L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    20
  • sponsor
    Helix BioPharma Corporation
Updated on 28 February 2021
ct scan
platelet count
karnofsky performance status
metastasis
liver metastasis
thromboplastin

Summary

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.

Description

The Phase Ib part of the study will apply a standard 3 + 3 algorithm for dose escalation to determine the appropriate L-DOS47 maximum tolerated dose to use in combination with doxorubicin for the Phase II part of the study. Patients will be recruited into 3 cohorts where each cohort will receive increasing weekly dose levels of L-DOS47 in combination with a fixed dose of 20 mg/m2 of doxorubicin weekly. The decision for escalation to the next dose level will be made after all patients in a cohort have completed 4 weeks of combination treatment and the safety data have been reviewed by the Safety Review Committee. If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.

The Phase II part of the study will focus on evaluating preliminary anti-tumor activity, as well as continuing to evaluate safety and tolerability of L-DOS47 in combination with doxorubicin. A further 11 additional patients will be enrolled in this phase of the study, which is designed to ensure patient safety and to detect whether there is a level of anti-tumor activity that would be worth pursuing in a larger clinical trial. Patients will be initiated on the L-DOS47 dose determined in Phase I, in combination with 20 mg/m2 doxorubicin, with tumor marker carbohydrate antigen 19-9 (CA19-9) measurements at each treatment cycle, and radiological assessments every two treatment cycles.

Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

Safety will be assessed by reported adverse events (AEs), serious adverse events (SAEs), physical exams, vital signs, Karnofsky Performance Status, electrocardiogram (ECG), echocardiogram (ECHO)/multigated acquisition scan (MUGA), clinical laboratory evaluations (hematology, chemistry, coagulation and urinalysis), and anti-L-DOS47 antibody levels.

Details
Condition Pancreatic Cancer, Islet Ce417ll Cancer, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment doxorubicin, L-DOS47
Clinical Study IdentifierNCT04203641
SponsorHelix BioPharma Corporation
Last Modified on28 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Pancreatic Cancer?
Do you have any of these conditions: cancer of the pancreas or pancreatic cancers or cancer, pancreatic or Islet Ce417ll Cancer or Pancreatic Cancer?
Do you have any of these conditions: Islet Ce417ll Cancer or cancer, pancreatic or Pancreatic Cancer or cancer of the pancreas or pancreatic cancers?
Do you have any of these conditions: Islet Ce417ll Cancer or Pancreatic Cancer or cancer of the pancreas or cancer, pancreatic or pancreatic cancers?
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
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

Exclusion Criteria

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
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