Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Conditions
Sponsors
Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)
Threshold Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.At least 18 years of age (At least 20 years of age in Japan) 2.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; 3.Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria 4.Documentation of disease progression since any prior therapy 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6.Life expectancy of at least 3 months 7.Acceptable liver, renal function and acceptable hematological status 8.Other protocol defined inclusion criteria may apply
Exclusion criteria
Exclusion criteria: - 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 - Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall Survival Time | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other -Progression Free Survival Time -Percentage of subjects with best overall response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1) -Percentage of subjects with disease control according to RECIST v.1.1 -Quality of Life (QOL) EuroQuol-5D (EQ-5D) Health Outcome questionnaire -Quality of Life (QOL) Assessment European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) (Version 3.0) -Pain intensity using a Numerical Rating Scale (NRS) -Serum Carcinoma Antigen 19-9 response rate -Number of subjects with treatment-emergent adverse events (TEAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.4.03) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed