Kinisoquin for Pancreatic Cancer
(CATIQ P3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Kinisoquin to determine its effectiveness in preventing blood clots in individuals with metastatic pancreatic cancer. It compares various doses of Kinisoquin to a placebo (a pill with no active ingredients) to identify the optimal option. Individuals with advanced pancreatic cancer that has spread and who are beginning their first round of chemotherapy may qualify for this study. Participants will be randomly assigned to receive either Kinisoquin or a placebo for 16 weeks. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anticoagulants and high doses of aspirin or other anti-inflammatory drugs, before participating. If you are on these medications, you may need to discuss alternatives with your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Kinisoquin was generally well-tolerated in previous studies, with most patients not experiencing serious side effects. The current trial is in a late stage, typically indicating that the treatment proved safe in earlier tests. Kinisoquin is being tested at two doses, 1000 mg and 2000 mg, and past research found no major safety concerns with these amounts. Although no treatment is entirely risk-free, existing evidence suggests that Kinisoquin is safe enough for testing in this trial to prevent blood clots in pancreatic cancer patients.12345
Why are researchers excited about this trial's treatments?
Most treatments for pancreatic cancer, like chemotherapy and targeted therapies, focus on attacking rapidly dividing cancer cells or specific genetic mutations. But Kinisoquin works differently by targeting unique pathways involved in cancer cell survival and growth, potentially offering a new approach to treatment. Researchers are excited about Kinisoquin because it has a novel mechanism of action that could provide benefits even for patients who don't respond to existing therapies. Additionally, its oral administration makes it easier for patients to take compared to some current intravenous treatments.
What evidence suggests that Kinisoquin might be an effective treatment for pancreatic cancer?
Research has shown that Kinisoquin, which participants in this trial may receive, may help prevent blood clots in people with advanced pancreatic cancer. Previous studies found that this treatment targets dangerous blood clots that can occur in cancer patients. Kinisoquin affects how the blood clots, potentially lowering the risk of these clots forming. Early results suggest that patients who took Kinisoquin had fewer blood clots compared to those who did not. This offers hope that Kinisoquin could be a helpful option for managing blood clot risks in pancreatic cancer.12345
Are You a Good Fit for This Trial?
This trial is for adults with advanced pancreatic cancer that has spread, who are starting their first chemotherapy. They should have a life expectancy over 6 months, be able to do some daily activities (ECOG ≤ 2), and have certain blood and liver function levels within set limits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Kinisoquin or placebo for 16 weeks to evaluate the prevention of thromboembolic events
Interim Analysis
An interim analysis is performed to identify the best performing dose after 26 primary endpoint events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kinisoquin
Trial Overview
The study tests Kinisoquin against a placebo to see if it can prevent blood clots in patients with metastatic pancreatic cancer. It's a Phase 3 trial where participants will randomly receive either the drug or an inactive substance.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin 1000mg, Kinisoquin 2000mg or matching placebo daily. Patients in the 2,000 mg group will receive Kinisoquin at a total daily dose of 2,000 mg, administered orally as four 250 mg Kinisoquin capsules in the morning and four 250 mg Kinisoquin capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.
Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin 1000mg, Kinisoquin 2000mg or matching placebo daily. Patients in the 1,000 mg group will receive Kinisoquin at a total daily dose of 1,000 mg, administered orally as two 250 mg Kinisoquin capsules and two placebo capsules in the morning, and two 250 mg Kinisoquin capsules and two placebo capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.
Patients in this group will be administered placebo orally at 8 capsules per day for 16 weeks (4 capsules in the morning and 4 capsules in the evening).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Quercis Pharma AG
Lead Sponsor
Citations
Study Details | NCT06861088 | The Effect of Kinisoquin on ...
The aim of this study is to evaluate the efficacy of Kinisoquin in prevention of thromboembolic events in patients with metastatic pancreatic cancer. This ...
Kinisoquin for Pancreatic Cancer (CATIQ P3 Trial)
Trial Overview The study tests Kinisoquin against a placebo to see if it can prevent blood clots in patients with metastatic pancreatic cancer.
3.
clinicaltrialsarena.com
clinicaltrialsarena.com/comment/quercis-enlists-clinipace-for-phase-iii-trial-in-pancreatic-cancer-related-venous-thromboembolism-in-40m-60m-fundraise-ceo-says/Quercis Pharma enlists Clinipace for Phase III trial ...
Quercis is working with the CRO Clinipace in a Phase III trial for venous thromboembolism prevention in pancreatic cancer patients.
The Effect of Kinisoquin on Thromboembolic Events in ...
The aim of this study is to evaluate the efficacy of Kinisoquin in prevention of thromboembolic events in patients with metastatic pancreatic ...
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