A Phase 2 Study of Linsitinib (OSI-906) in Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors
This phase II trial studies how well linsitinib works in treating younger and adult patients with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : linsitinib
- other : pharmacological study
- other : laboratory biomarker analysis
Phase: Phase 2
Ages Eligible For Study:
- Patients must have histologically confirmed gastrointestinal stromal tumor (GIST) with confirmed genotype of wild-type in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory - Patients will be stratified into pediatric and adult cohorts; patients in the pediatric cohort (age at diagnosis =< 18 years OR diagnosis of Carney Triad or Carney-Stratakis Diad (paraganglioma, pulmonary chondroma) must have received at least sunitinib and have had progression on or intolerance to progression on therapy; patients in the adult cohort (age at diagnosis > 18 years AND no diagnosis of diagnosis of Carney Triad or Carney-Stratakis Diad) have had progression on or intolerance to imatinib therapy as documented by treating physician - Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 - Patients must have measurable disease defined as lesions that can be measured in 2 dimensions by medical imaging techniques such as CT or magnetic resonance imaging (MRI); ascites, pleural fluid, and lesions seen on PET scan only are not considered measurable - White blood cells count >= 2.0 x 10^9/L (being >= 14 days off growth factors) OR - Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (being >= 14 days off growth factors) - Platelet count >= 75 x 10^9/L - Total bilirubin =< 1.5 times the upper limit of normal for age - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x the upper limit of normal (ULN) for the reference lab (=< 5 x the ULN for the reference lab in the presence of known hepatic metastasis, adjusted for age) - Creatinine clearance > 70 ml/min/1.73m^2 or - Serum creatinine < 1.5 x ULN per age and gender - QT interval corrected using Frederica formula (QTcF) interval average of < 450 msec at baseline using the Frederica formula (QTcF) - No concomitant drugs that prolong the QTc interval - No significant cardiac disease - Fasting blood glucose < 150 mg/dL at baseline - Hemoglobin A1C (HbA1c) < 7% at screening - Patients or their legal representative must be able to read, understand and provide written informed consent to participate in the trial - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 7days prior to registration - Patients with diabetes mellitus should have controlled disease on oral medications, defined as: no diabetic ketoacidosis (hyperglycemia, ketonuria, pH < 7.3 and bicarbonate < 15mEq/L) at the time of enrollment or within 30 days prior to enrollment and; no change in oral medications greater than 10% within 30 days prior to enrollment - Patient must be able to swallow to participate in the study - Signed informed consent