L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helix BioPharma Corporation
• Collaborator: Theradex
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Male or female aged ≥ 18 years old

2. 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.

3. Karnofsky performance status ≥ 70%

4. Life expectancy of at least 3 months

5. 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

6. A negative pregnancy test (if of child bearing potential)

7. Acceptable liver function:

1. Bilirubin ≤ 1.5 times upper limit of normal

2. 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)

8. 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

9. Acceptable hematologic status:

1. Granulocyte ≥ 1500 cells/mm3

2. Platelet count ≥ 100,000 (plt/mm3)

3. Hemoglobin ≥ 9g/dL

10. Urinalysis:

a) No clinically significant abnormalities

11. Acceptable coagulation status

1. Prothrombin time within 1.5x of normal limits

2. Partial thromboplastin time (PTT) within 1.5x of normal limits

12. For men and women of child-bearing potential, the use of effective contraceptive methods during the study

13. Normal ejection fraction on ECHO or MUGA

Exclusion Criteria:

1. 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

2. Abnormal ejection fraction on ECHO or MUGA

3. Active, uncontrolled bacterial, viral, or fungal infections requiring systematic therapy

4. 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.

5. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 3 weeks prior to study entry

6. Major surgery within 4 weeks prior to study entry

7. Unwillingness or inability to comply with procedures required in this protocol

8. Known infection with HIV, hepatitis B, or hepatitis C

9. 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

10. Patients who are currently receiving any other investigational agent

11. Patients with any evidence of uncontrolled brain metastases or carcinomatosis meningitis.

12. 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.