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New treatment option for Solid Tumor
Official title Trial of DFP-14927 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03943004
What this study is testing
What is DFP-14927?
DFP-14927 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I, open-label, single-arm, dose escalation study of DFP-14927 intravenous infusion administered to patients with refractory or relapsed solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically (or cytologically) confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for...
- Aged ≥ 18 years.
- ECOG Performance Status of 0 or 1.
- Adequate clinical laboratory values defined as:
- absolute neutrophil count ≥ 1.5 x 10⁹/L
You likely can't join if
- Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4...
- Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.
- Have had any major bleeding episodes (variceal bleeds, hemorrhagic strokes, internal abdominal bleeds, etc.) within 6 months prior to starting study...
- Known hypersensitivity to any study drug component (such as pegylated medications).
- Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
See the full eligibility criteria
- 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...
- Aged ≥ 18 years.
- ECOG Performance Status of 0 or 1.
- Adequate clinical laboratory values defined as:
- absolute neutrophil count ≥ 1.5 x 10⁹/L
- platelets ≥ 100 x 10⁹/L
- hemoglobin ≥ 9.0 g/dL (transfusions permissible)
- plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ≥ 60 mL/min (Cockcroft-Gault formula)
- total bilirubin ≤ 1.5 x ULN
- alanine transaminase (ALT) and aspartate transaminase (AST) \< 2.5 x ULN (\<5 x ULN if documented hepatic metastases)
- prothrombin time (PT) ≤1.2 x ULN, partial thromboplastin time (PTT) ≤ 1.2 ULN, and international normalized ratio (INR) ≤ 1.5
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, uncontrolled diabetes mellitus, or other organ dysfunctions.
- Patients may have measurable or non-measurable disease as defined by RECIST 1.1.
- Signed Informed-consent prior to the start of any study specific procedures.
- Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month...
- Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for...
- Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.
- Have had any major bleeding episodes (variceal bleeds, hemorrhagic strokes, internal abdominal bleeds, etc.) within 6 months prior to starting study drug.
- Known hypersensitivity to any study drug component (such as pegylated medications).
- Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
- Pregnant or lactating individuals.
- Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
- Known history of HIV, HBV or HCV infection.
- Documented or known bleeding disorder.
- Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
- Clinically evident CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. Patients with...
- Patients with a significant cardiovascular disease or condition, including:
- Myocardial infarction within 6 months of study entry
- NYHA Class III or IV heart failure
- Uncontrolled dysrhythmias or poorly controlled angina.
- History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women). QTc values up to 500 msec will be acceptable where patient's medical history, e.g. bundle branch block...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.