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 : Recruiting
First Posted : September 9, 2016
Last Update Posted : June 21, 2018
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|