L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Pancreas Cancer
In brief
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer.
Key facts
- Study ID
- NCT04203641
- Run by
- Helix BioPharma Corporation
- People needed
- 28
- Starts
- 2019-12-11
- Expected to finish
- 2024-10-24
- Last updated by the study team
- 2025-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged ≥ 18 years old
- One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST version 1.1 and screening FDG-PET scan with maximum standardized uptake value (SUV max) ≥ 5.5 for at least one lesion consistent with pancreatic cancer.
- Karnofsky performance status ≥ 70%
- Life expectancy of at least 3 months
- Able to understand the information provided to them and to give written institutional review board (IRB)-approved informed consent prior to any study activities being conducted
- A negative pregnancy test (if of child bearing potential)
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) ≤ 2.5 times upper limit of normal (ULN; if liver metastases are present, then ≤ 5 x ULN is allowed)
- Acceptable renal function as defined by creatinine ≤1.5x institutional upper limits of normal, or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Acceptable hematologic status:
- Granulocyte ≥ 1500 cells/mm3
- Platelet count ≥ 100,000 (plt/mm3)
- Hemoglobin ≥ 9g/dL
- Urinalysis:
- a) No clinically significant abnormalities
- Acceptable coagulation status
- Prothrombin time within 1.5x of normal limits
- Partial thromboplastin time (PTT) within 1.5x of normal limits
- For men and women of child-bearing potential, the use of effective contraceptive methods during the study
- Normal ejection fraction on ECHO or MUGA
You may not qualify if…
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Abnormal ejection fraction on ECHO or MUGA
- Active, uncontrolled bacterial, viral, or fungal infections requiring systematic therapy
- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 3 weeks prior to study entry
- Major surgery within 4 weeks prior to study entry
- Unwillingness or inability to comply with procedures required in this protocol
- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease (eg hydro nephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Patients who are currently receiving any other investigational agent
- Patients with any evidence of uncontrolled brain metastases or carcinomatosis meningitis.
- Patients with marked screening prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 480 milliseconds (CTCAE grade 1) using Fredericia's QT correction formula.
Where it is running
- Scottsdale Healthcare Hospitals DBA HonorHealth — Scottsdale, Arizona, United States
- Atlantic Health System, Morristown Medical Center — Morristown, New Jersey, United States
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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