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Anti-metabolites
ZN-c3 + Gemcitabine for Pancreatic Cancer
Phase 2
Recruiting
Led By Brandon Huffman, MD
Research Sponsored by Brandon Huffman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a pathologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches based on the judgement of the treating investigator. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible.
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial is testing a new treatment for pancreatic cancer patients using two drugs.
Who is the study for?
This trial is for adults over 18 with advanced pancreatic adenocarcinoma who've had no more than one prior platinum-based chemotherapy in the metastatic setting. They must have measurable disease, adequate organ function, and agree to use contraception. Excluded are those with previous WEE1 inhibitor treatment, certain CNS diseases, hypersensitivity to study drugs, recent major surgery or inability to swallow pills.Check my eligibility
What is being tested?
The trial tests the combination of ZN-c3 (a WEE1 tyrosine kinase inhibitor) and Gemcitabine (a nucleoside metabolic inhibitor) for safety and effectiveness against pancreatic cancer. Participants will receive both medications under controlled conditions to evaluate how well they work together.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection, gastrointestinal issues affecting absorption of medication, possible liver complications due to hepatitis B or C history requirements, and general drug sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer cannot be cured with standard treatments.
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I am 18 years old or older.
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My cancer can be measured by scans and I agree to have biopsies before and during treatment.
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My cancer did not respond or worsened after platinum-based treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month Progression-Free Survival (PFS) Rate
Secondary outcome measures
Grade 3-5 Treatment-related Toxicity Rate
Median Overall Survival (OS)
Median Progression-Free Survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ZN-c3 + GemcitabineExperimental Treatment2 Interventions
Study procedures will be conducted as follows:
Cycle 1 - End of Treatment
Days 1 - 5 of 21-day cycle: Predetermined dose of ZN-c3 1x daily.
Days 8 - 12 of 21-day cycle: Predetermined dose of ZN-c3 1x daily.
Days 15 - 19 of 21-day cycle: Predetermined dose of ZN-c3 1x daily.
Day 1 and 8 of 21-day cycle: Predetermined dose of Gemcitabine 1x daily.
On-treatment tumor biopsy will be collected on either Cycle 1 Day 9 - 10 or Cycle 2 Day 9 - 10.
Tumor assessment by Computerized Tomography (CT) or Magnetic Resonance Imaging scan every 8 weeks while on treatment.
End of treatment visit with tumor assessment by CT or MRI and optional tumor biopsy.
Follow up visit every 2 months after treatment has ended.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemzar
2018
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Brandon HuffmanLead Sponsor
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,339 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncIndustry Sponsor
7 Previous Clinical Trials
810 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned ZN-c3 + Gemcitabine for clinical use?
"According to our team at Power, ZN-c3 + Gemcitabine has achieved a safety score of 2 due its Phase 2 status. Clinical evidence exists that supports the medication's safety but there is no proof yet that it will be efficacious."
Answered by AI
Is this clinical trial still open to new participants?
"Clinicaltrials.gov attests that this medical trial, which launched on the 1st of September 2023 and was last updated 23rd August 2022, is no longer seeking volunteers. Nevertheless there are currently 1429 other clinical trials welcoming participants."
Answered by AI
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