Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Pancreatic Neuroendocrine Tumor G1, Pancreatic Neuroendocrine Tumor G2, Refractory Pancreatic Neuroendocrine Carcinoma

In brief

This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT02893930

Run by

National Cancer Institute (NCI)

People needed

13

Starts

2017-04-28

Expected to finish

2022-12-21

Last updated by the study team

2023-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment
• Refractory disease to treatment with an mTOR inhibitor
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
• Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
• Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
• Patients must have measurable disease
• Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment
• NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)
• Prior or concurrent therapy with somatostatin analogue (SSA) is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment
• Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously
• NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must be able to swallow intact capsules
• Leukocytes >= 3,000/mm\^3 (within less than or equal to 14 days prior to registration)
• Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L (within less than or equal to 14 days prior to registration)
• Hemoglobin >= 10 g/dL (within less than or equal to 14 days prior to registration)
• Platelets >= 100 x 10\^9/L (within less than or equal to 14 days prior to registration)
• Total serum bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within less than or equal to 14 days prior to registration)
• Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min (within less than or equal to 14 days prior to registration)
• NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation
• Glycosylated hemoglobin (HbA1c) < 7.0% (within less than or equal to 14 days prior to registration)
• Fasting serum glucose =< 130 mg/dL (within less than or equal to 14 days prior to registration)
• Fasting triglycerides =< 300 mg/dL (within less than or equal to 14 days prior to registration)
• Diabetics are allowed if:

You may not qualify if…

• Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity
• Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start
• Patient must NOT have had previous treatment with any PI3K or AKT inhibitor
• NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
• Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions:
• Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR
• Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
• No more than 3 prior systemic treatment regimens for advanced PNET
• Patients with a history of the following within =< 6 months of study entry are NOT eligible:
• Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
• Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures
• Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
• New York Heart Association (NYHA) class III or IV heart failure
• Pulmonary embolism
• Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including:
• Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed
• Pulmonary hypertension
• Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air
• QT syndrome, or torsades de pointes
• Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement
• Medically significant (symptomatic) bradycardia
• History of arrhythmia requiring an implantable cardiac defibrillator
• Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long
• Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELGIBLE because of the potential for pharmacokinetic interactions with MLN0128 (TAK-228)

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• PCR Oncology — Arroyo Grande, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Sutter Davis Hospital — Davis, California, United States
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Memorial Medical Center — Modesto, California, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Palo Alto Medical Foundation-Santa Cruz — Santa Cruz, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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