Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02893930|
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : September 9, 2016
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neuroendocrine Tumor G1 Pancreatic Neuroendocrine Tumor G2 Refractory Pancreatic Neuroendocrine Carcinoma||Drug: Sapanisertib||Phase 2|
I. To evaluate overall response rate associated with sapanisertib (MLN0128 [TAK-228]) in patients with advanced pancreatic neuroendocrine tumors (PNETs).
I. To evaluate progression-free survival (PFS) associated with MLN0128 (TAK-228) in patients with advanced pancreatic neuroendocrine tumors (PNETs).
II. To measure the safety and tolerability of MLN0128 (TAK-228) in patients with advanced PNETs.
III. To evaluate disease control rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.
IV. To measure duration of response rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.
Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
Experimental: Treatment (sapanisertib)
Patients receive sapanisertib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Objective tumor response (complete response + partial response) as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 5 years ]If at the end of the second stage, 4 or more patients attain objective response to therapy, the null hypothesis will be rejected and the agent will be recommended for further evaluation.
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ]Analysis will be descriptive in nature.
- Incidence of adverse events [ Time Frame: Up to 5 years ]Will be graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Disease control rate [ Time Frame: Up to 5 years ]Analysis will be descriptive in nature.
- Duration of response [ Time Frame: Up to 5 years ]Analysis will be descriptive in nature.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893930
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|Principal Investigator:||Lakshmi Rajdev||ECOG-ACRIN Cancer Research Group|