Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven either by histology or cytology previously untreated with chemotherapy or systemic therapy other than:

Radiosensitizing doses of 5-fluorouracil;
Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy.
Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields)
Documentation of disease progression since any prior therapy
ECOG performance status of 0 or 1
Life expectancy of at least 3 months

Acceptable liver function:

Bilirubin less than or equal to 1.5 times upper limit of normal
AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times upper limit of normal (ULN); if liver metastases are present, then less than or equal to 5 times ULN is allowed

Acceptable renal function:

a. Serum creatinine less than or equal to ULN

Acceptable hematologic status (without hematologic support):

ANC greater than or equal to 1500 cells/μL
Platelet count greater than or equal to 100,000/μL
Hemoglobin greater than or equal to 9.0 g/dL
All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose

Exclusion Criteria:

New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Treatment of pancreatic cancer with radiation therapy or surgery within 4 weeks prior to study entry
Prior therapy with an hypoxic cytotoxin
Subjects who participated in an investigational drug or device study within 28 days prior to study entry
Known active infection with HIV, hepatitis B, or hepatitis
Subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to TH- 302
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any reason