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ANHYDROUS CALCIUM FOLINATE

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.

Table of contents

Trials overview

These clinical trials study ANHYDROUS CALCIUM FOLINATE as part of different treatment plans in cancer and one rare genetic condition.[1][2][3][4][5] The studies are interventional, which means researchers give a treatment and then measure what happens.[1][2][3][4][5] The listed trials include authorised and completed studies.[1][2][3][4][5]

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.[1][2][4][5] These studies test ANHYDROUS CALCIUM FOLINATE together with other medicines, so the research is about the full treatment plan rather than this substance alone.[1][2][4][5]

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.[1] It includes monotherapy and combination treatment groups, and its main cancer outcome is objective response rate, which shows how many tumours shrink or disappear.[1]

The gastric cancer study is a randomized Phase 2 trial in people with PD-L1 CPS ≥5 metastatic gastric cancer.[2] 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.[2]

The esophageal carcinoma study is a large Phase 3 trial with 877 participants.[4] It first checks safety and tolerability in a run-in part, then compares overall survival between treatment arms in the main study.[4]

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.[5] The main goals are R0 resection, meaning no visible cancer is left at the surgery edge, and disease-free survival.[5]

Rare disease study

One Phase 2 trial studies ANHYDROUS CALCIUM FOLINATE in patients with Kearns-Sayre syndrome and cerebral folate deficiency.[3] This study compares folinic acid treatment with no treatment to see whether symptoms and clinical outcome improve.[3] The trial is small, with 18 participants, which is common in rare disease research.[3]

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.[3] 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.[3]

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.[1][2][3][4][5] The Phase 1 study in colorectal cancer focuses on dose confirmation and safety in combination treatment.[1] The Phase 2 studies look at treatment activity and safety, while the Phase 3 study compares survival in a larger group.[2][3][4][5]

All listed trials are either authorised or completed.[1][2][3][4][5] This means some studies may still be open, while one has already finished.[1][2][3][4][5]

Main outcomes being measured

The trials measure different outcomes depending on the condition being studied.[1][2][3][4][5] In cancer studies, important outcomes include objective response rate, overall survival, disease-free survival, and whether surgery can remove all visible tumour tissue.[1][2][4][5]

Safety is also a major part of the research.[1][4] 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.[1][4]

In the Kearns-Sayre syndrome trial, the main outcome is the IPMDS score over time, with repeated measurements at baseline and during follow-up.[3] This helps researchers see whether the treatment changes the course of the disease.[3]

Who may participate

Each study has a different target group, based on the disease being studied.[1][2][3][4][5] The cancer trials focus on adults with advanced or metastatic disease, while the rare disease trial focuses on patients with Kearns-Sayre syndrome.[1][2][3][4][5]

  • Advanced or metastatic colorectal cancer: patients are studied to see whether the treatment plan can control tumour growth and improve response.[1]

  • Metastatic gastric adenocarcinoma: patients with advanced stomach cancer are studied in a randomized Phase 2 design.[2]

  • Metastatic esophageal carcinoma: a larger Phase 3 group is used to compare survival outcomes.[4]

  • Borderline resectable pancreatic adenocarcinoma: patients are studied before surgery to see whether treatment can make tumour removal more successful.[5]

  • Kearns-Sayre syndrome: patients with this rare condition are studied to see whether folinic acid treatment improves clinical scores.[3]

Key points for patients

ANHYDROUS CALCIUM FOLINATE appears in trials across very different diseases, so its role depends on the study question.[1][2][3][4][5] In cancer, the research is mainly about treatment response, survival, and surgery results.[1][2][4][5] In the rare disease study, the focus is on symptom and disease-score changes over time.[3]

Trial ID Phase Condition studied Status Enrollment
2023-506517-22-00 Phase 1 Advanced or metastatic colorectal cancer Authorised 201
2023-506753-38-00 Phase 2 Metastatic gastric adenocarcinoma Authorised 120
2023-503730-45-00 Phase 2 Kearns-Sayre syndrome Authorised 18
2022-501342-29-00 Phase 3 Esophageal carcinoma Completed 877
NCT05083247 Phase 2 Pancreatic adenocarcinoma Authorised 256

FAQ

  • What is being studied in trials of ANHYDROUS CALCIUM FOLINATE? The trials study ANHYDROUS CALCIUM FOLINATE in different treatment plans, often together with other medicines. Some studies look at cancer treatment, while one study looks at Kearns-Sayre syndrome and cerebral folate deficiency.
  • Who can take part in these trials? The target groups include people with advanced or metastatic colorectal cancer, metastatic gastric cancer, metastatic esophageal carcinoma, borderline resectable pancreatic adenocarcinoma, and Kearns-Sayre syndrome. Each trial has its own entry rules.
  • What phases are these trials in? The trials listed are in Phase 1, Phase 2, or Phase 3. Earlier phases focus more on safety and dose finding, while later phases test how well the treatment works in larger groups.
  • What outcomes are the trials measuring? The studies measure outcomes such as objective response rate, overall survival, disease-free survival, residual tumour resection, and disease scores like the International Pediatric Mitochondrial Disease Scale. Some trials also measure safety events.
  • Are these trials already open? Yes. The listed studies are authorised or completed. This means some are still ongoing or open for participation, while one has finished.

Ongoing Clinical Trials on ANHYDROUS CALCIUM FOLINATE

  • Study on EXL01 with Nivolumab and FOLFOX for First-Line Treatment in Patients with PD-L1 CPS ≥5 Metastatic Gastric Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    France

  • Study on the Effects of Calcium Folinate in Patients with Kearns-Sayre Syndrome and Cerebral Folate Deficiency

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Amivantamab and Chemotherapy Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Italy Spain

  • Study on Preoperative Treatment with mFOLFIRINOX or Gemcitabine-Paclitaxel for Patients with Borderline Resectable Pancreatic Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Belgium

  • Study on the Effectiveness and Safety of Pembrolizumab, Lenvatinib, and Chemotherapy for Patients with Metastatic Esophageal Cancer

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Denmark France Hungary Italy Romania Spain

Glossary

  • Phase 1: A first-stage trial that mainly checks safety, side effects, and the best dose or treatment setup.
  • Phase 2: A trial that looks more closely at whether the treatment works and continues to monitor safety.
  • Phase 3: A larger trial that compares treatments and often looks at major outcomes such as survival.
  • Interventional study: A study where researchers give a treatment or compare treatment plans to see what happens.
  • Objective response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Overall survival (OS): How long patients live after starting treatment, no matter the cause of death.
  • Disease-free survival (DFS): The length of time after treatment during which the cancer does not come back.
  • Residual tumour (R0) resection: Surgery that removes the tumour with no visible cancer left at the edges of the removed tissue.
  • Dose limiting toxicity (DLT): A side effect serious enough to limit how much treatment can be given.
  • International Pediatric Mitochondrial Disease Scale (IPMDS): A score used to measure how severe mitochondrial disease is in children and young people.
  • Randomized: Patients are put by chance into different treatment groups so the results are fairer.

References

  1. https://clinicaltrials.gov/study/2023-506517-22-00
  2. https://clinicaltrials.gov/study/2023-506753-38-00
  3. https://clinicaltrials.gov/study/2023-503730-45-00
  4. https://clinicaltrials.gov/study/2022-501342-29-00
  5. https://clinicaltrials.eu/trial/study-on-preoperative-treatment-with-mfolfirinox-or-gemcitabine-paclitaxel-for-patients-with-borderline-resectable-pancreatic-cancer/