Study to Assess the Safety and Efficacy of Intravenous Injection of the Imaging Agent 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic or Colorectal Cancer.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent form prior to all study procedures.
Male or female patients ≥18 years.
Histologically confirmed locally advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC) or Colorectal cancer (CRC), not amenable to treatment with curative intent.
At least one lesion identified by CT or MRI as being ≥2 cm in the longest diameter on axial plane, which has not been previously treated with external beam radiation.
Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
Estimated life expectancy \>3 months.
Clinically acceptable medical history, physical examination and vital signs findings during the screening period
Adequate organ function as evidence by: Leukocytes ≥2000/μL, Absolute neutrophil count ≥750/μL, Platelets ≥75,000/μL, Haemoglobin ≥10 g/dL, Total serum bilirubin ≤1.5×upper limit of normal range (or in case of hepatic metastases ≤2.5 x upper limit of normal range), Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3×upper limit of normal range (or in case of hepatic metastases ≤5 x upper limit of normal range), Estimated glomerular filtration rate ≥50 mL/min.
Willing and able to comply with study restrictions, including remaining at the clinic for the required time during the study period, and willing to return to the clinic for the follow-up evaluation, as specified in the protocol.
For women of childbearing potential (neither surgically sterile nor post-menopausal defined as no menses for 12 months without an alternative medical cause), a negative highly sensitive pregnancy test must be documented at the screening visit (serum test).
Female patients of childbearing potential (not surgically sterile or post-menopause defined as no menses for 12 months without an alternative medical cause) must use a medically accepted highly effective method of contraception and must agree to use this method for the duration of the study (from screening until 6 months after administration of 111In-IPN01087).
Male patients must agree to use a condom for the duration of the study and for at least 90 days after administration of 111In-IPN01087.
Male patients with female partners of childbearing potential must use a medically accepted highly effective method of contraception and must agree to use this method for the duration of the study and for at least 90 days after administration of 111In-IPN01087.
Receiving, or scheduled to receive, another IIP from 1 month before screening to 1 week after administration of 111In-IPN01087.
Administration of any radiopharmaceutical within eight half lives of that radionuclide before IIP administration.
Any condition that precludes adequate SPECT and/or CT imaging, e.g. patients unable to lie still for the entire imaging time, or metal prosthetics which interfere with CT (hip and knee prosthetics are acceptable).
Clinically significant abnormalities on ECG at screening
Any uncontrolled significant medical, psychiatric or surgical condition or laboratory finding that would pose a risk to patient safety, or interfere with study participation, or interpretation of individual patient results.
Pregnancy, lactation, or breastfeeding.
Unable to understand the nature, scope and possible consequences of the study, in the judgment of the investigator.
You may not be if
Known allergy to the investigational imaging product (IIP) or its excipients administered in this study.
Clareo Health | Study to Assess the Safety and Efficacy of Intravenous Injection of the Imaging Agent 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic or Colorectal Cancer.
