Clinical Trial: A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)
Brief Summary: A phase II trial to assess the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)
Detailed Summary: The purpose of this study is to evaluate the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)
Sponsor: Grupo Espanol de Tumores Neuroendocrinos
Current Primary Outcome: Activity of palbociclib (PD0332991) considering objective response rate [ Time Frame: 20 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression Free Survival [ Time Frame: Patients will be followed until disease progression, estimating around 12months ]
- Time to Tumor Progression [ Time Frame: Patients will be followed until disease progression, estimating around 12 months ]
- Duration of response [ Time Frame: Patients will be followed until disease progression, estimating around 12 months ]
- Overall Survival [ Time Frame: Patients will be followed until death, estimating around 33 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Safety) [ Time Frame: Patients will be followed until disease progression estimating around 12 months ]Safety would be measured as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Positive expression of tumor biomarkers (Cdk4, Cdk6, fosfo-Rb1, D1 cyclin, p53, Ki67) [ Time Frame: Positive expression of tumor biomarkers at baseline ]Percentage of neoplasique cells with positive expression of the following tumor biomarkers Cdk4, Cdk6, fosfo-Rb1, D1 cyclin, p53, Ki67 would be measured at baseline by immunohistochemistry
Original Secondary Outcome: Same as current
Information By: Grupo Espanol de Tumores Neuroendocrinos
Dates:
Date Received: July 8, 2015
Date Started: May 2015
Date Completion:
Last Updated: June 21, 2016
Last Verified: June 2016