Ponsegromab for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ponsegromab for individuals with advanced pancreatic cancer experiencing cachexia, a condition causing severe weight loss and muscle wasting. The study aims to determine if adding ponsegromab to standard chemotherapy is more effective and safe than chemotherapy with a placebo (a treatment with no active drug). Participants will receive either a low or high dose of ponsegromab or a placebo, administered as injections every four weeks. This trial may suit those diagnosed with metastatic pancreatic ductal adenocarcinoma and experiencing significant weight loss despite ongoing chemotherapy. As a Phase 2, Phase 3 trial, it focuses on evaluating ponsegromab's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In previous studies, ponsegromab has proven to be safe. Research found that only 8.9% of patients experienced unwanted effects from the drug. Importantly, no major patterns of negative effects emerged. Another study reported that 70% of patients taking ponsegromab experienced side effects, but interestingly, 80% of those on a placebo (a dummy treatment) also had side effects. This suggests that many side effects might not be caused by the drug itself.
Earlier trials with ponsegromab, administered every three weeks, showed it was generally safe and well-tolerated. Overall, ponsegromab appears to be a safe treatment option based on these studies.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy drugs like gemcitabine or FOLFIRINOX, ponsegromab offers a novel approach by targeting specific pathways involved in cancer growth. Researchers are excited about ponsegromab because it introduces a unique mechanism of action that could potentially improve treatment efficacy. Additionally, it is administered as a subcutaneous injection, which can be more convenient compared to traditional intravenous chemotherapy. This new delivery method might also lead to fewer side effects, making it an appealing option for patients and healthcare providers.
What evidence suggests that ponsegromab might be an effective treatment for pancreatic cancer?
Research has shown that ponsegromab can aid individuals with cancer-related weight loss and muscle wasting by enhancing body weight, muscle mass, and physical function. In this trial, participants will receive either a 200 mg dose, a 400 mg dose of ponsegromab, or a placebo. Studies have found that those taking ponsegromab experienced improved appetite and fewer symptoms of severe weight loss and muscle wasting, known as cachexia. Specifically, a 400 mg dose of ponsegromab led to significant improvements in physical activity and overall quality of life. Additionally, ponsegromab continued to help increase body weight over an extended period. These findings suggest that ponsegromab may effectively address weight loss and muscle problems in individuals with advanced pancreatic cancer.12678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic cancer that has spread, causing significant weight loss and fatigue. Participants must have experienced weight loss as per Fearon criteria, be able to perform daily activities (ECOG PS ≤1), expect to live at least 4 more months, have signed consent forms, and completed the first cycle of chemotherapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive systemic chemotherapy plus ponsegromab or placebo for the first-line treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants can continue receiving ponsegromab for up to 12 months after the double-blind portion
What Are the Treatments Tested in This Trial?
Interventions
- Ponsegromab
Trial Overview
The study tests the effectiveness and safety of adding Ponsegromab to standard chemotherapy versus using a placebo with chemotherapy in treating metastatic pancreatic ductal adenocarcinoma accompanied by cachexia (weight loss).
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
ponsegromab 200 mg subcutaneous injection every 4 weeks
ponsegromab 400 mg subcutaneous injection every 4 weeks
Match placebo subcutaneous injection every 4 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
1.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizer-presents-positive-data-phase-2-study-ponsegromabPfizer Presents Positive Data from Phase 2 Study of ...
This study showed us those who received ponsegromab had improvement in body weight, muscle mass, quality of life, and physical function.
Ponsegromab for the Treatment of Cancer Cachexia
Improvements were observed across measures of appetite and cachexia symptoms, along with physical activity, in the 400-mg ponsegromab group ...
NCT06989437 | A Study to Learn About the Medicine ...
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue.
4.
curetoday.com
curetoday.com/view/open-label-extension-of-ponsegromab-shows-efficacy-in-cancer-associated-cachexiaOpen-Label Extension of Ponsegromab Shows Efficacy in ...
Ponsegromab treatment over 64 weeks resulted in sustained improvements in body weight and suppression of growth differentiation factor 15 ...
Phase 2 study of the efficacy and safety of ponsegromab in ...
The primary objective of this phase 2 study is to assess the effect of ponsegromab on body weight in patients with cancer, cachexia and elevated GDF‐15 ...
A Phase Ib First-In-Patient Study Assessing the Safety ...
Overall, this first-in-patient study demonstrates that repeated (every 3 weeks) subcutaneous administration of 200 mg ponsegromab was generally safe and well ...
NCT05546476 | Study of the Efficacy and Safety ...
A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and ...
8.
oncnursingnews.com
oncnursingnews.com/view/open-label-ponsegromab-appears-effective-in-cancer-associated-cachexiaOpen-Label Ponsegromab Appears Effective in Cancer ...
Ponsegromab treatment over 64 weeks resulted in sustained improvements in body weight and suppression of growth differentiation factor 15 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.