Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01856933
Eligibility Criteria:
Inclusion Criteria:
* Males and females Histologically confirmed GBM (Patients with gliosarcoma are also eligible)
* Assessable or measurable disease by MRI
* Progression after prior treatment that includes radiation, temozolomide and bevacizumab.
-\> 4 weeks since prior chemotherapy, bevacizumab and other systemic treatment and \> 3 weeks from prior radiation.
* age \>18 years
* Weight \< 150 kg.
* Karnofsky performance score \> 60
* Life expectancy \>12 weeks
* Brain MRI within 21 days prior to registration
* Laboratory results requirements
* Absolute neutrophil count (ANC) ≥ 1000/mm3.
* Platelets (Plt) ≥ 100,000/mm3
* Hemoglobin (Hgb) ≥ 8.0 g/dL
* Total bilirubin ≤ 2.0 mg/dL
* Serum alanine transferase/ Serum aspartate transaminase (ALT/AST) ≤ 2.5x the upper limit of normal (ULN)
* Serum creatinine ≤ 2.0 mg/dL
* Pancreatic Amylase (p-amylase) ≤ the ULN
* Negative serum pregnancy test for women of child-bearing potential
* Stable corticosteroid dose at least 14 days prior to registration
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs. A list of AED that cause modest or no induction of hepatic metabolic enzymes will be discussed
Exclusion Criteria:
* Non-GBM primary invasive malignant neoplasm within the five years prior to screening except for:
* keratinocyte (non-melanoma) (i.e., basal cell, squamous cell) carcinoma of the skin; or low-grade papillary superficial transitional cell carcinoma of the bladder.However, patients with stage 1 cancers not requiring cancer therapy including chemotherapy or hormone therapy, for which a lifespan of greater than 3 years without treatment is expected (such as early stage prostate cancer) may be enrolled.
* Clinically significant cardiac disease (New York Heart Association Class III/ IV or severe debilitating pulmonary disease
* Subjects with QTc\>500 msec (either Bazzett's or Fridericia's method)
* Radiation therapy, cytotoxic chemotherapy, bevacizumab or other treatment for GBM within previous three weeks
* Evidence of an active infection requiring ongoing intravenous antibiotic therapy
* Any toxicity ≥ grade 2 (non-laboratory) (NCI CTCAE, Version 4.03) prior to first dose of study drug
* Prior treatment with PSMA ADC or other therapies targeting PSMA, or other anti-body drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME)
* Known hypersensitivity reactions to PSMA ADC or any of its components.
* Any medical condition that in the opinion of the Investigator may interfere with a subject's participation in or compliance with the study
* Patients with a prior history of pancreatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01856933
Study Brief:
Protocol Section:
NCT01856933