ODM-212 for Pancreatic Cancer
(TEADCO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ODM-212, to evaluate its effectiveness when combined with other treatments for various cancers, including pancreatic cancer, mesothelioma, and NSCLC with a KRAS mutation. The goal is to determine the optimal dose and understand how these combinations can combat tumors. Individuals with metastatic pancreatic cancer eligible for nab-paclitaxel and gemcitabine treatments might be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, providing an opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, immunotherapy, or other anti-cancer treatments within 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining ODM-212 with gemcitabine and nab-paclitaxel is generally well-tolerated. Studies on gemcitabine and nab-paclitaxel, both chemotherapy drugs, have indicated their safety and effectiveness in treating pancreatic cancer. Patients in these studies experienced manageable side effects, suggesting a favorable safety profile.
For ODM-212 in other combinations, direct evidence remains limited. However, the ongoing trial is in phase 1/2, focusing on testing safety and determining the optimal dose. This early phase involves careful monitoring of the treatment's safety for humans. Overall, the evidence appears promising, but ongoing trials will provide more concrete safety data.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ODM-212 for pancreatic cancer because it introduces a new mechanism of action that targets cancer cells differently than standard chemotherapy options like gemcitabine and nab-paclitaxel. While traditional treatments often focus on directly killing rapidly dividing cells, ODM-212 is designed to disrupt specific pathways that cancer cells rely on to grow and spread. This targeted approach could potentially lead to more effective and less toxic treatments, offering hope for improved outcomes in a disease that has historically been challenging to treat. Additionally, in combination with other agents like gemcitabine, nab-paclitaxel, and sotorasib, ODM-212 may enhance the effectiveness of existing therapies, providing a multifaceted attack on cancer cells.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
Research has shown that combining gemcitabine and nab-paclitaxel effectively treats pancreatic cancer. In studies, patients receiving this combination lived an average of 13.87 months, longer than those taking gemcitabine alone. The time before disease progression improved to 5.37 months, compared to 2.80 months with only gemcitabine. The overall response rate, which measures tumor shrinkage or disappearance, was about 36.6%. In this trial, one treatment arm will evaluate ODM-212 combined with gemcitabine and nab-paclitaxel for pancreatic cancer, aiming to assess its potential benefits.12678
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or metastatic mesothelioma, pancreatic cancer, or non-small cell lung cancer. Participants must be able to take oral medication, have a good performance status, and specific genetic markers or treatment history depending on their cancer type.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive increasing doses of ODM-212 in combination with anti-cancer therapy to evaluate safety and tolerability
Dose Expansion/Optimisation
Participants receive optimized doses of ODM-212 in combination with anti-cancer therapy to further evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ODM-212
Trial Overview
The study tests different treatments based on cancer type: ODM-212 alone or combined with other drugs like gemcitabine/nab-paclitaxel (for pancreatic), sotorasib (for NSCLC with KRAS G12C mutation), and ipilimumab/nivolumab (for mesothelioma). The trial has two parts: finding the best dose and then testing effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Orion Corporation, Orion Pharma
Lead Sponsor
Liisa Hurme
Orion Corporation, Orion Pharma
Chief Executive Officer since 2022
PhD in Biochemistry, University of Helsinki
Hilpi Rautelin
Orion Corporation, Orion Pharma
Chief Medical Officer since 2023
MD, University of Turku
Citations
NAB-paclitaxel and gemcitabine in metastatic pancreatic ...
Patients received a median six cycles (range 1–14) of treatment. Overall response rate was 36.6 %; median progression-free survival was 6.7 months [(95 % ...
The effectiveness of nab-paclitaxel plus gemcitabine ... - PMC
Nab-P/Gem resulted in OS of 13.87 months compared to 8.5 months in patients receiving Gem. The same trend was achieved in PFS, 5.37 versus 2.80 ...
3.
ascopost.com
ascopost.com/issues/march-10-2021/mfolfirinox-or-gemcitabinenab-paclitaxel-for-resectable-pancreatic-cancer/mFOLFIRINOX or Gemcitabine/Nab-paclitaxel for ...
Two-year overall survival was 47% with mFOLFIRINOX and 48% with gemcitabine/nab-paclitaxel for all eligible patients starting treatment for resectable ...
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This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic ...
Efficacy and safety of the S-1, nab-paclitaxel, and gemcitabine ...
This retrospective analysis demonstrates that the S-1/nab-paclitaxel/gemcitabine triplet regimen significantly improves survival outcomes, while ...
NCT05497778 | A Phase 1b Study of Gemcitabine and ...
Primary Safety Objective: To evaluate the safety and tolerability of IM156 with Gem+NP in patients with metastatic PDAC. Exploratory Efficacy Objective:.
A Phase 3, Randomized, Double-Blind, Placebo-controlled ...
A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of Gemcitabine and Nab-Paclitaxel Combined with Momelotinib in Subjects with Previously Untreated ...
A Review on the Efficacy and Safety of Nab-Paclitaxel ...
A review on the efficacy and safety of nab-paclitaxel with gemcitabine in combination with other therapeutic agents as new treatment strategies in pancreatic ...
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