Clareo Health | Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
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Keep this study
Lead
ImmunoGenesis
With
Threshold Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age
Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and 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 (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
Documentation of disease progression since any prior therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 3 month
Acceptable liver, renal function and acceptable hematological status
You may not be if
New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
Symptomatic ischemic heart disease
Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
Severe chronic obstructive or other pulmonary disease with hypoxemia
Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
Prior therapy with a hypoxic cytotoxin
Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
