CRITÈRES D'ÉLIGIBILITÉ |
(EN)
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CRITÈRES D'EXCLUSION |
(EN)
- Presence of frank leptomeningeal disease as a unique central nervous system feature or in association with brain parenchymal measurable lesion(s).
- Symptomatic brain metastases. Note: Patients with asymptomatic treated and untreated brain metastases are eligible.
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Previous local therapy for brain metastases, such as neurosurgery, stereotactic radiotherapy, or whole brain radiotherapy, administered within 6 weeks prior to administration of CAM-H2.
Note: Previous therapy for brain metastases administered at least 6 weeks prior to CAM-H2 administration will be permitted.
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For patients with brain metastases, any increase in corticosteroid dose during the week prior to enrollment.
Note: Corticosteroid treatment in a stable dose or decreasing dose for at least 4 weeks prior to enrollment is allowed.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
- Uncontrolled thyroid disease, defined as free triiodothyronine (T3) and free thyroxine (T4) > 3 x ULN at screening.
- Uncontrolled diabetes defined as a fasting serum glucose > 2 x ULN or glycated hemoglobin levels > 8.5% at screening.
- Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (eg, Crohn's, ulcerative colitis).
- Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).
- Ongoing peripheral neuropathy of Grade > 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
- Symptomatic congestive heart failure of New York Heart Association Class III or IV.
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease.
- Liver disease, including cirrhosis and severe hepatic impairment.
- Active (acute or chronic) or uncontrolled severe infections.
- Known history of HIV, hepatitis B, or active hepatitis C virus at screening.
- Prior investigational anticancer therapy within 4 weeks prior to CAM-H2 administration.
- Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, who have not recovered from side effects of any major surgery (defined as requiring general anesthesia), or have a major surgery planned during the course of the study.
- Other malignancies within the past 3 years except for adequately treated carcinoma of cervix or basal or squamous cell carcinomas of the skin or stage I uterine cancer.
- Radiation therapy for metastatic disease foci outside the brain, administered within 3 weeks before study enrollment.
- Known hypersensitivity to any of the study drugs, including inactive ingredients, including iodine allergy.
- History of significant comorbidities that, in the Investigator's judgement, may interfere with study conduct, response assessment, or informed consent.
- Unable or unwilling to complete the study procedures.
- Patients that cannot be hospitalized in a radionuclide therapy room.
- Patients that are unable to comply with thyroid protective pre-medication.
- Patients in whom bladder catheterization cannot be performed, or in patients who are unwilling to be catheterized if necessary.
- Patients with contraindications for undergoing MRI or CT, including for receiving contrast agents.
- Patient is the Investigator or sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.
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