A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Dif… (NCT02806648) | Clinical Trial Compass
CompletedPhase 2
A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)
Spain21 participantsStarted 2015-05
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of \< or = 20% (well and moderately differentiated) with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
✓. Overexpression of Cdk4 and/or phospho-Rb1 and/or cyclin D1 in tumor tissue sample from tumor biopsy or prior primary tumor resection (Molecular study will be conducted at CNIO and logistic is described later). Therefore availability of paraffin-embedding tumor tissue sample is needed.
✓. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
✓. Previous treatments with chemotherapy, antiangiogenics, or interferon are permitted providing that toxicity has resolved to \< grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment. Patients may be treated with somatostatin analogues during the trial. Concomitant interferon treatment is not permitted.
✓. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
✓. Able to swallow oral compound
✓. Male or female, 18 years of age or older.
✓. ECOG performance status less than 2.
Exclusion criteria
✕. Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract.
What they're measuring
1
Activity of palbociclib (PD0332991) considering objective response rate
✕. Prior treatment on Cdk4 inhibitor under clinical trial.
✕. Creatinine clearance \< 40 ml/min using Cockroft and Gault formula.
✕. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non-target metastatic lesions.
✕. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken concurrently or within last 3 months prior to randomization
✕. Prior radiation therapy to \>25% of the bone marrow.