Ovarian, Fallopian Tube, or Peritoneal Cancer
Conditions
Sponsors
Yataba Ikuko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients scheduled for debulking surgery, including staging laparotomy for the following reasons: -Diagnosed or clinically suspected strongly to have ovarian, fallopian tube, or peritoneal cancer -Recurrent ovarian, fallopian tube, or peritoneal cancer 2) Patients who understand the informed consent document and can provide written consent of their own free will 3) Patients who are between 18 and 85 years old (at the time of signing the informed consent document) 4) Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 as determined at the time of enrollment 5) Patients who are able to comply with the requirements of the study protocol, including the visit schedule
Exclusion criteria
Exclusion criteria: 1) Patients with a history of or complications from any of the following conditions: - Myocardial infarction - Congestive heart failure - Angina pectoris requiring treatment - Arrhythmia requiring treatment 2) Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, poorly controlled hypertension, diabetes mellitus, etc.) 3) Patients with serious infectious diseases (including active tuberculosis) 4) Patients with multiple active malignancies 5) Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days prior to IMP administration) [Renal function] Serum creatinine: Less than 3 times the upper limit of the institutional standard [Hepatic function] AST: Less than 3 times the upper limit of the institutional standard ALT: Less than 3 times the upper limit of the institutional standard Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard 6) Patients with systolic blood pressure of 90 mmHg or less, or diastolic blood pressure of 50 mmHg or less on the screening examination 7) Female patients who are pregnant, lactating, or may be pregnant 8) Patients who do not intend to use contraception 9) Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs 10) Patients with porphyria 11) Patients who have received cancer chemotherapy within 21 days prior to administration of the study drug or who have undergone resection of cancer within 21 days prior to administration of the study drug 12) Patients with a history of abdominal radiation therapy 13) Patients who have received unapproved or off-label drugs in other clinical trials, etc. within 90 days prior to administration of the investigational drug, and patients who are scheduled to participate in clinical trials, clinical research, etc. (including advanced medical care) during the trial period 14) Other patients who are judged to be inappropriate by the principal or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of biopsy tissue specimens under blue and white illumination | — |
Contacts
Public ContactIkuko Yataba
SBI Pharmaceuticals Co., Ltd.
Outcome results
None listed