Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer (NCT03107780) | Clinical Trial Compass
TerminatedPhase 1
Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer
Stopped: Drug supply issues
United States32 participantsStarted 2018-07-09
Plain-language summary
This phase I trial studies the side effects and best dose of navtemadlin in treating patients with glioblastoma (brain cancer) that is newly diagnosed or has come back (recurrent). Navtemadlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be 18 years of age or older
* Patients must have a Karnofsky performance status \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
* Absolute neutrophil count \>= 1,500/ul
* Platelets \>= 100,000/ul
* Hemoglobin \>= 10 g/dL (transfuse as necessary to raise levels, no transfusions within 7 days of start)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN
* Alkaline phosphatase \< 2.0 x ULN
* Creatinine =\< institutional ULN
* Creatinine clearance \>= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =\< 1.5 x institutional ULN
* Patients must be able to provide written informed consent
* Patients must have MRI within 21 days before starting treatment; patients must be able to tolerate MRI with gadolinium
* Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
* Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation through 5 weeks (wom…
What they're measuring
1
Pharmacokinetics (PK) parameters with target inter-tumor drug concentration at >= 25 nm (Part 1)
Timeframe: Up to 5 years
2
Maximum tolerated dose (MTD) of MDM2 inhibitor AMG 232 (KRT-232) when combined with concomitant radiation therapy (Part 2)