatic adenocarcinoma: patients are studied before surgery to see whether treatment can make tumour removal more successful.
- Kearns-Sayre syndrome: patients with this rare condition are studied to see whether folinic acid treatment improves clinical scores.
Key points for patients
ANHYDROUS CALCIUM FOLINATE appears in trials across very different diseases, so its role depends on the study question. In cancer, the research is mainly about treatment response, survival, and surgery results. In the rare disease study, the focus is on symptom and disease-score changes over time.