This trial is evaluating whether Calaspargase Pegol-mknl will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Cancer of Pancreas. Measurement will happen over the course of Up to 30 days after last dose of study intervention.
This trial requires 24 total participants across 2 different treatment groups
This trial involves 2 different treatments. Calaspargase Pegol-mknl is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
There has not been much research on new therapies for [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) compared to other cancers. In this review, we summarize the current findings on therapeutics, including systematic reviews, and offer some suggestions for future research.
Calaspargase pegol-mknl is efficacious in the treatment of advanced pancreatic cancer. The plasma half life of calaspargase pegol-mknl is prolonged by approximately 4 days relative to free calaspargase.
The risk of developing pancreatic cancer is increased by smoking, diabetes, obesity, and family history of pancreatic cancer. The risk is further increased by having a family member who died from pancreatic cancers. There is no evidence that pancreatic cancer is prevented by regular physical activity, healthy diet, weight loss, or stopping smoking.
The most common adverse events reported after repeated administration of calaspargase pegol-mknl were fatigue, headache, nausea, vomiting, constipation, diarrhea and abdominal pain. Most of these adverse events were mild to moderate in severity and did not require any specific treatment.
There is a lack of consistency between the current recommendations for the treatment of patients with pancreatic cancer; however, there is a need for more randomized controlled studies to provide evidence based guidelines for the management of patients with this malignancy.
A major problem is knowing how early to seek treatment. The late diagnosis of pancreatic cancer often results in death. Most early detection programs do not address the issue of presentation of symptoms by individuals with pancreatic cancer.
Calaspargase is an effective treatment for patients with advanced pancreatic ductal adenocarcinoma. This agent has already been approved for the treatment of metastatic breast cancer and myeloma. This drug shows activity against pancreatic carcinoma as well. Further testing in combination with other agents (e.g., gemcitabine) may provide additional benefit to patients with pancreatic malignancies.
Cancer of pancreas was the second most common form of gastrointestinal malignancy seen at our institution. The incidence of pancreatic adenocarcinoma increased during this period. Although the prevalence of adenocarcinoma remains stable, an increasing proportion of cases diagnosed with other types of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) increases the burden of these patients' long-term survival.
The CALP-100 trial (NCT00343923) was designed to evaluate the safety and antitumor activity of the calcineurin inhibitor calaspargase pegol-mknl in patients with advanced pancreatic cancer who had received prior chemotherapy. Results from a recent paper showed that the drug was safe and well tolerated, but failed to demonstrate statistically significant antitumor activity. Further research on this drug is warranted.
Although there are many reports on [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) treatments, the results were not satisfactory. Based on these findings, we made our conclusion that there is no cure for the cancer of pancreas. The reason was that optimal cancer therapy would have been performed on the basis of a precise examination of the cancer cells using a microscope. Also, chemotherapy and radiotherapy could work together to achieve the best results.
The safety profile was similar to that previously reported in a phase II study of this agent in patients with advanced pancreatic cancer. Clinical trials are ongoing.