Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
With
Threshold Pharmaceuticals
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 20 years of age
Signed written informed consent form
Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available
Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy or systemic therapy
Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Acceptable liver function, renal function, hematologic status and coagulation status as defined in the protocol
No clinically significant abnormalities in urinalysis
Effective contraception for both male and female subjects if the risk of conception exists
You may not be if
Prior anti-cancer treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Prior treatment with gemcitabine for their advanced or metastatic pancreatic cancer, except for radiosensitizing doses of gemcitabine
Prior radiotherapy to more than 30 percent of the bone marrow within 6 months prior to the trial entry
Cardiac disease with New York Heart Association (NYHA) Class 3 or 4, within 6 months prior to the trial entry
Clinically significant (that is, active) cardiovascular disease
Known brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for at least 3 months at the trial entry)
Previously treated malignancies other than the current disease for at least 5 years at the trial entry
Severe chronic obstructive or other pulmonary disease major surgery, within 4 weeks prior to the trial entry, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Anti-cancer treatment prior to trial entry
Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
Known infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
A history of allergic reactions
Taking a medication that is either moderate or strong inhibitor or inducer of cytochrome P450 (CYP)3A4 or is a sensitive substrate of other cytochrome P450
Pregnancy or lactation period
Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
Unwillingness or inability to comply with the trial protocol for any reason
Legal incapacity or limited legal capacity
Clareo Health | A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer
