Trial Search Results

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

Intestinal neuroendocrine tumors develop in various locations in the body and have been associated with symptoms that are related to the flow of hormones or other substances into the blood stream. This is a research study of intestinal neuroendocrine tumors (NET) that are no longer responding to standard therapies. This research study is being done to see if fosbretabulin, a drug that blocks the blood vessels that feed the cancer, will reduce symptoms of NET and any biomarkers the tumor produces. This study will also include measuring quality of life while taking part in this study.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Mateon Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Drug: fosbretabulin tromethamine

Phase:

Phase 2

Eligibility


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), 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:

   - 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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting