CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

Summary

CEND-1, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

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

Details

• Lead Sponsor: DrugCendR Inc.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Patients with histologically confirmed metastatic pancreatic ductal carcinoma

• One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1.

• Eligible for treatment with nabpaclitaxel and gemcitabine

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 3 months

• Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts

• The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent

• A negative serum pregnancy test (if a premenopausal female patient)

• Acceptable liver function: Bilirubin ≥ 1.5 times upper limit of normal; AST (SGOT) < 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed).

• Acceptable renal function: Serum creatinine within normal limits; calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal by the Cockroft-Gault equation.

• Acceptable hematologic status: Granulocyte ≥ 1500 cells/mm3; Platelet count ≥ 100,000 plt/mm3; Hemoglobin ≥ 9 g/dL.

• Urinalysis: No clinically significant abnormalities.

• Acceptable coagulation status: PT within normal limits; PTT within normal limits.

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

Exclusion Criteria:

• Prior chemotherapy or any other investigational agents for the treatment of pancreatic cancer.

• Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.

• Participants with known brain metastases.

• 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.

• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.

• Pregnant or nursing women. Women of child-bearing potential and men must agree to use adequate contraception.

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

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

• Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions per physician judgement) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.