A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
This trial is active, not recruiting.
|Start date||September 2014|
|End date||June 2016|
|Trial size||18 participants|
|Trial identifier||NCT02132468, OX4218s|
This study will investigate the safety, symptoms and biomarker response of subjects with biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic PNETs or GI-NETs with elevated biochemical markers who have relapsed during or after receiving prior standard of care therapies, including octreotide, chemotherapy or targeted therapy.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|,||not available||no longer recruiting|
|Stanford, CA||Stanford University School of Medicine||no longer recruiting|
|Lexington, KY||Markey Cancer Center, Clinical Research Office||no longer recruiting|
|Bronx, NY||Montefiore||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Milwaukee, WI||Froedtert Hospital, Medicial College of Wisconsin||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Change from one or more baseline biomarker values for each patient to each study visit and study end
time frame: 4 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Ability to read, understand and provide written consent to participate in the study - Age ≥ 18 years - Biopsy-proven well-differentiated, low-to-intermediate-grade PNET or GI-NET with elevated (> ULN) biomarkers (serotonin, 5-hydroxyindoleacetic acid (5-HIAA), chromogranin A (CgA), neurokinin A, and neuron-specific enolase (NSE)) - Life expectancy > 12 weeks - Must have received or may still be receiving one or more therapies including octreotide or serotonin synthesis inhibitor (SSI) or other somatostatin analogues - Confirmed progressive disease within 18 months of enrollment on study - Recovered from prior radiation therapy or surgery - Eastern Cooperative Oncology Group (ECOG) performance score 0-2 - Absolute neutrophil count (ANC) ≥ 1,500/µL (without growth factors) - Platelet count ≥ 100,000/µL - Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL (177 µmol/L) - Adequate hepatic function: serum total bilirubin ≤ 2X greater than the upper limit of normal (ULN) (≤ 3X ULN in subjects with liver metastases), AST (Aspartate aminotransferase)/ALT (Alanine aminotransferase) ≤ 2X the ULN for the local reference lab (≤ 5X the ULN for subjects with liver metastases) - Disease that can be assessed (evaluable) with imaging (CT, MRI, PET, radionuclide imaging or other imaging modality) - Women of childbearing potential as well as fertile men and their partners must use an effective method of birth control Exclusion Criteria: - Inadequately controlled hypertension defined as BP > 150/100 mm Hg despite medication - Prior history of hypertensive crisis or hypertensive encephalopathy - Recent history (within 6 months of start of screening) of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI), or NYHA (New York Heart Association) Class III and IV Congestive Heart Failure (CHF) - Subjects who have clinical evidence of carcinoid-induced heart disease - History of prior cerebrovascular accident (CVA), including transient ischemic attach (TIA) - Known central nervous system (CNS) disease except for treated brain metastasis - History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG - Corrected QT interval (QTc) > 480 msec - Ongoing treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications (stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed)) - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) - Significant vascular disease or recent peripheral arterial thrombosis - Known intolerance of or hypersensitivity to fosbretabulin - History of solid organ transplant or bone marrow transplant - Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results - High grade or poorly differentiated NET - NET tumor other than PNET or GI-NET - No elevated biomarker (>ULN) that can be followed - Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)
|Official title||A Ph 2 Study to Investigate the Safety and Activity of Fosbretabulin Tromethamine (CA4P) in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET Neuroendocrine Tumors/Carcinoid With Elevated Biomarkers|
|Description||Subjects enrolled in this PNET/GI-NET study (OX4218s) will receive weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks.|
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