A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers

Trial ID or NCT#

NCT02132468

Status

not recruiting iconNOT RECRUITING

Purpose

This study will investigate the safety, symptoms and biomarker response of subjects with biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic pancreatic neuroendocrine tumors (PNETs) or or Gastrointestinal Neuroendocrine tumors (GI-NETs) with elevated biochemical markers who have relapsed during or after receiving prior standard of care therapies, including octreotide, chemotherapy or targeted therapy.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. ≤ 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), aspartate aminotransferase) AST) / alanine aminotransferase (AST) ≤ 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:
  1. * 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)
View All Criteria
Show Less

Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov