Gastric Cancer Gastic Cancer
Conditions
Interventions
A single intravenous dose of 148 MBq (+-20%) of the investigational drug will be administered.
D011886, D007297
A single intravenous injection of radiopharmaceuticals
Sponsors
Inaki Anri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric cancer or gastroesophageal junction cancer. 2) Presence of either of the following lesions confirmed by imaging (CT or MRI): 2)-1 Distant metastatic lesion (including recurrent distant metastasis) 2)-2 Locally residual or recurrent lesion 3) Laboratory values within 28 days prior to enrollment must meet all of the following: 3)-1 Bone marrow function a. Absolute neutrophil count >= 1,000/uL b. Platelet count >= 75,000/uL c. Hemoglobin >= 7.0 g/dL 3)-2 Renal function Estimated GFR >= 30 mL/min/1.73 m2 3)-3 Liver function a. ALT = 90% on room air 4) ECOG Performance Status of 0 or 1 within 28 days prior to enrollment. 5) Age >= 18 years at the time of consent. 6) Written informed consent obtained from the subject prior to participation.
Exclusion criteria
Exclusion criteria: 1) Presence of active double (synchronous) malignancy. 2) Presence of any of the following uncontrolled infections: a. Hepatitis B virus infection b. Hepatitis C virus infection c. HIV infection d. Other systemic infections requiring treatment 3) Presence of any of the following uncontrolled conditions or diseases: Symptomatic congestive heart failure, Unstable angina, Myocardial infarction, Arrhythmia, Severe Valvular heart disease, Severe Respiratory disease 4) Presence of psychiatric disorders or psychiatric symptoms judged to make study participation difficult. 5) Pregnant women, women who may be pregnant, or breastfeeding women. 6) Inability to comply with radiation protection instructions given by investigators within the controlled area. 7) Administration, or possibility of administration, of diagnostic or therapeutic radioisotopes other than the study drug during the study period. 8) Previous administration of 64Cu-PD-29875. 9) Any other condition that the principal investigator or sub-investigator judges to make the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion-based PET positivity rate, Patient-based PET positivity rate, Pharmacokinetics, Estimated radiation dose | — |
Contacts
Public ContactAnri Inaki
National Cancer Cener Japan
Outcome results
None listed