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Histone Deacetylase Inhibitor
DFP-14927 for Cancer
Phase 1
Recruiting
Led By Jaffer Ajani, MD
Research Sponsored by Delta-Fly Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Patients must have histologically (or cytologically) confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available. Note: For expansion cohorts patients must have histologically (or cytologically) confirmed diagnosis of gastroesophageal cancer, pancreatic cancer, or cholangiocarcinoma that has relapsed or is refractory to standard therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-study and every 8 weeks through study completion, an average of 6 months
Awards & highlights
Study Summary
This trial is testing a new treatment called DFP-14927 for patients with solid tumors that have not responded to other treatments. It is a small study that aims to determine the appropriate dose of the
Who is the study for?
This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments or lack effective treatment options. Specifically, it includes those with certain types of gastroesophageal, pancreatic, or cholangiocarcinoma cancers. Participants must be relatively healthy overall (ECOG status 0-1) and have adequate organ function.Check my eligibility
What is being tested?
The study tests DFP-14927, a new drug given through an IV. It's in Phase I where researchers are trying different doses to see what's safe for people whose solid tumors have stopped responding to regular cancer therapies.See study design
What are the potential side effects?
Since this is a Phase I trial primarily focused on safety and finding the right dose, specific side effects of DFP-14927 aren't listed but can include typical reactions related to cancer drugs such as fatigue, nausea, blood count changes, and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
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My cancer is confirmed and has not responded to standard treatments.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at pre-study and every 8 weeks through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-study and every 8 weeks through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the maximum tolerated dose (MTD)
Dose-Limiting Toxicity (DLT)
Recommended Phase II Dose (RP2D)
Secondary outcome measures
Determine objective response rate (CR or PR) in response to DFP-14927 study treatment
Duration of response
PK parameters to be determined using area under the concentration curve (AUC)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DFP-14927Experimental Treatment1 Intervention
DFP-14927: weekly IV infusion, 28 day treatment cycle
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Who is running the clinical trial?
Delta-Fly Pharma, Inc.Lead Sponsor
4 Previous Clinical Trials
581 Total Patients Enrolled
Jaffer Ajani, MDPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
1,885 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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