Locally advanced unresectable pancreatic adenocarcinoma MedDRA version: 17.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: TH-302
Product Code: TH-302
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not available
CAS Number: 918633-87-1
Current Sponsor code: TH-302
Concentrati
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 - Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST 1.1 criteria (see Appendix III). - Documentation of disease progression since any prior therapy. - Life expectancy of at least 3 months. - Acceptable liver function. - Acceptable renal function. - Acceptable hematologic status. - Other protocol defined inclusion criteria may applied Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. 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. 2. Symptomatic ischemic heart disease. 3. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months). 4. 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. 5. Severe chronic obstructive or other pulmonary disease with hypoxemia 6. Major surgery, other than diagnostic surgery, =28 days prior to the date of randomization. Subject must have completely recovered from surgery. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 8. Treatment of pancreatic cancer with radiation therapy or surgery =28 days prior to the date of randomization. 9. Prior therapy with a hypoxic cytotoxin. 10. Subjects who participated in an investigational drug or device trial =28 days prior to Day 1 of the first cycle. 11. Known infection with HIV, or an active infection with hepatitis B or hepatitis C. 12. 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. 13. Other protocol defined exclusion criteria may applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated locally advanced unresectable or metastatic pancreatic adenocarcinoma.;Secondary Objective: To assess efficacy with resepct to: ? progression free survival (PFS), and ? objective response (OR) and disease control. To assess patient reported outcomes (PROs) with respect to quality of life (QoL) measured with EORTC QLQ-C30 (Version 3) and EQ-5D-5L, and pain measured by a Numerical Rating Scale (NRS). To investigate levels of carbohydrate antigen 19-9 (CA19-9), To assess the safety and tolerability of gemcitabine in combination with TH-302 compared with gemcitabine in combination with placebo.;Primary end point(s): The primary endpoint is Overall Survival (OS) time.;Timepoint(s) of evaluation of this end point: OS will be evaluated when 508 events (deaths) of randomized patients are reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-freee Survival (PFS) Time. - Best Overall Respose Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Disease control Rate according to Response Evaluation Criteria in solid Tumors (RECIST) version 1.1. - Quality of Life (QOL) EuroQuol-5D (EG-5D) Health Outcome questionnaire. - Pain intensitiy using a visual analogue scale (VAS). - Serum CA 19-9 response rate. - Number of participants with treatment-emergent adverse events (TEAE) graded according to National Cancer Institute Common Terminology Criteria for Adverse Eents (NCI CTCAE v.4.03).;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at the same timepoint as OS data is mature. | — |
Countries
Austria, Belgium, Bulgaria, Canada, Czech Republic, European Union, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCommunication Center
Merck KGaA
Outcome results
None listed