Completed
A Japanese Single Center, Open-label, Phase I Trial of TH-302 Given Intravenously to Subjects With Solid Tumors as Monotherapy or to Subjects With Advanced Pancreatic Cancer in Combination With Gemcitabine
What is being tested
Evofosfamide
+ Evofosfamide
+ Evofosfamide
Drug
Who is being recruted
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Over 20 Years
+31 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: April 2013
Summary
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: October 15, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: April 18, 2013
Actual date on which the first participant was enrolled.This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic cancer.
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: October 15, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms
Criteria
11 inclusion criteria required to participate
Acceptable liver function, renal function, hematologic status and coagulation status as defined in the protocol
At least 20 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Effective contraception for both male and female subjects if the risk of conception exists
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20 exclusion criteria prevent from participating
A history of allergic reactions
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Anti-cancer treatment prior to trial entry
Cardiac disease with New York Heart Association (NYHA) Class 3 or 4, within 6 months prior to the trial entry
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Research Site
Tokyo, JapanCompleted2 Study Centers