A Phase 2 Study of Fosbretabulin in Subjects With Gastrointestinal Neuroendocrine Tumors With Elevated Biomarkers
Gastrointestinal Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Conditions: Keywords
GI NET, neuroendocrine, carcinoid
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: fosbretabulin tromethamine
Type: Drug
Overall Status
This study will investigate the safety, symptoms and biomarker response of subjects with biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic GI-NETs with elevated biochemical markers who have relapsed during or after receiving prior standard of care therapies, including octreotide, chemotherapy or targeted therapy.
Detailed Description
Subjects enrolled in this GI-NET study (OX4218s) will receive weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 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

- Pancreatic or other non-GI-NET/carcinoid

- 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)
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Pamela L Kunz, MD - 650-725-8738 - pkunz@stanford.edu
Markey Cancer Center, Clinical Research Office
Lexington, Kentucky, United States
Status: Recruiting
Contact: Lowell B Anthony, MD - 859-323-6522 - lowell.anthony@uky.edu
Bronx, New York, United States
Status: Recruiting
Contact: Steven K Libutti, MD - 718-920-4231 - slibutti@montefiore.org
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Julie A Sosa, MD - 919-668-1767 - julie.sosa@duke.edu
Froedtert Hospital, Medicial College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Fabian Johnston, MD - 414-805-5828 - fjohnston@mcw.edu
Start Date
September 2014
Completion Date
December 2016
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page